FDA.reportPublic FDA data

Acetaminophen,Caffeine and Pyrilamine Maleate

Product NDC
24689-121
Requested package NDC
24689-121-01
11-digit product format
246890121
Labeler code
24689
Product ID
24689-121_f17e72c0-45e7-1e82-e053-2a95a90a115f
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen,Caffeine and Pyrilamine Maleate
Dosage form
TABLET
Route
ORAL
Labeler
APNAR PHARMA LP
Application
part343
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2022-07-05
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; CAFFEINE; PYRILAMINE MALEATE
Active strength
500 mg/1; mg/1; mg/1
Pharmacologic classes
Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Methylxanthine [EPC], Xanthines [CS]
NDC exclude flag
No
Listing certified through
2024-12-31
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 packagepackage24689-12124689-121-01DDiscontinued by firm2026-10-05

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 · 9 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 2025-12-05DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10DDiscontinued by firmcdf11ea48f46…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…

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
24689-121-012025-02-01Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets
24689-121-022025-02-01Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets
24689-121-012025-01-30Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets
24689-121-022025-01-30Acetaminophen 500mg, Caffeine 60mg, Pyrilamine Maleate 15mg Tablets

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
24689-121-012468901210120 TABLET in 1 BOTTLE (24689-121-01) 20 tablet2022-07-050000-00-00NoNoCurrent