---
kind: "section"
citation: "21 C.F.R. § 341.40"
title: "21"
number: "341.40"
heading: "Permitted combinations of active ingredients."
url: "https://uscodex.org/cfr/21/341.40"
---

# §341.40. Permitted combinations of active ingredients.


The following combinations are permitted provided each active ingredient is present within the dosage limits established in parts [341](/cfr/21/part341.md), [343](/cfr/21/part343.md), and 356 of this chapter and the product is labeled in accordance with §§ [341.70](/cfr/21/341.70.md) or [341.85](/cfr/21/341.85.md):

- (a) Any single antihistamine active ingredient identified in [§ 341.12](/cfr/21/341.12.md) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (b) Any single antihistamine active ingredient identified in [§ 341.12](/cfr/21/341.12.md) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (c) Any single antihistamine active ingredient identified in [§ 341.12](/cfr/21/341.12.md) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (d) Any single antihistamine active ingredient identified in § [341.12(a) through (e)](/cfr/21/341.12.md?p=a..e) and [(h) through (m)](/cfr/21/341.12.md?p=h..m) may be combined with any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) provided that the product is labeled according to [§ 341.85(c)(4)](/cfr/21/341.85.md?p=c-4). Diphenhydramine citrate in §§ [341.12(f)](/cfr/21/341.12.md?p=f) and [341.14(a)(5)](/cfr/21/341.14.md?p=a-5) or diphenhydramine hydrochloride in §§ [341.12(g)](/cfr/21/341.12.md?p=g) and [341.14(a)(6)](/cfr/21/341.14.md?p=a-6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to [§ 341.70(a)](/cfr/21/341.70.md?p=a).
- (e) Any single antihistamine active ingredient identified in § [341.12(a) through (e)](/cfr/21/341.12.md?p=a..e) and [(h) through (m)](/cfr/21/341.12.md?p=h..m) may be combined with any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) and any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) provided that the product is labeled according to [§ 341.85(c)(4)](/cfr/21/341.85.md?p=c-4). Diphenhydramine citrate in §§ [341.12(f)](/cfr/21/341.12.md?p=f) and [341.14(a)(5)](/cfr/21/341.14.md?p=a-5) or diphenhydramine hydrochloride in §§ [341.12(g)](/cfr/21/341.12.md?p=g) and [341.14(a)(6)](/cfr/21/341.14.md?p=a-6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to [§ 341.70(a)](/cfr/21/341.70.md?p=a).
- (f) Any single antihistamine active ingredient identified in § [341.12(a) through (e)](/cfr/21/341.12.md?p=a..e) and [(h) through (m)](/cfr/21/341.12.md?p=h..m) may be combined with any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85(c)(4)](/cfr/21/341.85.md?p=c-4). Diphenhydramine citrate in §§ [341.12(f)](/cfr/21/341.12.md?p=f) and [341.14(a)(5)](/cfr/21/341.14.md?p=a-5) or diphenhydramine hydrochloride in §§ [341.12(g)](/cfr/21/341.12.md?p=g) and [341.14(a)(6)](/cfr/21/341.14.md?p=a-6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to [§ 341.70(a)](/cfr/21/341.70.md?p=a).
- (g) Any single antihistamine active ingredient identified in § [341.12(a) through (e)](/cfr/21/341.12.md?p=a..e) and [(h) through (m)](/cfr/21/341.12.md?p=h..m) may be combined with any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) and any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85(c)(4)](/cfr/21/341.85.md?p=c-4). Diphenhydramine citrate in §§ [341.12(f)](/cfr/21/341.12.md?p=f) and [341.14(a)(5)](/cfr/21/341.14.md?p=a-5) or diphenhydramine hydrochloride in §§ [341.12(g)](/cfr/21/341.12.md?p=g) and [341.14(a)(6)](/cfr/21/341.14.md?p=a-6) may be both the antihistamine and the antitussive active ingredient provided that the product is labeled according to [§ 341.70(a)](/cfr/21/341.70.md?p=a).
- (h) Any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) may be combined with any single expectorant active ingredient identified in [§ 341.18](/cfr/21/341.18.md) provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (i) Any single oral antitussive active ingredient identified in [§ 341.14(a)](/cfr/21/341.14.md?p=a) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (j) Any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any single expectorant active ingredient identified in [§ 341.18](/cfr/21/341.18.md) provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (k) Any single antitussive active ingredient identified in § [341.14(a)](/cfr/21/341.14.md?p=a) or [(b)(2)](/cfr/21/341.14.md?p=b-2) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md). If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth. Menthol in [§ 341.14(b)(2)](/cfr/21/341.14.md?p=b-2) and [part 356](/cfr/21/part356.md) of this chapter may be both the antitussive and the anesthetic/analgesic active ingredient provided that the product is labeled according to [§ 341.70(b)](/cfr/21/341.70.md?p=b).
- (l) Any single oral antitussive active ingredient identified in [§ 341.14(a)](/cfr/21/341.14.md?p=a) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (m) Any single oral antitussive active ingredient identified in [§ 341.14(a)](/cfr/21/341.14.md?p=a) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (n) Any single oral antitussive active ingredient identified in [§ 341.14(a)(1) through (a)(4)](/cfr/21/341.14.md?p=a-1..a-4) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any single expectorant active ingredient identified in [§ 341.18](/cfr/21/341.18.md) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (o) Any single expectorant active ingredient identified in [§ 341.18](/cfr/21/341.18.md) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (p) Any single expectorant active ingredient identified in [§ 341.18](/cfr/21/341.18.md) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (q) Any single expectorant active ingredient identified in [§ 341.18](/cfr/21/341.18.md) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (r) Any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) may be combined with any generally recognized as safe and effective single analgesic-antipyretic active ingredient, or any combination of acetaminophen with other analgesic-antipyretic active ingredients, or any aspirin and antacid combination provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (s) Any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient identified, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (t) Any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) may be combined with any single antitussive active ingredient identified in § [341.14(a)](/cfr/21/341.14.md?p=a) or [(b)(2)](/cfr/21/341.14.md?p=b-2) and any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient, or any combination of anesthetic/analgesic active ingredients provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md). If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
- (u) Camphor identified in [§ 341.14(b)(1)](/cfr/21/341.14.md?p=b-1) may be combined with menthol identified in [§ 341.14(b)(2)](/cfr/21/341.14.md?p=b-2) and eucalyptus oil (1.2 to 1.3 percent) provided that the product is available only in a suitable ointment vehicle and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (v) Levmetamfetamine identified in [§ 341.20(b)(1)](/cfr/21/341.20.md?p=b-1) may be combined with aromatics (camphor (54 milligrams (mg)), menthol (80 mg), methyl salicylate (11 mg), and lavender oil (4 mg)) provided that the product is available only as a nasal inhaler and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (w) Any single antitussive active ingredient identified in § [341.14(a)](/cfr/21/341.14.md?p=a) or [(b)(2)](/cfr/21/341.14.md?p=b-2) may be combined with any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md). If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
- (x) Any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) may be combined with any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (y) Any single antitussive active ingredient identified in § [341.14(a)](/cfr/21/341.14.md?p=a) or [(b)(2)](/cfr/21/341.14.md?p=b-2) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md). If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
- (z) Any single antitussive active ingredient identified in § [341.14(a)](/cfr/21/341.14.md?p=a) or [(b)(2)](/cfr/21/341.14.md?p=b-2) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient or any combination of anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md). If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.
- (aa) Any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) may be combined with any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient or any combination of oral anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md).
- (bb) Any single antitussive active ingredient identified in § [341.14(a)](/cfr/21/341.14.md?p=a) or [(b)(2)](/cfr/21/341.14.md?p=b-2) may be combined with any single oral nasal decongestant active ingredient identified in [§ 341.20(a)](/cfr/21/341.20.md?p=a) and any generally recognized as safe and effective single oral anesthetic/analgesic active ingredient identified or any combination of anesthetic/analgesic active ingredients and any generally recognized as safe and effective single oral demulcent active ingredient provided that the product is available in either a liquid (to be swallowed) or a solid dosage form (to be dissolved in the mouth and swallowed) and provided that the product is labeled according to [§ 341.85](/cfr/21/341.85.md). If the combination contains a topical antitussive, the product must be formulated in a solid dosage form to be dissolved in the mouth.

## Notes

### Amendments

[67 FR 78168, Dec. 23, 2002]

### Authority

Authority: 21 U.S.C. 321, 351, 352, 353, 355, 360, 371.

### Amendments

[67 FR 78168, Dec. 23, 2002]