Home NDC 83059-0168 Extra Strength Pain Reliever mini softgels
Product NDC 83059-0168
11-digit product format 830590168
Labeler code 83059
Product ID 83059-0168_583e4167-fdd9-c249-e063-6294a90aba21
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500 mg
Dosage form CAPSULE, LIQUID FILLED
Route ORAL
Labeler Shield Pharmaceuticals Corp
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-08-04
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 Extra Strength Pain Reliever mini softgels
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 198439 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 63 of 79 · 1,579 matching rows.