FDA.reportPublic FDA data

Acetaminophen

Product NDC
69848-003
Requested package NDC
69848-003-24
11-digit product format
698480003
Labeler code
69848
Product ID
69848-003_468e5f4e-8bc6-6b97-e063-6294a90a0166
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
Granules USA, Inc
Application
M013
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-07-01
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 · 1 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
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage69848-00369848-003-24IInactivated by FDAexcluded / ndc_excluded.zipe2bbac7714bc…27bdfed8d636…

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
a1255f60-b9c6-9a95-e053-2995a90a9e80Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
69848-003-102020-12-30EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-12-30EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-12-30EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-102020-09-27EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-09-27EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-09-27EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-102020-09-25EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-09-25EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-09-25EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-102020-07-22EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-172020-07-22EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS
69848-003-242020-07-22EXTRA STRENGTH Pain Relief Acetaminophen USP,500 mg Pain Reliever/Fever Reducer FOR ADULTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69848-003-10Acetaminophen100 in 1 BOTTLETABLET1008
69848-003-17Acetaminophen175 in 1 BOTTLETABLET1758
69848-003-24Acetaminophen24 in 1 BOTTLETABLET248

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69848-003ACETAMINOPHEN TABLET [GRANULES USA, INC]7Current NDC, Legacy NDC, 3 package rows20241218_a1255f60-b9c6-9a95-e053-2995a90a9e80.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 40 of 79 · 1,570 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
pain reliefACETAMINOPHENSafeway0e0a73f9-8c18-41fd-812e-8be20287e77a2025-08-26WarningsExact identifier
application number: M013
Aspirin Low Dose Safety CoatedASPIRINBJWC (Berkley & Jensen / BJ's)577035a5-88ab-431c-8598-7a19dd633fe92025-08-26WarningsExact identifier
application number: M013
Topcare Pain ReliefACETAMINOPHENSixarp, LLC2e20be17-2b6c-1a07-e063-6394a90acdd32025-08-25WarningsExact identifier
application number: M013
Low Dose AspirinASPIRINBJWC (Berkley & Jensen / BJ's)2f32b096-d29a-c7c7-e063-6294a90a2bbe2025-08-22WarningsExact identifier
application number: M013
Medique Medi SeltzerASPIRIN, CITRIC ACID, SODIUM BICARBONATEUnifirst First Aid Corporation528da9d9-2a52-4c16-b7b2-61b3eee1abea2025-08-19WarningsExact identifier
application number: M013
pain reliefACETAMINOPHENPublix Super Markets Inc6b691dc1-09e4-46d3-b199-8917e42848a62025-08-19WarningsExact identifier
application number: M013
Pain Relief Extra StrengthACETAMINOPHENP & L Development, LLC59eb14a5-40b0-4331-beb5-7166e6cdf4112025-08-18WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENPAI Holdings, LLC dba PAI Pharmacaf5daea-409e-5dd2-e053-2995a90acb122025-08-18WarningsExact identifier
application number: M013
Dr Simi Pain Relief 100ACETAMINOPHENFarmacias De Similares TX LLC3c42e48d-cdb2-eb74-e063-6394a90a29402025-08-13WarningsExact identifier
application number: M013
Dr Simi Pain ReliefACETAMINOPHENFarmacias De Similares TX LLC3c477d33-a8c2-d39f-e063-6294a90ac5f02025-08-13WarningsExact identifier
application number: M013
Headache Relief Extra StrengthACETAMINOPHEN, ASPIRIN AND CAFFEINECHAIN DRUG MARKETING ASSOCIATION INC4005f8dd-3050-4590-8703-6997444e8df32025-08-13WarningsExact identifier
application number: M013
good sense headache reliefACETAMINOPHEN, ASPIRIN, CAFFEINEL. Perrigo Company4cae0580-7ee3-4f38-8d13-79c7d7615f8f2025-08-12WarningsExact identifier
application number: M013
TYLENOL Extra StrengthACETAMINOPHENKenvue Brands LLC3bb7dc60-97b2-1291-e063-6294a90a26d92025-08-12WarningsExact identifier
application number: M013
Dr Simi Pain Reliever PMACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDEFarmacias De Similares TX LLC3c19ad99-6e0f-3116-e063-6394a90a914c2025-08-11WarningsExact identifier
application number: M013
good sense pain reliefACETAMINOPHENNuCare Pharmaceuticals,Inc.3c1f505d-0319-a179-e063-6294a90a0b172025-08-11WarningsExact identifier
application number: M013
AspirinASPIRINPROSTAT FIRST AID3bdb9d89-9000-69f9-e063-6294a90a0c972025-08-08WarningsExact identifier
application number: M013
AcetaminophenACETAMINOPHENProstat First Aid3bdbea6a-3f11-9142-e063-6294a90a20ea2025-08-08WarningsExact identifier
application number: M013
Aspi-CorASPIRINL.N.K. International, Inc.9f919a48-ffd8-49fa-b6fd-ec71cc12e64b2025-08-08WarningsExact identifier
application number: M013
Aspirin Low DoseASPIRINA-S Medication Solutions8575ef9d-2eae-412a-a252-82b03f4d52752025-08-08WarningsExact identifier
application number: M013
AspirinASPIRINA-S Medication Solutions7a91b1df-8d6d-4205-9822-bc4d800555f72025-08-08WarningsExact identifier
application number: M013

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNa1255f60-b9c6-9a95-e053-2995a90a9e808
198440acetaminophen 500 MG Oral TabletSCDa1255f60-b9c6-9a95-e053-2995a90a9e808
198440APAP 500 MG Oral TabletSYa1255f60-b9c6-9a95-e053-2995a90a9e808

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69848-003-246984800032424 TABLET in 1 BOTTLE (69848-003-24) 24 tablet2019-07-010000-00-00NoNoCurrent