Home NDC 68016-762-00 EXTRA STRENGTH PAIN RELIEVER
Product NDC 68016-762
Requested package NDC 68016-762-00
11-digit product format 680160762
Labeler code 68016
Product ID 68016-762_eeb46f68-aec9-6ca8-e053-2995a90aac1f
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN, ASPIRIN AND CAFFEINE
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PHARMACY VALUE ALLIANCE, LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2020-01-01
Marketing end 0000-00-00
Substance ACETAMINOPHEN; ASPIRIN; CAFFEINE
Active strength 250 mg/1; mg/1; mg/1
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Central Nervous System Stimulant [EPC], Central Nervous System Stimulation [PE], Cyclooxygenase Inhibitors [MoA], Decreased Platelet Aggregation [PE], Decreased Prostaglandin Production [PE], Methylxanthine [EPC], Nonsteroidal Anti-inflammatory Drug [EPC], Platelet Aggregation Inhibitor [EPC], Xanthines [CS]
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record 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 · 3 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 68016-762 68016-762-00 I Inactivated by FDA excluded / ndc_excluded.zip fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 68016-762 68016-762-00 I Inactivated by FDA excluded / ndc_excluded.zip 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 68016-762 68016-762-00 I Inactivated by FDA excluded / ndc_excluded.zip bd6a592717d7…303034d00443…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
FDA-Initiated Inactive NDC Indexing# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-762 EXTRA STRENGTH PAIN RELIEVER (ACETAMINOPHEN, ASPIRIN AND CAFFEINE) TABLET, FILM COATED [PHARMACY VALUE ALLIANCE, LLC] 4 Legacy NDC 20241130_b686549f-4daf-f4c0-e053-2a95a90afb56.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68016-762-00 68016076200 1 BOTTLE in 1 CARTON (68016-762-00) > 100 TABLET, FILM COATED in 1 BOTTLE 1 bottle 2020-01-01 0000-00-00 No No Current