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 11 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens MapapACETAMINOPHENMajor Pharmaceuticalsefec6af2-8b26-47f6-88c8-b0a6d69a2d7d2026-06-03WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFIae3114c3-8cfe-4b81-8ac7-c281fe68b4622026-06-03WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENCOSTCO WHOLESALE CORPORATION3745aa18-a711-43ed-9bc4-1f087b3c53c02026-06-03WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3f653262-b931-7d42-e063-6394a90adddd2026-06-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENWalgreen Company0b1bef50-7957-4ea1-9ae3-91f59ea2dbb42026-06-03WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLWALMART INC.42310898-cf3a-4ffb-88bb-b8b84449156e2026-06-02WarningsExact identifier
application number: M013
PAIN RELIEFACETAMINOPHENMeijer, Inc.1319bab8-8f17-44fb-9d91-099b0ba38a8d2026-06-01WarningsExact identifier
application number: M013
Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HCLFamily Dollar (FAMILY WELLNESS)7a98d4d9-54e2-45c1-a76a-7f1907566e952026-06-01WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENTIME CAP LABORATORIES, INC.58840cf4-aceb-c7cf-e063-6294a90a5ff42026-06-01WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENCVS Pharmacy832acd72-1dda-4490-978f-5f31748942df2026-06-01WarningsExact identifier
application number: M013
Acetaminophen PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEMajor Pharmaceuticals786dbcd5-f5c2-4491-e053-2991aa0a34372026-05-29WarningsExact identifier
application number: M013
Back and Body Extra StrengthASPIRIN, CAFFEINEMeijer Distribution Ince513f2d9-d591-4790-a117-6176ce2279dc2026-05-29WarningsExact identifier
application number: M013
Chewable Acetaminophen ChildrensACETAMINOPHENCardinal Health 110, LLC. DBA Leader5460a4b7-5da3-4fc2-a565-0b0dd11bbf442026-05-29WarningsExact identifier
application number: M013
Extra Strength Mini Softgels Pain RelieverACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDf55d3663-7007-41cd-ae2d-5aca6311be812026-05-28WarningsExact identifier
application number: M013
Genexa Kids Pain and FeverACETAMINOPHENGenexa Inc.5130c695-a80e-2dd3-e063-6294a90a404f2026-05-28WarningsExact identifier
application number: M013
TYLENOL Regular StrengthACETAMINOPHENKenvue Brands LLC1622f694-4d63-4c56-8737-fae31f0ecfb72026-05-27WarningsExact identifier
application number: M013
INFANTS Pain and FeverACETAMINOPHENAurohealth LLC257436e1-e0f3-4a87-bffe-4f176b836caf2026-05-27WarningsExact identifier
application number: M013
Infants Pain and FeverACETAMINOPHENAurohealth LLC6509a545-0036-460a-8f0d-b31caae178552026-05-27WarningsExact identifier
application number: M013
Alka-Seltzer OriginalANHYDROUS CITRIC ACID, ASPIRIN, AND SODIUM BICARBONATESelect Consumer Group3ca80d74-1e8b-49d9-e063-6394a90a43122026-05-24WarningsExact identifier
application number: M013
Pain and Fever Chewables ChildrensACETAMINOPHENCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDbad8ac0a-518d-4639-9b92-a39e0d4372382026-05-22WarningsExact 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