Home NDC 53145-830 Duralgina Extra Strength
Product NDC 53145-830
11-digit product format 531450830
Labeler code 53145
Product ID 53145-830_544e3d7e-a75a-384f-e063-6294a90a5baa
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler Menper Distributors, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-06-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 Duralgina Extra Strength
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
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 1 of 83 · 1,657 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53145-830-30 53145083030 1 BOTTLE in 1 CARTON (53145-830-30) / 30 TABLET in 1 BOTTLE 1 bottle 2026-06-01 No No Current