FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
41226-341
11-digit product format
412260341
Labeler code
41226
Product ID
41226-341_584661fe-3b55-4d7d-e063-6294a90acdaa
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Kroger Company
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-05-20
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
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
bc17b2e5-4828-6a2e-e053-2995a90a8c63Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-341-01ACETAMINOPHEN100 in 1 BOTTLETABLET, COATED1004
41226-341-01ACETAMINOPHEN1 in 1 CARTONTABLET, COATED14
41226-341-10ACETAMINOPHEN1 in 1 PACKAGETABLET, COATED14
41226-341-10ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5004
41226-341-15ACETAMINOPHEN150 in 1 BOTTLETABLET, COATED1504
41226-341-50ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-341ACETAMINOPHEN TABLET, COATED [KROGER COMPANY]3Current NDC, Legacy NDC, 6 package rows20240415_bc17b2e5-4828-6a2e-e053-2995a90a8c63.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 29 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Regular Strength Pain ReliefACETAMINOPHENVALU MERCHANDISERS COMPANYf7e87eac-59fb-4a72-b5c6-02953112be6a2025-12-11WarningsExact identifier
application number: M013
AspirinASPIRINVALU MERCHANDISERS COMPANY049ec1aa-66b3-9273-e063-6294a90a221b2025-12-11WarningsExact identifier
application number: M013
Aspirin 325ASPIRINWalgreen Companyf7a5d612-443c-4701-ad3b-8eb53c87bece2025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma355a094c-bed9-4959-8cf0-619f0e2461052025-12-11WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmafac4e0c6-684f-45a1-99f2-de4de4017cc82025-12-11WarningsExact identifier
application number: M013
Pain Reliever PM extra strengthACETAMINOPHEN DIPHENHYDRAMINE HCLP & L Development, LLC90eba2e8-52c3-43f5-ba93-4a520368c7f42025-12-11WarningsExact identifier
application number: M013
Midol Complete, Travel BASIXACETAMINOPHEN, CAFFEINE, AND PYRILAMINE MALEATELil' Drug Store Products, Incd6d47af8-5f8c-4c8c-a8c6-aa214ec23bca2025-12-10WarningsExact identifier
application number: M013
Tylenol PM Extra Strength, CVP HEALTHACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDELil' Drug Store Products, Inc.643371f2-e330-441e-8932-b3aec4b179d22025-12-10WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINUnited Natural Foods, Inc. dba UNFI18b79449-5c4c-41ce-9609-80f5efa0375c2025-12-09WarningsExact identifier
application number: M013
Pain ReliefACETAMINOPHENAAA Pharmaceutical, Inc.36ad34f4-4e66-f371-e063-6394a90ae76a2025-12-09WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENLIDL US LLCec543339-20ab-2cba-e053-2995a90ac7402025-12-09WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.c57c10fc-f182-4153-8974-ef359a5f5ac12025-12-09WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEHEBf7958347-4e9c-4698-8749-7ca7023ee2ba2025-12-09WarningsExact identifier
application number: M013
Pain Relief Rapid Release Gelcaps Extra StrengthACETAMINOPHENSafewayc830d1ac-c4c5-4eb1-98bb-22707cb6db912025-12-09WarningsExact identifier
application number: M013
Menstrual Pain Relief CompleteACETAMINOPHEN, PYRILAMINE MALEATE, CAFFEINEShield Pharmaceuticals Corp5efd6c61-74ed-4253-896a-e4a40bd8f25b2025-12-09WarningsExact identifier
application number: M013
Excedrin Extra Strength, TRAVEL BASIXACETAMINOPHEN, ASPIRIN, AND CAFFEINELil Drug Store Products, Inc7f0f8b3c-c226-4a3a-af46-a708f345e4f52025-12-09WarningsExact identifier
application number: M013
childrens acetaminophenACETAMINOPHENUnited Natural Foods, Inc. dba UNFIf65203a2-64f0-4138-97e4-6eab991941782025-12-09WarningsExact identifier
application number: M013
Pain Reliever PM, Extra Strength, 24-7 Life by 7-ElevenACETAMINOPHEN, DIPHENHYDRAMINE HCL TABLET, FILM COATEDLil' Drug Store Products, Inc.45735cd8-ac07-3f12-e063-6294a90a0cb22025-12-08WarningsExact identifier
application number: M013
BERKLEY AND JENSEN RAPID RELEASE ACETAMINOPHENACETAMINOPHENBJWCe27b6637-ef32-44b5-a531-b6617d02fbbf2025-12-08WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWALGREENS3f9f1740-9e8b-6a2d-e063-6294a90a67cb2025-12-06WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNbc17b2e5-4828-6a2e-e053-2995a90a8c634
198440acetaminophen 500 MG Oral TabletSCDbc17b2e5-4828-6a2e-e053-2995a90a8c634
198440APAP 500 MG Oral TabletSYbc17b2e5-4828-6a2e-e053-2995a90a8c634

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41226-341-01412260341011 BOTTLE in 1 CARTON (41226-341-01) / 100 TABLET, COATED in 1 BOTTLE1 bottle2021-06-150000-00-00NoNoCurrent
41226-341-10412260341101 BOTTLE in 1 PACKAGE (41226-341-10) / 500 BOTTLE in 1 BOTTLE / 500 TABLET, COATED in 1 BOTTLE1 bottle2021-05-200000-00-00NoNoCurrent
41226-341-1541226034115150 TABLET, COATED in 1 BOTTLE (41226-341-15) 2024-04-15NoNoCurrent
41226-341-5041226034150500 TABLET, COATED in 1 BOTTLE (41226-341-50) 2021-05-200000-00-00NoNoCurrent