Acetaminophen Diphenhydramine HCl

Product NDC: 68016-651
Requested package NDC: 68016-651-05
11-digit product format: 680160651
Labeler code: 68016
Product ID: 68016-651_b7b4bbd9-46f6-a0c2-e053-2995a90adf38
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen Diphenhydramine HCl
Dosage form: TABLET
Route: ORAL
Labeler: Pharmacy Value Alliance, LLC
Application: part343
Marketing category: OTC MONOGRAPH NOT FINAL
Marketing start: 2016-02-25
Marketing end: 0000-00-00
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500 mg/1; mg/1
NDC exclude flag: No
Listing certified through: 2021-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	68016-651	68016-651-05	I	Inactivated by FDA		2026-10-05

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 · 16 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source date	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	`1332a3947898…`	`d4bfe170f9cd…`
2020-12-18 03:04 UTC · source 2020-12-17	`e2bbac7714bc…`	`27bdfed8d636…`

Reported adverse events (FAERS/openFDA)#

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

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#

Effective, Related label table
Effective	Related label
2023-01-30	Extra Strength Pain Reliever PM PAIN RELIEVER/NIGHTTIME SLEEP AID Acetaminophen, USP 500 mg each / Diphenhydramine HCl 25 mg each Non-Habit Forming Rapid Release Gelcaps
2020-12-30	Extra Strength Pain Reliever PM PAIN RELIEVER/NIGHTTIME SLEEP AID Acetaminophen, USP 500 mg each / Diphenhydramine HCl 25 mg each Non-Habit Forming Rapid Release Gelcaps
2020-09-27	Extra Strength Pain Reliever PM PAIN RELIEVER/NIGHTTIME SLEEP AID Acetaminophen, USP 500 mg each / Diphenhydramine HCl 25 mg each Non-Habit Forming Rapid Release Gelcaps
2020-09-25	Extra Strength Pain Reliever PM PAIN RELIEVER/NIGHTTIME SLEEP AID Acetaminophen, USP 500 mg each / Diphenhydramine HCl 25 mg each Non-Habit Forming Rapid Release Gelcaps
2020-07-22	Extra Strength Pain Reliever PM PAIN RELIEVER/NIGHTTIME SLEEP AID Acetaminophen, USP 500 mg each / Diphenhydramine HCl 25 mg each Non-Habit Forming Rapid Release Gelcaps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
68016-651-05	Acetaminophen Diphenhydramine HCl	50 in 1 BOTTLE	TABLET	50		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68016-651	ACETAMINOPHEN DIPHENHYDRAMINE HCL TABLET [PHARMACY VALUE ALLIANCE, LLC]	2	Legacy NDC, 1 package rows	20201231_874bbbd4-1256-2867-e053-2995a90a8593.zip

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

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	874bbbd4-1256-2867-e053-2995a90a8593	2
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	874bbbd4-1256-2867-e053-2995a90a8593	2
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	874bbbd4-1256-2867-e053-2995a90a8593	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68016-651-05	68016065105	50 TABLET in 1 BOTTLE (68016-651-05)	50 tablet	2016-02-25	0000-00-00	No	No	Current