Sleep Aid — Tablet

Overview

Brand name

Sleep Aid

Generic name

Doxylamine succinate

Dosage form

Tablet

Route

Oral

Marketing category

ANDA · ANDA

Labeler

Rite Aid Corporation

Product type

Human Otc Drug

DEA schedule

Not scheduled

Active ingredients

2

NDC product codes

19

Packages

27

Data completeness

82% of corroborating sources present

Active ingredients

Source: NDC Directory

Active ingredients and strengths as listed in the NDC Directory.
Ingredient	Strength	RxCUI	Monograph
Diphenhydramine Hydrochloride	25 mg/1	1049630	View
Doxylamine Succinate	25 mg/1	1094549	View

Forms, strengths and routes

Source: NDC Directory

Dosage form

Tablet

Route of administration

Oral

Presentations

46

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 H1 Receptor Antagonists [MoA]	MoA	All 136 members
Histamine Receptor Antagonists [MoA]	MoA	All 15 members
Histamine-1 Receptor Antagonist [EPC]	EPC	All 134 members

Regulatory status

Source: Drugs@FDA NDC Directory

Application number

040564

Application type

ANDA · Abbreviated New Drug Application

Approval date

August 27, 2004

Sponsor

LNK

Products on application

1

Submissions recorded

1

Products approved under application 040564.
Product	Trade name	Form	Strength	Ingredient	Status	TE	Flags
040564-001	DOXYLAMINE SUCCINATE	TABLET		DOXYLAMINE SUCCINATE	Over-the-counter	—

Approval history

Source: Drugs@FDA

Most recent submissions on application 040564.
Type	No.	Action	Status	Date	Review
Original application	1		Approved	August 27, 2004	—

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260324). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260324 HUMAN OTC DRUG · 20251219 HUMAN OTC DRUG · 20251202 HUMAN OTC DRUG · 20240328

Indications and Usage

openFDA Drug Labeling

Use • helps to reduce difficulty in falling asleep

Purpose

openFDA Drug Labeling

Purpose Night Time Sleep Aid

Dosage and Administration

openFDA Drug Labeling

DIRECTIONS ■ do not take more than directed (See overdose warning) ■ adults and children 12 years and over: take 2 caplets at bedtime if needed or as directed by doctor ■ children under 12 years: 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 asthma, 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 asthma, 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 Purpose Night sleep-aid

Adverse event reports

Source: openFDA FAERS

172,003

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: DIPHENHYDRAMINE HYDROCHLORIDE. 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
55301-986-27	55301-986	ARMY AND AIR FORCE EXCHANGE SERVICE	2 BLISTER PACK in 1 CARTON (55301-986-27) / 16 TABLET in 1 BLISTER PACK	April 1, 2019
69168-263-30	69168-263	Allegiant Health	30 TABLET in 1 BOTTLE (69168-263-30)	March 3, 2015
69168-263-54	69168-263	Allegiant Health	1 BAG in 1 CARTON (69168-263-54) / 16458 TABLET in 1 BAG	May 8, 2025
69168-263-93	69168-263	Allegiant Health	24 TABLET in 1 BOX (69168-263-93)	March 3, 2015
69168-263-98	69168-263	Allegiant Health	200 TABLET in 1 BOTTLE (69168-263-98)	July 23, 2021
72288-432-01	72288-432	Amazon.com Services LLC	1 BOTTLE in 1 CARTON (72288-432-01) / 96 TABLET in 1 BOTTLE (72288-432-00)	August 27, 2026
63981-986-96	63981-986	COSTCO WHOLESALE CORPORATION	2 BOTTLE, PLASTIC in 1 PACKAGE (63981-986-96) / 96 TABLET in 1 BOTTLE, PLASTIC	May 3, 2019
51316-368-22	51316-368	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	3 BLISTER PACK in 1 CARTON (51316-368-22) / 16 TABLET in 1 BLISTER PACK	June 25, 2025
30142-386-27	30142-386	Kroger Company	2 BLISTER PACK in 1 CARTON (30142-386-27) / 16 TABLET in 1 BLISTER PACK	March 16, 2021
41250-441-01	41250-441	Meijer Distribution Inc	1 BOTTLE in 1 CARTON (41250-441-01) / 96 TABLET in 1 BOTTLE (41250-441-00)	March 5, 2026
41250-986-22	41250-986	Meijer Distribution Inc	3 BLISTER PACK in 1 CARTON (41250-986-22) / 16 TABLET in 1 BLISTER PACK	May 6, 2019
84324-016-01	84324-016	NUVICARE LLC	200 TABLET in 1 BOTTLE (84324-016-01)	July 18, 2024
72090-020-10	72090-020	Pioneer Life Sciences, LLC	100 TABLET in 1 BOTTLE (72090-020-10)	June 29, 2020
56062-441-01	56062-441	Publix Super Markets Inc	1 BOTTLE in 1 CARTON (56062-441-01) / 96 TABLET in 1 BOTTLE	May 16, 2025
11822-0441-0	11822-0441	Rite Aid Corporation	48 BLISTER PACK in 1 CARTON (11822-0441-0) / 1 TABLET in 1 BLISTER PACK	March 13, 2023
11822-0441-1	11822-0441	Rite Aid Corporation	1 BOTTLE in 1 CARTON (11822-0441-1) / 96 TABLET in 1 BOTTLE	March 13, 2023
11822-3000-0	11822-3000	Rite Aid Corporation	24 BLISTER PACK in 1 CARTON (11822-3000-0) / 1 TABLET in 1 BLISTER PACK	July 19, 2023
70677-1129-1	70677-1129	Strategic Sourcing Services LLC	2 BLISTER PACK in 1 CARTON (70677-1129-1) / 16 TABLET in 1 BLISTER PACK	May 3, 2023
41163-986-22	41163-986	United Natural Foods, Inc. dba UNFI	3 BLISTER PACK in 1 CARTON (41163-986-22) / 16 TABLET in 1 BLISTER PACK	June 30, 2019
49035-968-27	49035-968	Wal-Mart Stores Inc	32 TABLET in 1 BOTTLE, PLASTIC (49035-968-27)	July 15, 2019
0363-0386-12	0363-0386	Walgreen Company	1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-12) / 100 TABLET in 1 BOTTLE, PLASTIC	December 31, 2024
0363-0386-22	0363-0386	Walgreen Company	3 BLISTER PACK in 1 CARTON (0363-0386-22) / 16 TABLET in 1 BLISTER PACK	April 5, 2024
0363-0386-31	0363-0386	Walgreen Company	1 BOTTLE, PLASTIC in 1 CARTON (0363-0386-31) / 80 TABLET in 1 BOTTLE, PLASTIC	April 5, 2024
0363-3462-80	0363-3462	Walgreen Company	1 BOTTLE in 1 CARTON (0363-3462-80) / 96 TABLET in 1 BOTTLE	February 14, 2025
73581-205-01	73581-205	YYBA CORP	100 TABLET in 1 BOTTLE (73581-205-01)	January 1, 2025
73581-205-02	73581-205	YYBA CORP	200 TABLET in 1 BOTTLE (73581-205-02)	August 3, 2021
73581-205-10	73581-205	YYBA CORP	10 TABLET in 1 BOTTLE (73581-205-10)	December 2, 2025
55301-986	55301-986	ARMY AND AIR FORCE EXCHANGE SERVICE	—	April 1, 2019
69168-263	69168-263	Allegiant Health	—	March 3, 2015
72288-432	72288-432	Amazon.com Services LLC	—	August 27, 2026
63981-986	63981-986	COSTCO WHOLESALE CORPORATION	—	May 3, 2019
51316-368	51316-368	CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED	—	June 25, 2025
30142-386	30142-386	Kroger Company	—	March 16, 2021
41250-441	41250-441	Meijer Distribution Inc	—	February 21, 1997
41250-986	41250-986	Meijer Distribution Inc	—	May 6, 2019
84324-016	84324-016	NUVICARE LLC	—	July 18, 2024
72090-020	72090-020	Pioneer Life Sciences, LLC	—	June 29, 2020
56062-441	56062-441	Publix Super Markets Inc	—	May 16, 2025
11822-0441	11822-0441	Rite Aid Corporation	—	March 13, 2023
11822-3000	11822-3000	Rite Aid Corporation	—	July 19, 2023
70677-1129	70677-1129	Strategic Sourcing Services LLC	—	May 3, 2023
41163-986	41163-986	United Natural Foods, Inc. dba UNFI	—	June 30, 2019
49035-968	49035-968	Wal-Mart Stores Inc	—	July 15, 2019
0363-0386	0363-0386	Walgreen Company	—	April 5, 2024
0363-3462	0363-3462	Walgreen Company	—	February 14, 2025
73581-205	73581-205	YYBA CORP	—	August 3, 2021

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.