FDA.reportPublic FDA data

Acetaminophen

Product NDC
69842-295
11-digit product format
698420295
Labeler code
69842
Product ID
69842-295_46546de7-075e-b09c-e063-6294a90ae4b3
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
CVS PHARMACY, INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-03
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
198440Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b1307d52-10e6-46e1-e053-2995a90a03b6Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-295-05Acetaminophen50 in 1 BOTTLETABLET509
69842-295-10Acetaminophen100 in 1 BOTTLETABLET1009
69842-295-15Acetaminophen150 in 1 BOTTLETABLET1509
69842-295-21Acetaminophen225 in 1 BOTTLETABLET2259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-295ACETAMINOPHEN TABLET [CVS PHARMACY, INC]7Current NDC, 4 package rows20250504_b1307d52-10e6-46e1-e053-2995a90a03b6.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 72 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Excedrin Extra Strength Pain RelieverACETAMINOPHEN, ASPIRIN (NSAID), AND CAFFEINEHaleon US Holdings LLC691b754c-bafc-47e2-a322-cf56245c01f62024-03-14WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS PHARMACY, INCfdc80b2a-d7c1-4b3d-9a9b-28182c6320de2024-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENQUALITY CHOICE (Chain Drug Marketing Association)2cde052d-22a4-470f-8d6a-7c17061b8ac82024-03-14WarningsExact identifier
application number: M013
Excedrin Tension HeadacheACETAMINOPHEN, CAFFEINEHaleon US Holdings LLC12c074d1-81ac-47d2-8747-b018cda0058a2024-03-13WarningsExact identifier
application number: M013
Menstrual CompleteACETAMINOPHEN, CAFFEINE, PYRILAMINE MALEATEStrive Pharmaceuticals Inc.78c12459-3b27-4ed0-943d-520794eb438d2024-03-07WarningsExact identifier
application number: M013
Pain Reliever fever Reducer Extra StrengthACETAMINOPHENCVS Pharmacy7b5263ad-01b7-4fc5-9384-4da8efe89e352024-03-06WarningsExact identifier
application number: M013
Excedrin Extra Strength GeltabsACETAMINOPHEN, ASPRIN, CAFFEINEHaleon US Holdings LLC11a8439b-0159-4351-b0f5-fe7fad6a33c02024-03-05WarningsExact identifier
application number: M013
Winco Foods Effervescent Pain ReliefASPIRINWinco Foods, LLC128afdd7-a9d1-8957-e063-6294a90af5692024-03-05WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINCare One (Retail Business Services, LLC.)6659e103-fa03-4de0-af42-d2fbd548a87c2024-03-05WarningsExact identifier
application number: M013
Dolex Children Pain and FeverACETAMINOPHENPharmadel LLCf9158463-aeb1-5de0-e053-6294a90a748b2024-03-04WarningsExact identifier
application number: M013
SEDALMEX FORTEACETAMINOPHEN, ASPIRIN, CAFFEINEBelmora LLC33b3508e-4caa-4d05-9b15-cb82a2ee2d4d2024-02-28WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAMERISOURCE BERGEN2b923a97-836c-4dac-a8c0-3047a35fb62e2024-02-23WarningsExact identifier
application number: M013
Pain Reliever PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLBJWC (Berkley & Jensen / BJ's)b20a08f3-c9c0-4bd9-8ce0-acb932b5bb862024-02-22WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepack31a41976-7f65-42d7-acf5-de9c2c5ca58e2024-02-20WarningsExact identifier
application number: M013
Publix Fast Relief Effervescent - Original FlavorASPIRINPUBLIX SUPER MARKETS INC.0a342f72-45fd-3e12-e063-6394a90ae33e2024-02-16WarningsExact identifier
application number: M013
Equaline Effervescent Pain RelieverASPIRINUNITED NATURAL FOODS, INC. DBA UNFI0761299a-e913-7665-e063-6394a90a60032024-02-16WarningsExact identifier
application number: M013
TopCare Effervescent Pain ReliefASPIRINTOPCO ASSOCIATES LLC075f36e1-110c-e839-e063-6294a90a89d72024-02-16WarningsExact identifier
application number: M013
Extra Strength Pain RelieverACETAMINOPHENINGLES MARKETS, INC.115d0b4f-6f0f-79a9-e063-6394a90ab18a2024-02-14WarningsExact identifier
application number: M013
PANADOLACETAMINOPHENHaleon US Holdings LLCe1799765-c247-42b4-ad6a-8ba7d136abf22024-02-06WarningsExact identifier
application number: M013
Panadol Cold and Flu NonDrowsyACETAMINOPHEN AND PHENYLEPRINE HCLHaleon US Holdings LLCf626ab17-01c9-4493-ba9e-0c8c111463842024-02-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNb1307d52-10e6-46e1-e053-2995a90a03b69
198440acetaminophen 500 MG Oral TabletSCDb1307d52-10e6-46e1-e053-2995a90a03b69
198440APAP 500 MG Oral TabletSYb1307d52-10e6-46e1-e053-2995a90a03b69

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69842-295-056984202950550 TABLET in 1 BOTTLE (69842-295-05) 50 tablet2023-03-03NoNoCurrent
69842-295-1069842029510100 TABLET in 1 BOTTLE (69842-295-10) 100 tablet2023-03-03NoNoCurrent
69842-295-1569842029515150 TABLET in 1 BOTTLE (69842-295-15) 150 tablet2023-03-03NoNoCurrent
69842-295-2169842029521225 TABLET in 1 BOTTLE (69842-295-21) 225 tablet2023-03-03NoNoCurrent