FDA.reportPublic FDA data

ACETAMINOPHEN

Product NDC
68071-4118
Requested package NDC
68071-4118-3
11-digit product format
680714118
Labeler code
68071
Product ID
68071-4118_d6070f38-515c-049e-e053-2a95a90aade6
Type
HUMAN OTC DRUG
Nonproprietary name
ACETAMINOPHEN
Dosage form
TABLET
Route
ORAL
Labeler
NuCare Pharmaceuticals,Inc.
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2006-03-27
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
325 mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

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 packagepackage68071-411868071-4118-3IInactivated by FDA2026-10-05

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 · 11 matching rows.

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

Captured / source date, Code, Status table
Captured / source dateCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2020-06-10 20:45 UTC · source 2020-06-10IInactivated by FDA9bebd1f3094a…5416666fcb17…
2019-12-08 06:16 UTC · source 2019-12-05YUnknown FDA exclusion code: Y110d247fa046…a55b01930146…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
68071-4118-22025-01-30Drug Facts
68071-4118-32025-01-30Drug Facts
68071-4118-42025-01-30Drug Facts
68071-4118-52025-01-30Drug Facts
68071-4118-62025-01-30Drug Facts
68071-4118-22020-08-19Drug Facts
68071-4118-32020-08-19Drug Facts
68071-4118-42020-08-19Drug Facts
68071-4118-52020-08-19Drug Facts
68071-4118-62020-08-19Drug Facts
68071-4118-22020-01-31Drug Facts
68071-4118-32020-01-31Drug Facts
68071-4118-42020-01-31Drug Facts
68071-4118-52020-01-31Drug Facts
68071-4118-62020-01-31Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68071-4118-2ACETAMINOPHENPain Reliever,Fever Reducer20 in 1 BOTTLETABLET204
68071-4118-3ACETAMINOPHENPain Reliever,Fever Reducer30 in 1 BOTTLETABLET304
68071-4118-4ACETAMINOPHENPain Reliever,Fever Reducer40 in 1 BOTTLETABLET404
68071-4118-5ACETAMINOPHENPain Reliever,Fever Reducer25 in 1 BOTTLETABLET254
68071-4118-6ACETAMINOPHENPain Reliever,Fever Reducer60 in 1 BOTTLETABLET604

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68071-4118ACETAMINOPHEN PAIN RELIEVER,FEVER REDUCER (ACETAMINOPHEN) TABLET [NUCARE PHARMACEUTICALS,INC.]4Legacy NDC, 5 package rows20220121_5b6f4839-1f2b-94b2-e053-2a91aa0a85e0.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313782acetaminophen 325 MG Oral TabletPSN5b6f4839-1f2b-94b2-e053-2a91aa0a85e04
313782acetaminophen 325 MG Oral TabletSCD5b6f4839-1f2b-94b2-e053-2a91aa0a85e04
313782APAP 325 MG Oral TabletSY5b6f4839-1f2b-94b2-e053-2a91aa0a85e04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68071-4118-36807141180330 TABLET in 1 BOTTLE (68071-4118-3) 30 tablet2017-10-130000-00-00NoNoCurrent