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 26 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gemma Cut the Cramp	ASPIRIN, CAFFEINE	Rally Labs LLC	16c9a296-077a-8e12-e063-6294a90a1b8b	2025-12-29	Warnings	Exact identifier application number: M013
Blowfish	ASPIRIN, CAFFEINE	Rally Labs LLC	0d3798bc-04ef-584e-821b-7aa76036b7d1	2025-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE	Pioneer Life Sciences, LLC	ad29a37f-39a2-5c84-e053-2995a90a2f39	2025-12-29	Warnings	Exact identifier application number: M013
Tension Headache Relief	ACETAMINOPHEN, CAFFEINE	Pioneer Life Sciences, LLC	ac9efd62-8fee-b777-e053-2995a90a3783	2025-12-29	Warnings	Exact identifier application number: M013
Childrens Pain Relief and Fever Reducer Oral Suspension Cherry	ACETAMINOPHEN	Puro Pharma Inc.	a2afaee7-19f3-4a42-a5b8-1d0ef3ecf009	2025-12-27	Warnings	Exact identifier application number: M013
Cystex PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Clarion Brands, LLC	9668a2ca-729e-4172-80b5-33e6c5175ba4	2025-12-27	Warnings	Exact identifier application number: M013
Excedrin Extra Strength Headache	ACETAMINOPHEN, ASPIRIN (NSAID), CAFFEINE	Select Consumer Group	3caa0a47-de83-90d2-e063-6394a90a3436	2025-12-27	Warnings	Exact identifier application number: M013
Aspirin Pain reliver	ASPIRIN	Pioneer Life Sciences, LLC	c2759844-a49c-450f-e053-2a95a90a2972	2025-12-26	Warnings	Exact identifier application number: M013
Menstrual Complete	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	Pioneer Life Sciences, LLC	aa2de3a5-a20d-33c6-e053-2a95a90ada3e	2025-12-26	Warnings	Exact identifier application number: M013
Childrens Pain and Fever	ACETAMINOPHEN	Discount Drug Mart	2aa0f9f3-924c-4a4a-bb5f-2a326acc2408	2025-12-26	Warnings	Exact identifier application number: M013
GenCare Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Pioneer Life Sciences, LLC	667f6f1b-5179-481c-a131-940c7937aada	2025-12-26	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	04dbd98f-c74d-43b2-8bda-74f18be7cf6c	2025-12-24	Warnings	Exact identifier application number: M013
Adult Low Dose Aspirin Enteric Coated	ASPIRIN 81MG	Pharbest Pharmaceuticals, Inc.	45e5bae9-22a7-4699-85ea-5b922af6b96d	2025-12-24	Warnings	Exact identifier application number: M013
Aspirin 325 mg	ASPIRIN	BETTER LIVING BRANDS, LLC	424a242f-c8c6-9dd7-e063-6394a90ab4d5	2025-12-24	Warnings	Exact identifier application number: M013
Low Dose Aspirin	ASPIRIN	Pharbest Pharmaceuticals, Inc.	2763a733-d617-4d95-8429-fbf81d9d77fb	2025-12-24	Warnings	Exact identifier application number: M013
Pharbetol Regular strength	ACETAMINOPHEN	Pharbest Pharmaceuticals, Inc.	e0a39957-d918-4125-88f9-0e550b976fa1	2025-12-24	Warnings	Exact identifier application number: M013
PHARBETOL	ACETAMINOPHEN 500MG	Pharbest Pharmaceuticals, Inc.	27337be9-e279-460e-903e-ae4463099599	2025-12-24	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	PUBLIX SUPERMARKETS, INC	08f5af1d-365b-a97c-e063-6394a90a99ae	2025-12-23	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	0d67bb52-7ae3-439e-9e47-4e21eb0ca352	2025-12-23	Warnings	Exact identifier application number: M013
ACETAMINOPHEN 500 MG	ACETAMINOPHEN	Pioneer Life Sciences, LLC	11e6ec2a-5171-4496-a15f-6ff744bd1f2f	2025-12-23	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