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 8 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Extra Strength Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a36be487-7a36-550f-e053-2a95a90a95c1	2026-07-06	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Hi-Tech Nutraceuticals, LLC	a39c524e-c131-d7fb-e053-2995a90a785b	2026-07-06	Warnings	Exact identifier application number: M013
PAIN RELIEVER	ASPIRIN 81 MG	Health Pharma USA, LLC	d60aed37-3a9e-46d1-e053-2995a90a1d1f	2026-07-06	Warnings	Exact identifier application number: M013
Tylenol PM Extra Strength	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	Select Consumer Group	55d0dceb-c9a9-778e-e063-6294a90a2ad7	2026-07-04	Warnings	Exact identifier application number: M013
Bayer Genuine Aspirin	ASPIRIN	Select Consumer Group	3ca776c2-47ed-5107-e063-6394a90ac5df	2026-07-03	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	Rugby Laboratories	f7ca9f4a-f8ef-46d2-9536-b69541e6653d	2026-07-02	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	United Natural Foods, Inc. dba UNFI	19c7f832-d7ec-4dcc-8aa4-f4cbf64c9ff6	2026-07-02	Warnings	Exact identifier application number: M013
Regular Strength Enteric coated aspirin	ASPIRIN	St. Mary's Medical Park Pharmacy	33733144-b26a-b4a3-e063-6294a90ae049	2026-07-01	Warnings	Exact identifier application number: M013
pain relief EXTRA STRENGTH	ACETAMINOPHEN	Meijer Distribution, Inc.	ae84eb7e-a70b-4311-b2dc-ad153047a516	2026-07-01	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	Hi-Tech Nutraceuticals, LLC	b3426a9a-ea99-da30-e053-2995a90a1e4b	2026-07-01	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Salado Sales, Inc.	ca21d576-be3c-495d-9dbd-ed514bf65da7	2026-07-01	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Meijer Distribution Inc	4e08a7cb-3894-84c3-e063-6394a90a0b42	2026-06-30	Warnings	Exact identifier application number: M013
Aspirin	ASPIRIN	St. Mary's Medical Park Pharmacy	0cca91cb-f05b-3cf8-e063-6394a90a9f79	2026-06-30	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Wal-Mart Stores Inc	9b1201af-c802-4e19-b192-bbbf34367db4	2026-06-30	Warnings	Exact identifier application number: M013
Pain Reliever	ACETAMINOPHEN	P & L Development, LLC	fc841cba-8f4f-407b-97de-0422977515bd	2026-06-30	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	United Natural Foods, Inc. dba UNFI	b6ff2b34-51ee-41bc-8b7d-7520ade0bf36	2026-06-30	Warnings	Exact identifier application number: M013
Medline	ASPIRIN	Medline Industries, LP	4b0c569a-ed7a-e104-e063-6394a90a6d54	2026-06-29	Warnings	Exact identifier application number: M013
Extra Strength Pain Relief	ACETAMINOPHEN	St. Mary's Medical Park Pharmacy	31ce5c80-152f-12a1-e063-6394a90ab119	2026-06-29	Warnings	Exact identifier application number: M013
Pain Reliever PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	WALMART INC.	e50b3f60-b827-426c-8e78-8447c89130fe	2026-06-29	Warnings	Exact identifier application number: M013
Acetaminophen PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Chain Drug Marketing Association, Inc.	e58417f4-3575-4433-ac2e-b7bf9fe8ba10	2026-06-29	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