FDA.reportPublic FDA data

Acetaminophen

Product NDC
67091-133
11-digit product format
670910133
Labeler code
67091
Product ID
67091-133_1cd2ed15-878d-4f79-e063-6394a90adc08
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WinCo Foods, LLC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2014-12-15
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
Brand name suffix
Extra Strength
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
c358d1dd-9fcb-4d18-9521-8f898b98a732Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67091-133-10AcetaminophenExtra Strength100 in 1 BOTTLE, PLASTICTABLET, COATED1003
67091-133-10AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED13
67091-133-50AcetaminophenExtra Strength1 in 1 CARTONTABLET, COATED13
67091-133-50AcetaminophenExtra Strength50 in 1 BOTTLE, PLASTICTABLET, COATED503

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ACETAMINOPHENACTIVE INGREDIENT362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
ACETAMINOPHENACTIVE MOIETY362O9ITL9DACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WOACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1AACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
POLYSORBATE 80INACTIVE INGREDIENT6OZP39ZG8HACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
POVIDONESINACTIVE INGREDIENTFZ989GH94EACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
SODIUM STARCH GLYCOLATE TYPE A CORNINACTIVE INGREDIENTAG9B65PV6BACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JPACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67091-133ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [WINCO FOODS, LLC]3Current NDC, Legacy NDC, 4 package rows20240710_c358d1dd-9fcb-4d18-9521-8f898b98a732.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 15 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Aspirin 81 mg Low DoseASPIRINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED23b29044-6389-42ea-839a-5351557a6ce32026-04-23WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED4a70867e-481d-4f01-9da3-d85663a1672e2026-04-23WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINUnited Natural Foods, Inc. dba UNFI07edcb31-d31d-4607-98c3-dcb1e062cc702026-04-22WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCee50c5ee-1a61-4efc-aca9-42d897d6a3b82026-04-22WarningsExact identifier
application number: M013
AspirinASPIRINCVS PHARMACY904a2b21-d911-40c3-9e4b-59543ea5be4f2026-04-22WarningsExact identifier
application number: M013
Pamprin Multi-Symptom Maximum StrengthACETAMINOPHEN, PAMABROM, PYRILAMINE MALEATEFocus Consumer Healthcare, LLC60b3286d-5698-df50-e053-2991aa0afbe22026-04-20WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENCVS PHARMACYaf6fe4a9-2d18-4fed-b952-0a7866f652512026-04-20WarningsExact identifier
application number: M013
Aspirin 81 mgASPIRINPreferred Pharmaceuticals Inc.ac7f11d2-cbfd-4610-a652-fc2f1ea41d7e2026-04-20WarningsExact identifier
application number: M013
Parry-500mg AcetaminophenACETAMINOPHENMDC PHARMACEUTICALS LIMITEDfb07ba10-3210-41bc-9310-c952118fdcf32026-04-17WarningsExact identifier
application number: M013
Aspirin NSAIDASPIRINValu Merchandisers Company0cc46a81-54c9-44b7-b384-79d25255eff22026-04-17WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINEValu Merchandisers Company99de2c41-59b0-42e7-847e-e51229c6164f2026-04-17WarningsExact identifier
application number: M013
Pain and Fever ChildrensACETAMINOPHENWalgreen Company1f3e2895-5ef7-4e6a-8d2e-b805d148f9802026-04-16WarningsExact identifier
application number: M013
Childrens TYLENOLACETAMINOPHENKenvue Brands LLCb297aff8-a08b-4d37-b168-800a56564cbd2026-04-16WarningsExact identifier
application number: M013
Childrens TylenolACETAMINOPHENKenvue Brands LLC9782fe86-d72a-4231-b1ba-d3f3b4ee49e32026-04-16WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HCLDOLGENCORP, LLC8e65478b-7a7b-416c-b8e3-23dad79f8cc12026-04-16WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINValu Merchandisers Companyc9e384e5-fa9b-4c75-b5e3-16eb8db662ef2026-04-16WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPreferred Pharmaceuticals Inc.b6abfbbb-9826-4cd6-940f-3a314480a5a52026-04-15WarningsExact identifier
application number: M013
Good Sense Pain and FeverACETAMINOPHENL. Perrigo Companyf7137fe6-582e-43a4-8302-90ca54cd1de32026-04-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCardinal Health 107, LLCe13656eb-513e-411e-bdae-35ff1ba7cfc12026-04-13WarningsExact identifier
application number: M013
CareOne AcetaminophenACETAMINOPHENAmerican Sales Companyb4f54465-3232-4685-9570-90be008765772026-04-12WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc358d1dd-9fcb-4d18-9521-8f898b98a7323
198440acetaminophen 500 MG Oral TabletSCDc358d1dd-9fcb-4d18-9521-8f898b98a7323
198440APAP 500 MG Oral TabletSYc358d1dd-9fcb-4d18-9521-8f898b98a7323

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
67091-133-10670910133101 BOTTLE, PLASTIC in 1 CARTON (67091-133-10) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-150000-00-00NoNoCurrent
67091-133-50670910133501 BOTTLE, PLASTIC in 1 CARTON (67091-133-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC2014-12-150000-00-00NoNoCurrent