TopCare Sleep Aid — Tablet

Overview

Brand name

TopCare Sleep Aid

Generic name

Doxylamine succinate

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Topco Associates LLC

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

1

NDC product codes

2

Packages

3

Data completeness

76% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Doxylamine Succinate	25 mg/1	1094549	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

5

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory

Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class	Type	Browse
Antihistamine [EPC]	EPC	All 15 members
Histamine Receptor Antagonists [MoA]	MoA	All 15 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

040167

Application type

ANDA · Abbreviated New Drug Application

Approval date

September 18, 1996

Sponsor

PERRIGO

Products on application

1

Submissions recorded

14

Products approved under application 040167.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
040167-001	DOXYLAMINE SUCCINATE	TABLET		DOXYLAMINE SUCCINATE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 040167.
Type	No.	Action	Status	Date	Review
Supplement	52	Manufacturing (CMC)	Approved	April 4, 2024	Unknown
Supplement	51	Manufacturing (CMC)	Approved	February 20, 2024	Unknown
Supplement	50	Labeling	Approved	October 6, 2023	Standard
Supplement	43	Labeling	Approved	March 6, 2015	Standard
Supplement	41	Manufacturing (CMC)	Approved	October 9, 2014	—
Supplement	33	Labeling	Approved	June 2, 2009	—
Supplement	31	Labeling	Approved	July 14, 2008	—
Supplement	6	Labeling	Approved	September 10, 2002	—
Supplement	5	Manufacturing (CMC)	Approved	October 4, 2001	—
Supplement	4	Manufacturing (CMC)	Approved	October 4, 2001	—
Supplement	3	Manufacturing (CMC)	Approved	January 21, 1999	—
Supplement	2	Manufacturing (CMC)	Approved	February 10, 1998	—
Supplement	1	Manufacturing (CMC)	Approved	February 10, 1998	—
Original application	1		Approved	September 18, 1996	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20250216). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20250216 HUMAN OTC DRUG · 20240328

Indications and Usage

openFDA Drug Labeling

Use • helps to reduce difficulty in falling asleep

Purpose

openFDA Drug Labeling

Purpose Nighttime sleep-aid

Dosage and Administration

openFDA Drug Labeling

Directions • adults and children 12 years of age and over: take one tablet 30 minutes before going to bed; take once daily or as directed by a doctor • children under 12 years of age: do not use

Warnings

openFDA Drug Labeling

Warnings Do not use • in children under 12 years of age • with any other product containing doxylamine • unless you have time for a full night’s sleep Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland Ask a doctor or pharmacist before use if you are taking • a sedative or any other sleep-aid • tranquilizers • any other antihistamines • any other drugs When using this product • avoid alcoholic beverages • do not drive a motor vehicle or operate machinery • take only at bedtime Stop use and ask a doctor if • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Do Not Use

openFDA Drug Labeling

Do not use • in children under 12 years of age • with any other product containing doxylamine • unless you have time for a full night’s sleep

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have • a breathing problem such as emphysema or chronic bronchitis • glaucoma • trouble urinating due to an enlarged prostate gland

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • sleeplessness persists continuously for more than two weeks. Insomnia may be a symptom of serious underlying medical illness.

Active Ingredient

openFDA Drug Labeling

Active ingredient (in each tablet) Doxylamine succinate 25 mg

Adverse event reports

Source: openFDA FAERS

7,688

FAERS reports mentioning this drug

as of 2026-09-25T03:42:24+00:00

A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: DOXYLAMINE SUCCINATE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory

Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC	Product NDC	Labeler	Description	Marketing start
36800-441-64	36800-441	Topco Associates LLC	32 BLISTER PACK in 1 CARTON (36800-441-64) / 1 TABLET in 1 BLISTER PACK	January 29, 1997
76162-159-62	76162-159	Topco Associates LLC	24 BLISTER PACK in 1 CARTON (76162-159-62) / 1 TABLET in 1 BLISTER PACK	June 16, 2023
76162-159-67	76162-159	Topco Associates LLC	48 BLISTER PACK in 1 CARTON (76162-159-67) / 1 TABLET in 1 BLISTER PACK	January 24, 2024
36800-441	36800-441	Topco Associates LLC	—	January 29, 1997
76162-159	76162-159	Topco Associates LLC	—	June 16, 2023

Sources for this page

Every dataset that contributed a fact to this page.
Dataset	Agency	Used for
NDC Directory	FDA	Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA	FDA	Application, sponsor, submissions, review documents, marketing status
Drug Labeling	FDA / NLM	Prescribing information reproduced above
FAERS	FDA	Adverse event report counts

Generated September 25, 2026 · 10 sections on this page.