eCFR Reference Browser

---

title: "21 CFR §330.5"

source: "https://www.ecfr.gov/current/title-21/section-330.5"

title_number: "21"

volume_number: "5"

chapter_number: "Unknown"

subchapter_code: "D"

subchapter_subject: "DRUGS FOR HUMAN USE"

part_code: "330"

part_subject: "OVER-THE-COUNTER (OTC) HUMAN DRUGS WHICH ARE GENERALLY RECOGNIZED AS SAFE AND EFFECTIVE AND NOT MISBRANDED"

subpart_code: "A"

subpart_subject: "General Provisions"

section_number: "330.5"

section_subject: "Drug categories."

cfr_reference: "21 CFR 330.5"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 300 to 499"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

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).

§330.5 - Drug categories.