Acetaminophen

Product NDC
0363-9810
11-digit product format
003639810
Labeler code
0363
Product ID
0363-9810_59d03f57-1366-f80d-e063-6294a90a4519
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Walgreens
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-08-21
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
543f93d1-df14-0bd2-e063-6294a90a4413Available on FDA.report

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 66 of 79 · 1,561 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACETAMINOPHEN PMACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.093199be-e92a-6f60-e063-6294a90a85332024-06-14WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENRETAIL BUSINESS SERVICES , LLC.09315a3d-bb2d-4f06-e063-6294a90a3bd32024-06-14WarningsExact identifier
application number: M013
Pain Relief Regular StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION INC613bc633-0426-41a7-aea9-9ff56311b6072024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENChain Drug Marketing Associationcfaf9495-e654-4dfc-ba23-d2358c3720c42024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low DoseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.18ff2df8-ee65-4219-ad93-cf5090bfac2d2024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.9fdbaf5e-f88b-4d18-97df-0b2e8dddf3772024-06-13WarningsExact identifier
application number: M013
Aspirin 81 mg Low doseASPIRINCHAIN DRUG MARKETING ASSOCIATION, INC.bfb9af64-3195-44bf-bcf3-6b36b40d3cc72024-06-13WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENCHAIN DRUG MARKETING ASSOCIATION, INC.1ac7ed71-5afe-d09c-e063-6294a90a3b882024-06-13WarningsExact identifier
application number: M013
Pain Relief PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION, INC.3ce5bbf2-d449-464e-abeb-5c26866d1ab52024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.609948d6-0f20-4d0c-adc0-6ae72a4f2b7a2024-06-13WarningsExact identifier
application number: M013
AspirinASPIRINAAA Pharmaceutical, Inc.3f73a359-59d7-47bb-872e-914b0db719af2024-06-13WarningsExact identifier
application number: M013
topcare infants pain and feverACETAMINOPHENTopco Associates LLCf1e940ef-3cf0-4a5c-8158-156d0e5a680d2024-06-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENTrifecta Pharmaceuticals USA LLC026bf664-d598-73de-e063-6394a90a92062024-06-12WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENNuCare Pharmaceuticals,Inc.7c73fc75-af9b-177c-e053-2a91aa0ada562024-06-12WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINTopco Associates4a6a1dbb-c813-42fd-9bb8-497aec3394662024-06-11WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.fa234639-caf8-4c52-9ffe-f1c0c057ee5b2024-06-10WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.bc18590d-6481-4efe-8a3b-974f7543b7542024-06-10WarningsExact identifier
application number: M013
ASPIRINASPIRINH-E-B085b35db-62e4-38db-e063-6394a90a97632024-06-07WarningsExact identifier
application number: M013
pain and feverACETAMINOPHENMeijer Distribution Inccbfa2a25-f1e7-491e-9b67-ff2f4ba0b6cf2024-06-07WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEThe Kroger Co.5691ac45-5732-412e-abb8-2bfaac59160e2024-06-07WarningsExact identifier
application number: M013

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
0363-9810-1000363981010100 TABLET in 1 CARTON (0363-9810-10) 100 tablet2026-08-21NoNoCurrent
0363-9810-2500363981025225 TABLET in 1 CARTON (0363-9810-25) 225 tablet2026-08-21NoNoCurrent
0363-9810-500036398105050 TABLET in 1 CARTON (0363-9810-50) 50 tablet2026-08-21NoNoCurrent
0363-9810-7500363981075375 TABLET in 1 BOTTLE (0363-9810-75) 375 tablet2026-08-21NoNoCurrent