FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
49035-755
11-digit product format
490350755
Labeler code
49035
Product ID
49035-755_2b6c0fa2-3f13-50df-e063-6294a90a044d
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET, COATED
Route
ORAL
Labeler
WAL-MART STORES INC
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-03
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage49035-755-88ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage49035-755-880efc9e666f02…f202fb6c5f17…

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
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
8f221fdb-8138-c1a8-e053-2995a90a29c2Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
49035-755-50ACETAMINOPHEN500 in 1 BOTTLETABLET, COATED5004
49035-755-88ACETAMINOPHEN1000 in 1 PACKAGETABLET, COATED10004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-755ACETAMINOPHEN TABLET, COATED [WAL-MART STORES INC]4Current NDC, Legacy NDC, 2 package rows20250121_8f221fdb-8138-c1a8-e053-2995a90a29c2.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 7 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
INFANTS PAIN AND FEVERACETAMINOPHENAmazon.com Services LLC112076c4-cac2-45ab-9c77-5573edae71802026-07-10WarningsExact identifier
application number: M013
AspirinASPIRINWal-Mart Stores Inc8ae16aa2-54bc-4c1a-aa36-93524199a67b2026-07-09WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENWildman Business Group943c8f49-e65e-40bc-b364-3274df4d21a22026-07-09WarningsExact identifier
application number: M013
Aspirin Regular StrengthASPIRINFOODHOLD U.S.A., LLC9e09b4fb-e015-45ea-8b1c-27faf65572aa2026-07-09WarningsExact identifier
application number: M013
Tension Headache ReliefACETAMINOPHEN, CAFFEINEWalgreen Companyf13fb7e9-50ea-4e2c-a442-38b1b5b315d72026-07-09WarningsExact identifier
application number: M013
Acetaminophen 500 Pyrilamine Maleate 15 and Caffeine 60ACETAMINOPHEN 500MG PYRILAMINE MALEATE 15MG AND CAFFEINE 60MG TABLETSHealth Pharma USA LLC34eb8a9b-d0ee-13e8-e063-6294a90a2fef2026-07-08WarningsExact identifier
application number: M013
Acetaminophen 250 mg Aspirin 250 mg Caffeine 65 mgACETAMINOPHEN 250 MG ASPIRIN 250 MG CAFFEINE 65 MGHealth Pharma USA LLC3590d417-272b-ae4d-e063-6394a90a5dc62026-07-08WarningsExact identifier
application number: M013
GOODMEDS EXTRA STRENGTH PAIN RELIEF ACETAMINOPHENACETAMINOPHENCabinet Health P.B.C.88884253-5a79-4ac1-b8ce-03966d8b509d2026-07-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHealth Pharma USA LLC671adabe-5f82-4599-a133-3f67ccb340792026-07-07WarningsExact identifier
application number: M013
Pain Reliever PlusACETAMINOPHEN, ASPIRIN, CAFFEINERugby Laboratoriesc3df1652-96a8-6043-e053-2995a90a2d262026-07-07WarningsExact identifier
application number: M013
Rapidol AspirinASPIRINPharmadel LLC00d9ab0d-ff25-784f-e063-6294a90a84972026-07-06WarningsExact identifier
application number: M013
AspirinASPIRINTrifecta Pharmaceuticals USA LLC227cefca-acc4-41d0-e063-6394a90a35b92026-07-06WarningsExact identifier
application number: M013
Extra Strength Pain AidACETAMINOPHEN, ASPIRIN, CAFFEINEHi-Tech Nutaceuticals, LLCa39e4b99-700d-0f5c-e053-2a95a90a6bd32026-07-06WarningsExact identifier
application number: M013
Nighttime Sleep AidACETAMINOPHEN, DIPHENHYDRAMINEHi-Tech Nutraceuticals, LLCa39e2bd6-3d0a-642b-e053-2995a90a42a02026-07-06WarningsExact identifier
application number: M013
Extra Strength AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa36be487-7a36-550f-e053-2a95a90a95c12026-07-06WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENHi-Tech Nutraceuticals, LLCa39c524e-c131-d7fb-e053-2995a90a785b2026-07-06WarningsExact identifier
application number: M013
PAIN RELIEVERASPIRIN 81 MGHealth Pharma USA, LLCd60aed37-3a9e-46d1-e053-2995a90a1d1f2026-07-06WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d0dceb-c9a9-778e-e063-6294a90a2ad72026-07-04WarningsExact identifier
application number: M013
Bayer Genuine AspirinASPIRINSelect Consumer Group3ca776c2-47ed-5107-e063-6394a90ac5df2026-07-03WarningsExact identifier
application number: M013
AspirinASPIRINRugby Laboratoriesf7ca9f4a-f8ef-46d2-9536-b69541e6653d2026-07-02WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN8f221fdb-8138-c1a8-e053-2995a90a29c24
198440acetaminophen 500 MG Oral TabletSCD8f221fdb-8138-c1a8-e053-2995a90a29c24
198440APAP 500 MG Oral TabletSY8f221fdb-8138-c1a8-e053-2995a90a29c24

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-755-5049035075550500 in 1 BOTTLEHistorical
49035-755-88490350755881000 BOTTLE in 1 PACKAGE (49035-755-88) / 500 TABLET, COATED in 1 BOTTLE (49035-755-50) 1000 bottle2020-01-030000-00-00NoNoCurrent