Acetaminophen PM

Product NDC: 69842-956
11-digit product format: 698420956
Labeler code: 69842
Product ID: 69842-956_47ca6770-e94f-4ccf-ac53-ddbccfd93d22
Type: HUMAN OTC DRUG
Nonproprietary name: Acetaminophen, Diphenhydramine HCl
Dosage form: TABLET, COATED
Route: ORAL
Labeler: CVS PHARMACY
Application: M013
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2007-12-17
Substance: ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength: 500; 25 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

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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	69842-956	69842-956-09	D	Discontinued by firm		2026-10-27
excluded package	package	69842-956	69842-956-13	D	Discontinued by firm		2026-10-27

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 · 24 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	69842-956-13	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	69842-956-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	69842-956-13	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	69842-956-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	69842-956-13	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	69842-956-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	69842-956-13	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	69842-956-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	69842-956-13	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	69842-956-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	69842-956-13	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	69842-956-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	69842-956-13	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	69842-956-09	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	69842-956-13	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	69842-956-09	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	69842-956-13	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	69842-956-09	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	69842-956-13	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	69842-956-09	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	69842-956-13	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	69842-956-09	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	69842-956-09	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	69842-956-13	`557ba5c1ecfa…`	`9c80585c8c6e…`

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: Acetaminophen PM
Brand name suffix: Extra Strength
Listing expiration: 2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
362O9ITL9D	Internal UNII lookup
TC2D6JAD40	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
67a190c3-7de0-4f57-be94-d6b8285e1220	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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
69842-956-09	Acetaminophen PMExtra Strength	1 in 1 CARTON	TABLET, COATED	1	12
69842-956-09	Acetaminophen PMExtra Strength	20 in 1 BOTTLE, PLASTIC	TABLET, COATED	20	12
69842-956-13	Acetaminophen PMExtra Strength	250 in 1 BOTTLE	TABLET, COATED	250	12
69842-956-31	Acetaminophen PMExtra Strength	80 in 1 BOTTLE, PLASTIC	TABLET, COATED	80	12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69842-956	ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [CVS PHARMACY]	11	Current NDC, Legacy NDC, 4 package rows	20250327_67a190c3-7de0-4f57-be94-d6b8285e1220.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 73 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DOLODOL	ACETAMINOPHEN, ASPIRIN, CAFFEINE	OPMX LLC	e80536f1-92cc-5bb3-e053-2995a90a9540	2024-01-26	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	d913d11f-c7a1-49d2-a2d3-9a29fc032806	2024-01-18	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	Bryant Ranch Prepack	64c28b38-23bb-4c7e-9c19-1d1f0d597528	2024-01-18	Warnings	Exact identifier application number: M013
Buscapina	ACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATE	OPMX LLC	e0dd4c04-6811-38a1-e053-2995a90aa3c9	2024-01-17	Warnings	Exact identifier application number: M013
Regular Strength Acetaminophen	ACETAMINOPHEN	CARDINAL HEALTH	bdf8c511-ce25-0e30-e053-2a95a90a33f6	2024-01-10	Warnings	Exact identifier application number: M013
Extra Strength Acetaminophen PM	ACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDE	KROGER COMPANY	2560126e-a54a-4a47-9631-a1bca42f5277	2024-01-10	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	A-S Medication Solutions	ee4451c9-4d0f-4373-8f64-fcc1f9dd5856	2024-01-05	Warnings	Exact identifier application number: M013
Pharbetol	ACETAMINOPHEN	Proficient Rx LP	51ba690e-d76b-41c6-a083-8bc803e1faa2	2024-01-01	Warnings	Exact identifier application number: M013
MEDI-FIRST Non-Aspirin Extra Strength	ACETAMINOPHEN	Proficient Rx LP	9071b047-5463-4f65-b775-bfb0ce066527	2024-01-01	Warnings	Exact identifier application number: M013
LOW DOSE ASPIRIN	ASPIRIN	TIME CAP LABORATORIES, INC	1acc8c1a-c746-4635-800c-de1ad758fce0	2023-12-30	Warnings	Exact identifier application number: M013
MAX Cold, Flu, and Sore Throat	ACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN , PHENYLEPHRINE HCL	H E B	9b09b660-0758-48dc-84c9-26cdd2aacc03	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Original	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	eb24323f-82a1-4ba3-9359-fe81571c3fba	2023-12-29	Warnings	Exact identifier application number: M013
Nite-TimeCOLD/FLU CHERRY COLD/FLU CHERRY	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	e6c3e545-b2ad-47f0-8318-c134a8e24f5b	2023-12-29	Warnings	Exact identifier application number: M013
Daytime Non-Drowsy COLD/FLU	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	Salado Sales, Inc.	e181b371-78c7-4163-865d-acc064be33ca	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever Cherry flavor	ACETAMINOPHEN	Walgreen Company	64c65244-f7a3-401b-b83a-bf66d45268e2	2023-12-29	Warnings	Exact identifier application number: M013
Nite-Time COLD/FLU ORIGINAL	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	Salado Sales, Inc.	fcd24753-b42b-4d05-8379-0ec0351ab217	2023-12-29	Warnings	Exact identifier application number: M013
NIGHT-TIME MULTI-SYMPTOM COLD/FLU Cherry	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE	DeMoulas Market Basket	e772cdf5-d01d-4752-8cfb-7e7f4d7a8dd0	2023-12-29	Warnings	Exact identifier application number: M013
Childrens Pain and Fever, Grape flavor	ACETAMINOPHEN	Walgreen Company	0995d69f-61aa-40b0-b095-bb8595caf773	2023-12-29	Warnings	Exact identifier application number: M013
DAY-TIME Cold and Flu	ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE	DeMoulas Market Basket	ce900e42-d0c8-408d-a1c3-3a9bef1c97ee	2023-12-29	Warnings	Exact identifier application number: M013
Pain Relief PM	ACETAMINOPHEN, DIPHENHYDRAMINE HCL	DOLGENCORP, INC.	06553550-5685-f3c3-e063-6394a90aef07	2023-12-22	Warnings	Exact identifier application number: M013

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	67a190c3-7de0-4f57-be94-d6b8285e1220	12
1092189	acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SCD	67a190c3-7de0-4f57-be94-d6b8285e1220	12
1092189	APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral Tablet	SY	67a190c3-7de0-4f57-be94-d6b8285e1220	12

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
69842-956-09	69842095609	1 BOTTLE, PLASTIC in 1 CARTON (69842-956-09) > 20 TABLET in 1 BOTTLE, PLASTIC	2007-12-17	0000-00-00	No	No	Current
69842-956-13	69842095613	250 in 1 BOTTLE					Historical
69842-956-31	69842095631	80 TABLET, COATED in 1 BOTTLE, PLASTIC (69842-956-31)	2007-12-17	0000-00-00	No	No	Current