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 64 of 79 · 1,579 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Neighbor Pharmacy AspirinASPIRINAmerisource Bergend9db6659-6afc-431b-ae05-c941775e63662024-09-01WarningsExact identifier
application number: M013
Topcare AspirinASPIRINTopco Associates LLC8133c3fc-97ce-46b4-8580-7da9f09f622b2024-08-30WarningsExact identifier
application number: M013
Tylenol PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc639f4e01-9723-a619-e053-2991aa0a549a2024-08-27WarningsExact identifier
application number: M013
Extra Strength Acetaminohpen Adult Rapid Burst CherryACETAMINOPHENMajor Pharmaceuticals9e7543d9-6249-45b5-b67d-c1b439423b9c2024-08-27WarningsExact identifier
application number: M013
aspirinASPIRINMajor Pharmaceuticals58684138-04d1-44a4-bc52-c5b85d93d7a62024-08-23WarningsExact identifier
application number: M013
Up and Up childrens acetaminophenACETAMINOPHENTarget Corporation9c3ba4dd-f51b-46ce-91b8-8b617c7b78da2024-08-23WarningsExact identifier
application number: M013
CVS Effervescent Pain RelieverASPIRINCVS PHARMACY0761147f-1337-606e-e063-6394a90abd5d2024-08-22WarningsExact identifier
application number: M013
pain relieverACETAMINOPHENWalgreen Company8255900a-2d58-4261-8df7-f283198835702024-08-21WarningsExact identifier
application number: M013
Pain and FeverACETAMINOPHENH E B86a072a9-c3b8-47f7-8598-d66e3d30e7622024-08-21WarningsExact identifier
application number: M013
Childrens Pain and FeverACETAMINOPHENKroger Companyd965eba0-b268-41b2-8e02-5f6d769a44d72024-08-18WarningsExact identifier
application number: M013
equate pain and fever childrensACETAMINOPHENWal-Mart Stores Incea68d735-c677-4280-a3a3-ae3eb5ff74622024-08-17WarningsExact identifier
application number: M013
childrens pain and feverACETAMINOPHENCVS Pharmacyfac408f0-ebb6-4c72-88ee-2ba85867859c2024-08-16WarningsExact identifier
application number: M013
Regular Strength Pain ReliefACETAMINOPHENBryant Ranch Prepack3f0c32b1-2c54-4ca3-9759-9e5dd9d7ad242024-08-14WarningsExact identifier
application number: M013
Quality Choice Effervescent Antacid and Pain Relief - Extra StrengthASPIRIN, ANHYDROUS CITRIC ACID, SODIUM BICARBONATEChain Drug Marketing Association1f926637-a61c-8eb7-e063-6394a90a65022024-08-13WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharma6ec12573-03d6-40c1-9945-d345b401e0622024-08-12WarningsExact identifier
application number: M013
CareOne Infants AcetaminophenACETAMINOPHENAmerican Sales Companyeacee273-abd7-4ea4-bcaa-7f74abcc9feb2024-08-07WarningsExact identifier
application number: M013
infants pain and feverACETAMINOPHENKroger Company7dbe284a-c0d5-4ac4-8445-611610f3c0fb2024-08-02WarningsExact identifier
application number: M013
Dollar General Effervescent Pain RelieverASPIRINDolgencorp, Inc1deab362-a325-3a00-e063-6294a90a9acd2024-08-01WarningsExact identifier
application number: M013
Acetaminophen Extra StrengthACETAMINOPHENFSA STORE INC.1cd6a3e6-1376-0b7b-e063-6394a90af3d12024-07-30WarningsExact identifier
application number: M013
pain relief pm extra strengthACETAMINOPHEN, DIPHENHYDRAMINE HCLPublix Super Markets Inc42d271b7-b45f-4497-8de2-4e05b4bebfa92024-07-17WarningsExact 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