Nighttime Sleep Aid

Product NDC: 69732-005
11-digit product format: 697320005
Labeler code: 69732
Product ID: 69732-005_55f8f71f-4c2c-6161-e063-6394a90a6a8e
Type: HUMAN OTC DRUG
Nonproprietary name: acetaminophen, diphenhydramine
Dosage form: TABLET
Route: ORAL
Labeler: Hi-Tech Nutraceuticals, LLC
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2020-04-30
Substance: DIPHENHYDRAMINE HYDROCHLORIDE; ACETAMINOPHEN
Active strength: 25; 500 mg/1; mg/1
Pharmacologic classes: Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 30 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	69732-005-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	69732-005-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	69732-005-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	69732-005-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	69732-005-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	69732-005-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	69732-005-01	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	69732-005-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	69732-005-01	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	69732-005-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	69732-005-01	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	69732-005-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	69732-005-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	69732-005-01	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	69732-005-01	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: Nighttime Sleep Aid
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DIPHENHYDRAMINE HYDROCHLORIDE	25 mg/1
ACETAMINOPHEN	500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
TC2D6JAD40	Internal UNII lookup
362O9ITL9D	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1092189	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a39e2bd6-3d0a-642b-e053-2995a90a42a0	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
0e2e0f88-b076-afe1-4bdd-32bca4375bec	Product name	3	20250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54	Product name	1	20140508
865c72dd-0d94-daac-f728-ddd4ded2a79e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69732-005-01	2024-01-30	C162847	48780-1	1030e365-1698-111a-e063-dadaa90a10e2	Sleep Aid
69732-005-01	2024-01-30	C162847	48780-1	1030e365-1698-111a-e063-dadaa90a10e2	Sleep Aid

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69732-005-01	Nighttime Sleep Aid	30 in 1 BOTTLE, PLASTIC	TABLET	30		3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69732-005	NIGHTTIME SLEEP AID (ACETAMINOPHEN, DIPHENHYDRAMINE) TABLET [HI-TECH NUTRACEUTICALS, LLC]	3	Current NDC, Legacy NDC, 1 package rows	20230101_a39e2bd6-3d0a-642b-e053-2995a90a42a0.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 25 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pain Reliever Extra Strength	ACETAMINOPHEN	L.N.K. International, Inc.	8fed703a-9de2-4c76-a783-fcf004f9b890	2026-01-07	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Amerisource Bergen	c3099892-a8cd-4574-a6f9-041e59e2feae	2026-01-07	Warnings	Exact identifier application number: M013
Bactimicina Childrens Pain and Fever	ACETAMINOPHEN	DLC Laboratories, Inc.	bdade270-d813-4178-b594-4951632b6839	2026-01-07	Warnings	Exact identifier application number: M013
Goodmeds Extra Strength Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE	Cabinet Health P.B.C.	02c60967-46d7-49b7-82be-bc3c5fd36484	2026-01-06	Warnings	Exact identifier application number: M013
Childrens Acetaminophen	ACETAMINOPHEN	ARMY AND AIR FORCE EXCHANGE SERVICE	a73f8217-9eae-4e2a-b29c-7de3861d0e37	2026-01-06	Warnings	Exact identifier application number: M013
Pain Relief Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HCL	Rite Aid Corporation	f77f0120-4042-4b11-ba9c-cd35e1cd0bee	2026-01-05	Warnings	Exact identifier application number: M013
Menstrual Relief Maximum Strength	ACETAMINOPHEN, CAFFEINE AND PYRILAMINE MALEATE	United Natural Foods, Inc. dba UNFI	807598ef-9f03-48df-b076-3ee95ef4b06c	2026-01-05	Warnings	Exact identifier application number: M013
Pain Relief Extra Strength, Non-Aspirin	ACETAMINOPHEN	CHAIN DRUG MARKETING ASSOCIATION INC	1fb5e871-45fd-46fe-bf73-5192f8316e8e	2026-01-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN	Valu Merchandisers Company	0005aafa-08f8-4990-a54d-cc097195708f	2026-01-02	Warnings	Exact identifier application number: M013
Extra Strength Pain Reliever	ACETAMINOPHEN	Walmart Inc.	152bb455-da5b-ae13-e063-6394a90acab0	2026-01-01	Warnings	Exact identifier application number: M013
Dr. Cocoa for Children Pain and Fever	ACETAMINOPHEN	Infirst Healthcare Inc.	486ea294-6d18-a907-e063-6294a90ad284	2026-01-01	Warnings	Exact identifier application number: M013
ED APAP	ACETAMINOPHEN	EDWARDS PHARMACEUTICALS, INC.	f76d5fff-ebea-40f9-aad3-4064a0c863f0	2025-12-31	Warnings	Exact identifier application number: M013
EXTRA STRENGTH PAIN RELIEF	ACETAMINOPHEN	GERI-CARE PHARMACEUTICAL CORP	99ec63ef-aa28-c2fb-e053-2a95a90a9f6d	2025-12-31	Warnings	Exact identifier application number: M013
Puregen Labs Acetaminophen	ACETAMINOPHEN	Advanced Rx LLC	474580af-f6b0-e440-e063-6394a90aaada	2025-12-31	Warnings	Exact identifier application number: M013
Liquid Acetaminophen	ACETAMINOPHEN	LLORENS PHARMACEUTICALS INTERNATIONAL DIVISION	a7dbd4c0-53eb-4368-917b-1432c09ce6b4	2025-12-31	Warnings	Exact identifier application number: M013
Llorens Care Children Acetaminophen	ACETAMINOPHEN	Llorens Pharmaceutical International Division, Inc.	2a46d7d2-293b-5024-e063-6294a90a31aa	2025-12-31	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN CAPSULES 500MG (MINIS-RED OPAQUE)	Walgreens	3a801457-c5d0-b134-e063-6294a90ac5cb	2025-12-31	Warnings	Exact identifier application number: M013
Daytime and Nighttime Severe Cold and Flu combo pack	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE	Genexa Inc.	190c7eaf-dcd4-d314-e063-6294a90a6f33	2025-12-30	Warnings	Exact identifier application number: M013
BioElectro Extra Strength Headache Relief	ACETAMINOPHEN, ASPIRIN, AND CAFFEINE	Genomma Lab USA	683a0fba-921c-48e7-a391-180c04f0d1c4	2025-12-30	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	0181af13-da32-4431-be39-c31fdfac9202	2025-12-29	Warnings	Exact identifier application number: M013

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
TC2D6JAD40	DIPHENHYDRAMINE HYDROCHLORIDE	147-24-0	DIPHENHYDRAMINE HYDROCHLORIDE
362O9ITL9D	ACETAMINOPHEN	103-90-2	ACETAMINOPHEN

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1092189	acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral Tablet	PSN	a39e2bd6-3d0a-642b-e053-2995a90a42a0	3
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	a39e2bd6-3d0a-642b-e053-2995a90a42a0	3
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	a39e2bd6-3d0a-642b-e053-2995a90a42a0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
69732-005-01	69732000501	30 TABLET in 1 BOTTLE, PLASTIC (69732-005-01)	30 tablet	2020-04-30	0000-00-00	No	No	Current