Acetaminophen

Product NDC
50090-5350
11-digit product format
500905350
Labeler code
50090
Product ID
50090-5350_987708d0-122e-47da-8591-0a0ea7979aad
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
A-S Medication Solutions
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-09-12
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage50090-535050090-5350-0DDiscontinued by firm2026-10-23

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage50090-535050090-5350-0DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage50090-535050090-5350-0DDiscontinued by firmexcluded / ndc_excluded.zipf5e01cc5f278…a2eaf40c39c3…

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
c4f0f591-8501-4c6d-bf8e-ca3068ff65b5Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
50090-5350-02023-02-075427-Major
50090-5350-12023-02-075427-Major
50090-5350-02023-01-305427-Major
50090-5350-12023-01-305427-Major

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5350-0Acetaminophen100 in 1 BOTTLETABLET10013
50090-5350-1Acetaminophen42 in 1 BOTTLETABLET4213

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50090-5350-1EA - Each50090-53504268647c-bc1c-4725-83c1-6df20b553ad812024-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5350ACETAMINOPHEN TABLET [A-S MEDICATION SOLUTIONS]13Current NDC, Legacy NDC, 2 package rows20250426_c4f0f591-8501-4c6d-bf8e-ca3068ff65b5.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 63 of 79 · 1,576 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rugby AspirinASPIRINRugby Laboratories15922349-2825-45d3-95ff-c5a2879ec2252024-09-12WarningsExact identifier
application number: M013
rexall pain reliefACETAMINOPHENDolgencorp, LLC9783cf37-3a2b-4ca1-b4eb-6d6ba047a3252024-09-12WarningsExact identifier
application number: M013
leader aspirinASPIRINCardinal Health 110, LLC. dba Leaderb8cc9f78-a292-40eb-819d-bd80a552628f2024-09-11WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENH E B3258ef39-c36e-4a97-8631-89b8d4caf0582024-09-11WarningsExact identifier
application number: M013
Acetaminophen and Diphenhydramine hydrochlorideACETAMINOPHEN AND DIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANYb9b86755-63ad-e25a-e053-2995a90ad7472024-09-10WarningsExact identifier
application number: M013
aspirinASPIRINPublix Super Markets Inc88b0d897-b93f-42c3-88d0-784dd6c555e42024-09-10WarningsExact identifier
application number: M013
good neighbor pharmacy aspirinASPIRINAmerisource Bergen820ceaee-2b49-4204-8ebb-d683d9b62e142024-09-10WarningsExact identifier
application number: M013
Parents Choice Infants Pain and FeverACETAMINOPHENWal-Mart Stores Inc30a51b90-a565-4e38-82ee-b5af297629772024-09-10WarningsExact identifier
application number: M013
equate aspirin chewableASPIRINWal-Mart Stores Inc9147c0ce-fcdb-457c-b9f5-e4edd66e91d02024-09-10WarningsExact identifier
application number: M013
signature care infants pain reliefACETAMINOPHENSafeway236df05a-cf11-42f3-a347-b54f5113680c2024-09-10WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENMeijer Distribution Incd2759fa6-59cd-417e-8761-d2b129aad8b82024-09-09WarningsExact identifier
application number: M013
M-PAPACETAMINOPHENBryant Ranch Prepackd344479b-80c1-4592-acc8-3f12690c839c2024-09-06WarningsExact identifier
application number: M013
signature care childrens pain reliefACETAMINOPHENSafewayfccb5aca-5707-491f-beb4-08f5689191692024-09-06WarningsExact identifier
application number: M013
HEADACHE RELIEFACETAMINOPHEN-ASPIRIN-CAFFEINETARGET CORPORATION8e953cef-135e-f1aa-e053-2995a90aaa8b2024-09-05WarningsExact identifier
application number: M013
AspirinASPIRINCVS Pharmacy5cf74d72-c818-400a-9279-87e209efeb152024-09-05WarningsExact identifier
application number: M013
ASPIRNASPIRINHF Acquisition Co LLC, DBA HealthFirst21524b42-f8fd-673c-e063-6294a90a22e82024-09-04WarningsExact identifier
application number: M013
Topcare AspirinASPIRINTopco Associates LLC6615bf85-1f79-4d21-91f9-4248c3cf9b382024-09-04WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENTARGET CORPORATION80da2582-1a20-e111-e053-2991aa0acf322024-09-03WarningsExact identifier
application number: M013
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNc4f0f591-8501-4c6d-bf8e-ca3068ff65b513
198440acetaminophen 500 MG Oral TabletSCDc4f0f591-8501-4c6d-bf8e-ca3068ff65b513
198440APAP 500 MG Oral TabletSYc4f0f591-8501-4c6d-bf8e-ca3068ff65b513

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50090-5350-050090535000100 TABLET in 1 BOTTLE (50090-5350-0) 100 tablet2020-11-100000-00-00NoNoCurrent
50090-5350-15009053500142 TABLET in 1 BOTTLE (50090-5350-1) 42 tablet2021-12-080000-00-00NoNoCurrent