# 21 C.F.R. § 310.519 (2026): Drug products marketed as over-the-counter (OTC) daytime sedatives > Federal · Regulations · In force URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_519 ## Section - **Citation:** 21 C.F.R. § 310.519 (2026) - **Heading:** Drug products marketed as over-the-counter (OTC) daytime sedatives - **Jurisdiction:** Federal - **Kind:** Regulations - **Status:** In force - **Text as of:** August 14, 2026 - **Source:** Compiled text - **Location:** Title 21 CFR: Food and Drugs / Chapter I / Part 310 / Subpart E / § 310.519: § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives. ## Text (a) Antihistamines, bromides, and scopolamine compounds, either singly or in combinations, have been marketed as ingredients in over-the-counter (OTC) drug products for use as daytime sedatives. The following claims have been made for daytime sedative products: “occasional simple nervous tension,” “nervous irritability,” “nervous tension headache,” “simple nervousness due to common every day overwork and fatigue,” “a relaxed feeling,” “calming down and relaxing,” “gently soothe away the tension,” “calmative,” “resolving that irritability that ruins your day,” “helps you relax,” “restlessness,” “when you're under occasional stress . . . helps you work relaxed.” Based on evidence presently available, there are no ingredients that can be generally recognized as safe and effective for use as OTC daytime sedatives. (b) Any OTC drug product that is labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication) is regarded as a new drug within the meaning of section 201(p) of the Federal Food, Drug, and Cosmetic Act for which an approved new drug application under section 505 of the act and part 314 of this chapter is required for marketing. (c) Clinical investigations designed to obtain evidence that any drug product labeled, represented, or promoted as an OTC daytime sedative (or any similar or related indication) is safe and effective for the purpose intended must comply with the requirements and procedures governing the use of investigational new drugs set forth in part 312 of this chapter. (d) Any OTC daytime sedative drug product introduced into interstate commerce after December 24, 1979, that is not in compliance with this section is subject to regulatory action. [44 FR 36380, June 22, 1979; 45 FR 47422, July 15, 1980, as amended at 55 FR 11579, Mar. 29, 1990] ## Nearby sections - [21 C.F.R. § 310.501 (2026) § 310.501 Patient package inserts for oral contraceptives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_501.md) - [21 C.F.R. § 310.502 (2026) § 310.502 Certain drugs accorded new drug status through rulemaking procedures.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_502.md) - [21 C.F.R. § 310.503 (2026) § 310.503 Requirements regarding certain radioactive drugs.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_503.md) - [21 C.F.R. § 310.509 (2026) § 310.509 Parenteral drug products in plastic containers.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_509.md) - [21 C.F.R. § 310.515 (2026) § 310.515 Patient package inserts for estrogens.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_515.md) - [21 C.F.R. § 310.517 (2026) § 310.517 Labeling for oral hypoglycemic drugs of the sulfonylurea class.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_517.md) - [21 C.F.R. § 310.518 (2026) § 310.518 Drug products containing iron or iron salts.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_518.md) - [21 C.F.R. § 310.519 (2026) § 310.519 Drug products marketed as over-the-counter (OTC) daytime sedatives.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_519.md) - [21 C.F.R. § 310.527 (2026) § 310.527 Drug products containing active ingredients offered over-the-counter (OTC) for external use as hair growers or for hair loss prevention.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_527.md) - [21 C.F.R. § 310.528 (2026) § 310.528 Drug products containing active ingredients offered over-the-counter (OTC) for use as an aphrodisiac.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_528.md) - [21 C.F.R. § 310.529 (2026) § 310.529 Drug products containing active ingredients offered over-the-counter (OTC) for oral use as insect repellents.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_529.md) - [21 C.F.R. § 310.530 (2026) § 310.530 Topically applied hormone-containing drug products for over-the-counter (OTC) human use.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_530.md) - [21 C.F.R. § 310.531 (2026) § 310.531 Drug products containing active ingredients offered over-the-counter (OTC) for the treatment of boils.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_531.md) - [21 C.F.R. § 310.532 (2026) § 310.532 Drug products containing active ingredients offered over-the-counter (OTC) to relieve the symptoms of benign prostatic hypertrophy.](https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_532.md) --- Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P310_S310_519. Check the current official text before relying on it. Not legal advice.