FDA.reportPublic FDA data

ACETAMINOPHEN 500 MG

Product NDC
50090-7961
11-digit product format
500907961
Labeler code
50090
Product ID
50090-7961_50c13130-05da-459d-b94d-d930f6599768
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
2015-11-01
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 500 MG
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
92559d65-f5e2-4054-9763-b9c560452dabAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-7961-0ACETAMINOPHEN 500 MG14 in 1 BOTTLETABLET141

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 36 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AcetaminophenACETAMINOPHENPD-Rx Pharmaceuticals, Inc.3f96aeb1-a533-4d36-9a1f-62fc094b67542025-10-08WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN, CAFFEINEWalgreensf2eb9575-d527-44c7-aa5e-efabfd9a02782025-10-07WarningsExact identifier
application number: M013
Acetaminophen PM Extra StrengthACETAMINOPHEN, DIPHENHYDRAMINE HCLCHAIN DRUG MARKETING ASSOCIATION INCbbc704e5-79f6-4c72-846b-cc30c5c43cb42025-10-07WarningsExact identifier
application number: M013
Aspirin Enteric CoatedASPIRINCHAIN DRUG MARKETING ASSOCIATION INCf1ce15a3-9824-4eb5-910a-39078165f3852025-10-07WarningsExact identifier
application number: M013
BupropiDexDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.90cc9bcd-7891-4324-a1f4-f6df7a0457e02025-10-06WarningsExact identifier
application number: M013
DextabsDEXTROMETHORPHAN HYDROBROMIDEDXM Pharmacuetical, Inc.71b567df-844a-4563-b85a-f4592233f37d2025-10-06WarningsExact identifier
application number: M013
Acetaminophen, Aspirin and CaffeineACETAMINOPHEN, ASPIRIN AND CAFFEINERising Pharma Holdings, Inc.50f72713-50f5-4bab-9e96-b9fa73c9df1f2025-10-06WarningsExact identifier
application number: M013
OneSsip Acetaminophen Oral Suspension Bubble Gum 5 mLACETAMINOPHEN 160 MG / 5 MLMEDWISE LIFESCIENCES INC.40507559-aee4-a603-e063-6394a90afc4f2025-10-04WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENNuCare Pharmaceuticals,Inc.004c39cd-b4f4-1cae-e063-6394a90a06972025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)43573e35-6776-446e-aa28-75c8edc5b98d2025-10-03WarningsExact identifier
application number: M013
Pain RelieverACETAMINOPHENFamily Dollar (FAMILY WELLNESS)f8e5fab4-1212-4c60-a160-9b782f76a1982025-10-03WarningsExact identifier
application number: M013
CVS AcetaminophenACETAMINOPHENCVS Pharmacy3d71a0aa-5e03-0bdc-e063-6294a90a66342025-10-02WarningsExact identifier
application number: M013
ACETAMINOPHENACETAMINOPHENBryant Ranch Prepack8e40f8f1-03c5-444b-8b5e-4532c3146e472025-10-02WarningsExact identifier
application number: M013
ASPIRIN 325 MG ECASPIRINProficient Rx LP9f9355f7-024a-4adc-bb4c-2d9c0dd0cb772025-10-01WarningsExact identifier
application number: M013
Cabinet Pain Reliever and Fever Reducer Refill AcetaminophenACETAMINOPHENCabinet Health P.B.C.2744f082-adfd-4dfc-a87d-ed8c0d84a4472025-10-01WarningsExact identifier
application number: M013
ASPIRINASPIRINMarc Glassman, Inc.14cb1d2d-95b8-447e-8d79-e6ec82c0e4312025-10-01WarningsExact identifier
application number: M013
ACETAMINOPHEN 325 MGACETAMINOPHENProficient Rx LP6794830a-7856-464d-84be-c8b253cf41ac2025-10-01WarningsExact identifier
application number: M013
Enteric Coated Aspirin Regular StrengthASPIRINBryant Ranch Prepacke05140fa-9766-4f97-bffc-e36a01b9d38f2025-10-01WarningsExact identifier
application number: M013
Acetaminophen gelcapsACETAMINOPHENTARGET CORPORATION2ea1931e-334e-a551-e063-6394a90a03b92025-09-29WarningsExact identifier
application number: M013
acetaminophenACETAMINOPHENTARGET CORPORATION8ed1d1f5-fe4a-5fd8-e053-2a95a90a90fb2025-09-29WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSN92559d65-f5e2-4054-9763-b9c560452dab1
198440acetaminophen 500 MG Oral TabletSCD92559d65-f5e2-4054-9763-b9c560452dab1
198440APAP 500 MG Oral TabletSY92559d65-f5e2-4054-9763-b9c560452dab1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50090-7961-05009079610014 TABLET in 1 BOTTLE (50090-7961-0) 14 tablet2026-05-11NoNoCurrent