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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69842-95669842-956-09DDiscontinued by firm2026-10-21
excluded packagepackage69842-95669842-956-13DDiscontinued by firm2026-10-21

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 datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0569842-956-13d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0569842-956-09d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2669842-956-13f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2669842-956-09f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3169842-956-132ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3169842-956-092ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2869842-956-13a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2869842-956-09a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2169842-956-13cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2169842-956-09cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1069842-956-13cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1069842-956-09cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3169842-956-13302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3169842-956-09302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2069842-956-13ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2069842-956-09ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1069842-956-130efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1069842-956-090efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0869842-956-13ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0869842-956-09ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0369842-956-13367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0369842-956-09367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0969842-956-09557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0969842-956-13557ba5c1ecfa…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
IngredientStrength
ACETAMINOPHEN500 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1092189Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
67a190c3-7de0-4f57-be94-d6b8285e1220Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-956-09Acetaminophen PMExtra Strength1 in 1 CARTONTABLET, COATED112
69842-956-09Acetaminophen PMExtra Strength20 in 1 BOTTLE, PLASTICTABLET, COATED2012
69842-956-13Acetaminophen PMExtra Strength250 in 1 BOTTLETABLET, COATED25012
69842-956-31Acetaminophen PMExtra Strength80 in 1 BOTTLE, PLASTICTABLET, COATED8012

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-956ACETAMINOPHEN PM EXTRA STRENGTH (ACETAMINOPHEN, DIPHENHYDRAMINE HCL) TABLET, COATED [CVS PHARMACY]11Current NDC, Legacy NDC, 4 package rows20250327_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 28 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MAXIMUM STRENGTH NON-ASPIRIN 100ACETAMINOPHENJHK Inc dba American Safety & First Aid1d3e9948-883e-4668-9bb8-d699a283b51a2025-12-16WarningsExact identifier
application number: M013
TYLENOL EXTRA STRENGTH, TRAVEL BASIXACETAMINOPHENLil' Drug Store Products, Inc.fa951d50-b79c-4161-8c81-fcf386b0964e2025-12-15WarningsExact identifier
application number: M013
Vanquish Extra StrengthACETAMINOPHEN, ASPIRIN, AND CAFFEINEDSE Healthcare Solutions, LLCcbf12223-ef44-494b-9d3c-971dce3c5ade2025-12-15WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED8bc75bcf-01c9-41d0-a96f-77a24e3edf012025-12-15WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS40a1b354-9b2e-1cf3-e063-6394a90af1132025-12-13WarningsExact identifier
application number: M013
topcare childrens pain and feverACETAMINOPHENTopco Associates LLC911492d5-e065-4b8f-b2dc-cb6a6678d0ae2025-12-13WarningsExact identifier
application number: M013
Pain Reliever, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN TABLETLil' Drug Store Products, Inc.45c397bd-a1ff-1246-e063-6394a90ac54a2025-12-12WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45c7c11b-d627-aee8-e063-6294a90a401d2025-12-12WarningsExact identifier
application number: M013
AspirinASPIRINTOP CARE (Topco Associates LLC)d3df90be-9037-44b2-bf48-540d68a033b22025-12-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINHy-Vee98ab6fb7-c7e5-45ab-97c3-81d422f8a8432025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma33599f18-5f49-4f22-8a77-a072115763ef2025-12-11WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINVALU MERCHANDISERS COMPANY746059b3-ed18-4a81-a70e-4d758e048d8e2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain Relief PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf8820150-feec-4062-85bb-14525ddf691f2025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY005e299e-aa84-49d9-bbca-12236f865a272025-12-11WarningsExact identifier
application number: M013
Low Dose Chewable AspirinASPIRINVALU MERCHANDISERS COMPANY7d88f156-d361-4249-b70d-4bbcd5ba30b72025-12-11WarningsExact identifier
application number: M013
Enteric Coated AspirinASPIRINVALU MERCHANDISERS COMPANYcc18e8e1-652e-44da-a9d7-e56cebda55a12025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYd4c32e70-778a-4d66-b9d0-03944a5284212025-12-11WarningsExact identifier
application number: M013
adult low dose aspirinASPIRINVALU MERCHANDISERS COMPANY6fa1c707-bd42-455b-90a3-2c2a11acc6832025-12-11WarningsExact identifier
application number: M013
Extra Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANY5a80cb17-7731-4457-acd3-64cf4accf8622025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENVALU MERCHANDISERS COMPANY02e3798f-86d9-64b4-e063-6294a90a29de2025-12-11WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1092189acetaminophen 500 MG / diphenhydrAMINE HCl 25 MG Oral TabletPSN67a190c3-7de0-4f57-be94-d6b8285e122012
1092189acetaminophen 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSCD67a190c3-7de0-4f57-be94-d6b8285e122012
1092189APAP 500 MG / diphenhydramine hydrochloride 25 MG Oral TabletSY67a190c3-7de0-4f57-be94-d6b8285e122012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69842-956-09698420956091 BOTTLE, PLASTIC in 1 CARTON (69842-956-09) > 20 TABLET in 1 BOTTLE, PLASTIC2007-12-170000-00-00NoNoCurrent
69842-956-1369842095613250 in 1 BOTTLEHistorical
69842-956-316984209563180 TABLET, COATED in 1 BOTTLE, PLASTIC (69842-956-31) 2007-12-170000-00-00NoNoCurrent