21 CFR §330.5
Verified against eCFR.gov as of June 20, 2026View official text on eCFR.gov ↗
Monographs promulgated pursuant to the provisions of this part shall be established in this part 330 and following parts and shall cover the following designated categories:
- (a)Antacids.
- (b)Laxatives.
- (c)Antidiarrheal products.
- (d)Emetics.
- (e)Antiemetics.
- (f)Antiperspirants.
- (g)Sunburn prevention and treatment products.
- (h)Vitamin-mineral products.
- (i)Antimicrobial products.
- (j)Dandruff products.
- (k)Oral hygiene aids.
- (l)Hemorrhoidal products.
- (m)Hematinics.
- (n)Bronchodilator and antiasthmatic products.
- (o)Analgesics.
- (p)Sedatives and sleep aids.
- (q)Stimulants.
- (r)Antitussives.
- (s)Allergy treatment products.
- (t)Cold remedies.
- (u)Antirheumatic products.
- (v)Ophthalmic products.
- (w)Contraceptive products.
- (x)Miscellaneous dermatologic products.
- (y)Dentifrices and dental products such as analgesics, antiseptics, etc.
- (z)Miscellaneous (all other OTC drugs not falling within one of the above therapeutic categories).