FDA.reportPublic FDA data

Extra Strenghth Acetaminophen

Product NDC
69729-107
Requested package NDC
69729-107-40
11-digit product format
697290107
Labeler code
69729
Product ID
69729-107_ae6d90a9-4c7b-4798-e053-2a95a90aae0c
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen
Dosage form
TABLET
Route
ORAL
Labeler
OPMX
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2017-07-31
Marketing end
0000-00-00
Substance
ACETAMINOPHEN
Active strength
500 mg/1
NDC exclude flag
No
Listing certified through
2021-12-31
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 packagepackage69729-10769729-107-40IInactivated 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 · 10 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…
2025-03-22 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…
2022-08-30 03:57 UTC · source 2022-08-29IInactivated by FDAfb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08IInactivated by FDA86f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01IInactivated by FDAbd6a592717d7…303034d00443…

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2025-07-29Temp X Caplets
2025-03-19Temp X Caplets
2025-01-30Temp X Caplets
2023-12-15Temp X Caplets
2022-01-28Temp X Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-107-40Extra Strenghth Acetaminophen1 in 1 CARTONTABLET15
69729-107-40Extra Strenghth Acetaminophen40 in 1 BOTTLETABLET405

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-107EXTRA STRENGHTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET [OPMX LLC]5Legacy NDC, 2 package rows20250322_ae6dae28-6f4f-16d1-e053-2995a90adbab.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
198440acetaminophen 500 MG Oral TabletPSNae6dae28-6f4f-16d1-e053-2995a90adbab5
198440acetaminophen 500 MG Oral TabletSCDae6dae28-6f4f-16d1-e053-2995a90adbab5
198440APAP 500 MG Oral TabletSYae6dae28-6f4f-16d1-e053-2995a90adbab5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69729-107-40697290107401 BOTTLE in 1 CARTON (69729-107-40) > 40 TABLET in 1 BOTTLE1 bottle2017-07-310000-00-00NoNoCurrent