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Nighttime Sleep Aid

Doxylamine succinate · Tablet

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Nighttime Sleep Aid
Generic name
Doxylamine succinate
Dosage form
Tablet
Route
Oral
Marketing category
ANDA · ANDA
Labeler
L.N.K. International, Inc.
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
3
NDC product codes
18
Packages
25
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
Acetaminophen 500 mg/1 313782 View
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
43

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@FDANDC 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 20260415). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20260415 HUMAN OTC DRUG · 20250819 HUMAN OTC DRUG · 20250501 HUMAN OTC DRUG · 20231216

Indications and Usage

openFDA Drug Labeling

Use(s) helps to reduce difficulty in falling asleep

Purpose

openFDA Drug Labeling

Purpose Nighttime 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 a 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 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 products containing diphenhydramine, even one used on skin with other antihistamines

Ask a Doctor

openFDA Drug Labeling

Ask a doctor before use if you have a breathing problem such as asthma, emphysema or chronic bronchitis difficulty in urination due to enlargement of the prostate gland glaucoma

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
679,519
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: ACETAMINOPHEN. 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
69168-439-06 69168-439 Allegiant Health 120 TABLET in 1 BOTTLE (69168-439-06) May 16, 2023
69168-439-40 69168-439 Allegiant Health 40 TABLET in 1 BOTTLE (69168-439-40) November 6, 2023
69168-439-84 69168-439 Allegiant Health 2 BLISTER PACK in 1 CARTON (69168-439-84) / 8 TABLET in 1 BLISTER PACK May 16, 2023
69168-439-98 69168-439 Allegiant Health 200 TABLET in 1 BOTTLE (69168-439-98) November 6, 2023
46122-788-15 46122-788 Amerisource Bergen 2 BLISTER PACK in 1 CARTON (46122-788-15) / 16 TABLET in 1 BLISTER PACK June 7, 2024
21130-986-27 21130-986 Better Living Brands, LLC 2 BLISTER PACK in 1 CARTON (21130-986-27) / 16 TABLET in 1 BLISTER PACK July 15, 2019
37835-812-36 37835-812 Bi-Mart 36 TABLET in 1 BOTTLE (37835-812-36) May 1, 2025
83324-110-32 83324-110 CHAIN DRUG MARKETING ASSOCIATION, INC. 4 BLISTER PACK in 1 CARTON (83324-110-32) / 8 TABLET in 1 BLISTER PACK August 12, 2024
69842-386-22 69842-386 CVS PHARMACY 3 BLISTER PACK in 1 CARTON (69842-386-22) / 16 TABLET in 1 BLISTER PACK July 20, 2019
59779-441-01 59779-441 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-441-01) / 96 TABLET in 1 BOTTLE May 9, 2018
63868-611-32 63868-611 Chain Drug Marketing Association 4 BLISTER PACK in 1 CARTON (63868-611-32) / 8 TABLET in 1 BLISTER PACK June 25, 2007
55319-439-16 55319-439 Family Dollar Stores, Inc 2 BLISTER PACK in 1 CARTON (55319-439-16) / 8 TABLET in 1 BLISTER PACK October 31, 2023
85828-439-38 85828-439 Grocery Outlet 2 BLISTER PACK in 1 CARTON (85828-439-38) / 16 TABLET in 1 BLISTER PACK March 18, 2026
37808-886-27 37808-886 H E B 2 BLISTER PACK in 1 CARTON (37808-886-27) / 16 TABLET in 1 BLISTER PACK July 15, 2019
37808-019-02 37808-019 HEB 2 BLISTER PACK in 1 CARTON (37808-019-02) / 16 TABLET in 1 BLISTER PACK October 31, 2019
69732-005-01 69732-005 Hi-Tech Nutraceuticals, LLC 30 TABLET in 1 BOTTLE, PLASTIC (69732-005-01) April 30, 2020
42507-033-64 42507-033 HyVee Inc 32 BLISTER PACK in 1 CARTON (42507-033-64) / 1 TABLET in 1 BLISTER PACK February 25, 2026
50844-260-21 50844-260 L.N.K. International, Inc. 1 BLISTER PACK in 1 CARTON (50844-260-21) / 16 TABLET in 1 BLISTER PACK July 23, 2019
50844-386-19 50844-386 L.N.K. International, Inc. 1 BLISTER PACK in 1 CARTON (50844-386-19) / 8 TABLET in 1 BLISTER PACK April 11, 2002
50844-386-22 50844-386 L.N.K. International, Inc. 3 BLISTER PACK in 1 CARTON (50844-386-22) / 16 TABLET in 1 BLISTER PACK April 11, 2002
50844-386-27 50844-386 L.N.K. International, Inc. 2 BLISTER PACK in 1 CARTON (50844-386-27) / 16 TABLET in 1 BLISTER PACK April 11, 2002
50844-386-90 50844-386 L.N.K. International, Inc. 32 TABLET in 1 BOTTLE, PLASTIC (50844-386-90) April 11, 2002
50844-386-96 50844-386 L.N.K. International, Inc. 2 BOTTLE, PLASTIC in 1 CARTON (50844-386-96) / 96 TABLET in 1 BOTTLE, PLASTIC April 11, 2002
11673-496-01 11673-496 TARGET CORPORATION 1 BOTTLE in 1 CARTON (11673-496-01) / 100 TABLET in 1 BOTTLE January 15, 2024
63941-219-01 63941-219 VALU MERCHANDISERS COMPANY 4 BLISTER PACK in 1 CARTON (63941-219-01) / 4 TABLET in 1 BLISTER PACK January 19, 2017
69168-439 69168-439 Allegiant Health — May 16, 2023
46122-788 46122-788 Amerisource Bergen — June 7, 2024
21130-986 21130-986 Better Living Brands, LLC — July 15, 2019
37835-812 37835-812 Bi-Mart — May 1, 2025
83324-110 83324-110 CHAIN DRUG MARKETING ASSOCIATION, INC. — August 12, 2024
69842-386 69842-386 CVS PHARMACY — July 20, 2019
59779-441 59779-441 CVS Pharmacy — July 23, 1997
63868-611 63868-611 Chain Drug Marketing Association — June 25, 2007
55319-439 55319-439 Family Dollar Stores, Inc — October 31, 2023
85828-439 85828-439 Grocery Outlet — March 18, 2026
37808-886 37808-886 H E B — July 15, 2019
37808-019 37808-019 HEB — October 31, 2019
69732-005 69732-005 Hi-Tech Nutraceuticals, LLC — April 30, 2020
42507-033 42507-033 HyVee Inc — December 4, 2014
50844-260 50844-260 L.N.K. International, Inc. — July 23, 2019
50844-386 50844-386 L.N.K. International, Inc. — April 11, 2002
11673-496 11673-496 TARGET CORPORATION — January 15, 2024
63941-219 63941-219 VALU MERCHANDISERS COMPANY — January 19, 2017

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.