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 47 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GOOD REMEDIES Extra Strength Pain Relief PM CapletACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.2d642d8e-c154-a970-e063-6294a90a03bf2025-03-14WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENDISCOUNT DRUG MART97f78c4a-9d0d-4fe1-8b2b-d5f8ab939ac42025-03-07WarningsExact identifier
application number: M013
Redicare Non-Aspirin 500mgREDICARE NON-ASPIRIN, ACETAMINOPHEN 500MGRedicare LLC2f229898-1777-732c-e063-6394a90a76bc2025-03-04Warnings, Adverse reactionsExact identifier
application number: M013
Major Extra Strength Acetaminophen LiquidACETAMINOPHENMajor Pharmaceuticals2f3af4dd-45d5-87b4-e063-6294a90ab3cc2025-02-28WarningsExact identifier
application number: M013
LOW DOSE ASPIRINASPIRINNCS HealthCare of KY, LLC dba Vangard Labsed9a71d6-a56e-416a-bb89-6d41307efc5a2025-02-27WarningsExact identifier
application number: M013
AspirinASPIRINPD-Rx Pharmaceuticals, Inc.77429b7f-78e4-42c0-8679-ae8da17488482025-02-26WarningsExact identifier
application number: M013
AeroTab Non-AspirinACETAMINOPHEN 500MG ESAero Healthcarefaa3a4ef-3c70-06ca-e053-6394a90a512d2025-02-26WarningsExact identifier
application number: M013
Bufferin Regular Strength Pain ReliefASPIRINGenomma Lab USA3543b2bf-1062-468a-a5dc-eabb2408af8c2025-02-25WarningsExact identifier
application number: M013
Calmour Childrens Acetaminophen Strips ChewableACETAMINOPHEN ORAL CHEWABLE 80 MGCalmourae47b027-4f29-45bb-a8bd-8129789328352025-02-22WarningsExact identifier
application number: M013
Infants TYLENOLACETAMINOPHENKenvue Brands LLCf9de7c2f-016b-4f40-8b5e-141ad194be972025-02-20WarningsExact identifier
application number: M013
Genexa Acetaminophen PM Extra StrengthACETAMINOPHENGenexa Inc.d82cf6f3-a291-ca2b-e053-2a95a90a6de12025-02-20WarningsExact identifier
application number: M013
Childrens AcetaminophenACETAMINOPHENAdvagen Pharma Limited8b9456c9-a56b-4748-adb8-c66d6bf072e82025-02-19WarningsExact identifier
application number: M013
Genexa Childrens AcetaminophenACETAMINOPHENGenexa Inc.d89fd9d8-d88e-3968-e053-2a95a90afc5f2025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.debfa787-7a48-48b5-94b0-6128205240322025-02-19WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPrecision Dose, Inc.b16e5dcf-b290-4ff2-a150-4b875647ec9a2025-02-19WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCbb6533e5-e6a9-488c-b8ab-a6a06e87ede92025-02-18WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLCc830320e-72ba-48ff-a4cd-250ac5650bf02025-02-18WarningsExact identifier
application number: M013
Aspirina CapletsASPIRINBayer HealthCare LLC.2e6f5ba8-8e8b-6059-e063-6394a90adcd52025-02-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.da7d95af-6583-429d-8d04-e0424f32e9ad2025-02-17WarningsExact identifier
application number: M013
GOODYS Mental AlertASPIRIN AND CAFFEINEMedtech Products Inc.31ef6d07-d314-4d09-abcd-389ba66cbcc52025-02-17WarningsExact 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