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 32 of 83 · 1,657 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
BAYER Aspirin Extra Strength Caplets	BAYER ASPIRIN EXTRA STRENGTH	Bayer HealthCare LLC.	0ae64cdb-4ea0-23af-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Chewable - Aspirin Regimen Low Dose Aspirin Cherry Flavored	ASPIRIN	Bayer HealthCare LLC.	070d5713-e018-2913-e054-00144ff8d46c	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Low Dose	ASPIRIN	Bayer HealthCare LLC.	075b103e-0bb4-4b7a-ac0e-5645bcbd0a07	2025-12-04	Warnings	Exact identifier application number: M013
Alka-Seltzer Original	ANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATE	Bayer HealthCare LLC.	5be36a7f-7d1f-468d-9c29-92c8cd3ef1bc	2025-12-04	Warnings	Exact identifier application number: M013
Bayer Aspirin Regimen enteric coated	ASPIRIN	Bayer HealthCare LLC.	0c6ae05f-7634-34d1-e054-00144ff88e88	2025-12-04	Warnings	Exact identifier application number: M013
aspirin pain relief	ASPIRIN	Rite Aid Corporation	ae9d9977-7576-4894-8a32-454828abec9a	2025-12-04	Warnings	Exact identifier application number: M013
Headache Relief	ACETAMINOPHEN, ASPIRIN, CAFFEINE	L.N.K. International, Inc.	e51fc0d6-9b32-478c-bab7-328013e692b0	2025-12-04	Warnings	Exact identifier application number: M013
Headache Relief Extra Strength	ACETAMINOPHEN, ASPIRIN, CAFFEINE	Meijer Distribution Inc	04f2c3ed-4bcf-4b6a-b8fb-0aa6ecb3dca2	2025-12-04	Warnings	Exact identifier application number: M013
ASPIRIN	ASPIRIN	RMT HEALTH LLC	2bacffd1-4870-73af-e063-6294a90a19c8	2025-12-02	Warnings	Exact identifier application number: M013
Pain Reliever Extra Strength	ACETAMINOPHEN, ASPIRIN AND CAFFEINE	Rite Aid Corporation	d9caee45-be43-45ec-927f-e7fec5c14f07	2025-12-02	Warnings	Exact identifier application number: M013
Acetaminophen	ACETAMINOPHEN	Major Pharmaceuticals	e1a55e0d-bb86-4515-8436-51a74b403685	2025-12-02	Warnings	Exact identifier application number: M013
Pain Reliever PM Extra Strength	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	Walgreen Company	b4d8860b-d72f-4789-945e-1c6420a8efab	2025-12-02	Warnings	Exact identifier application number: M013
Infants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	f7b304d8-e37c-4ac6-b4a2-1797b92cb832	2025-12-01	Warnings	Exact identifier application number: M013
Dye FreeInfants Pain and Fever	ACETAMINOPHEN	WALGREEN COMPANY	1a304570-88b6-4c16-a8b4-c064bfa5d95a	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Severe Multi-Symptom Cough Cold Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE	WALGREENS	b48d93fe-bb60-493f-8d1a-b2dc864203c4	2025-12-01	Warnings	Exact identifier application number: M013
Multi Symptom Severe Cold and Nighttime Severe Cold and Cough	ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL	WALGREEN CO.	6c4ab613-a587-4ec4-9986-f1d000bc2d23	2025-12-01	Warnings	Exact identifier application number: M013
WAG HBP Daytime and Nighttime Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE	WALGREENS CO.	ac2f9ce8-e402-4451-a412-e99248a6ecbe	2025-12-01	Warnings	Exact identifier application number: M013
Walgreen Day Time NightTime Cold and Flu Relief	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE,GUAIFENESIN	WALGREENS CO.	5505217a-9679-4668-bdab-5d4553a47c56	2025-12-01	Warnings	Exact identifier application number: M013
Vicks PainQuil and Vicks PainQuil PM PAIN RELIEVER	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	The Procter & Gamble Manufacturing Company	163a1617-b7f1-4c80-e063-6394a90a74c3	2025-12-01	Warnings	Exact identifier application number: M013
CAREALL Aspirin	ASPIRIN	New World Imports, Inc	58a371d4-1f00-4fda-8e08-80610c58505a	2025-12-01	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