Home NDC 68071-3907 Extra Strength Acetaminophen
Product NDC 68071-3907
11-digit product format 680713907
Labeler code 68071
Product ID 68071-3907_4266d35a-cdb8-50f2-e063-6294a90a1002
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals, Inc.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-11-01
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 Acetaminophen
Listing expiration 2026-12-31
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.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3907-2 Extra Strength Acetaminophen 20 in 1 BOTTLE TABLET 20 2 68071-3907-3 Extra Strength Acetaminophen 30 in 1 BOTTLE TABLET 30 2 68071-3907-5 Extra Strength Acetaminophen 45 in 1 BOTTLE TABLET 45 2
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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 68071-3907-2 68071390702 20 TABLET in 1 BOTTLE (68071-3907-2) 20 tablet 2025-10-30 No No Current 68071-3907-3 68071390703 30 TABLET in 1 BOTTLE (68071-3907-3) 30 tablet 2025-10-30 No No Current 68071-3907-5 68071390705 45 TABLET in 1 BOTTLE (68071-3907-5) 45 tablet 2025-10-21 No No Current