FDA.reportPublic FDA data

acetaminophen

Product NDC
68196-919
11-digit product format
681960919
Labeler code
68196
Product ID
68196-919_2d2a7fc6-966a-4716-a3af-98e09b1dc3a7
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Sam's West Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-05-10
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2027-12-31
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
Brand name suffix
extra strength
Listing expiration
2027-12-31

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
dd99efd0-4ca4-4dc6-a940-bebd17ac8f8dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68196-919-05acetaminophenextra strength400 in 1 BOTTLE, PLASTICTABLET, COATED40013

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH48ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
D&C RED NO. 33INACTIVE INGREDIENT9DBA0SBB0LACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
GELATININACTIVE INGREDIENT2G86QN327LACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET [SAM'S WEST INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68196-919ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAM'S WEST INC]12Current NDC, Legacy NDC, 1 package rows20241027_dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d.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 45 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain ReliefACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1c083e29-8732-4ecd-ab4b-9038acbd0b9d2025-05-22WarningsExact identifier
application number: M013
TYLENOL For Children Plus AdultsACETAMINOPHENKenvue Brands LLC5bb8ef99-a94b-49f9-89f9-cd1ce0a47a422025-05-21WarningsExact identifier
application number: M013
Children AcetaminophenACETAMINOPHENAARNA USA INC.25bcb9d5-f388-4ae7-8037-970ffe8d17f02025-05-16WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENHF Acquisition Co LLC, DBA HealthFirst35478de8-50d0-5d0a-e063-6294a90a88ba2025-05-16WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.95f4b628-6d35-4f6b-91f9-b2d117f8e8212025-05-16WarningsExact identifier
application number: M013
good neighbor pharmacy childrens pain and feverACETAMINOPHENAmerisource Bergen268a789b-8f31-4739-9777-523249cac3262025-05-13WarningsExact identifier
application number: M013
ASPIRIN LOW DOSEASPIRIN LOW DOSEAARNA USA INC.347edc8f-6391-b75e-e063-6394a90a1cf52025-05-06WarningsExact identifier
application number: M013
Good Neighbor Pharmacy Infants Pain and FeverACETAMINOPHENAmerisource Bergen2cfbb8ad-3ecb-432b-9eb4-16c51bf23bb22025-05-06WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.34157f6a-3031-4388-e063-6394a90a670f2025-05-01WarningsExact identifier
application number: M013
ASPIRINASPIRINHF Acquisition Co LLC, DBA HealthFirst2553d0cb-3f5c-7ea0-e063-6294a90a3cd42025-05-01Warnings, Adverse reactionsExact identifier
application number: M013
Aspirin 81mg Enteric CoatedASPIRINAdvanced Rx LLC606067bb-b07f-444e-9465-d1e187735f3a2025-05-01WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENAARNA USA INC.33f0e822-28af-9bb2-e063-6294a90a51752025-04-29WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENGeri-Care Pharmaceutical Corp27fcca07-f845-77fe-e063-6394a90aa2f82025-04-24WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENA-S Medication Solutions46a6bbb9-ccd1-47a8-9e58-485f71f570632025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutions061c91d5-5aa8-4556-a344-197b7e8a10b82025-04-24WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENA-S Medication Solutionsc4f0f591-8501-4c6d-bf8e-ca3068ff65b52025-04-24WarningsExact identifier
application number: M013
Extra Strength No-PainACETAMINOPHENSafrel Pharmaceuticals, LLC.873f01dd-0701-5fd3-e053-2a95a90a64632025-04-23WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENChain Drug Consortium60d4b392-6ed0-4115-8154-24eaf72504a52025-04-16WarningsExact identifier
application number: M013
Premsyn pms Premenstrual Pain ReliefACETAMINOPHEN AND PAMABROM AND PYRILAMINE MALEATEFocus Consumer Healthcare, LLC5b6f6260-69ae-cfeb-e053-2a91aa0a6b492025-04-14WarningsExact identifier
application number: M013
BackAid MaxACETAMINOPHEN, PAMABROMKobayashi Healthcare International, Inc.fb9a5647-b7c9-4820-b148-91060e34cb832025-04-14WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d13
198440acetaminophen 500 MG Oral TabletSCDdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d13
198440APAP 500 MG Oral TabletSYdd99efd0-4ca4-4dc6-a940-bebd17ac8f8d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
68196-919-0568196091905400 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-919-05) 2004-05-100000-00-00NoNoCurrent