Home NDC 68071-5239 Acetaminophen
Product NDC 68071-5239
11-digit product format 680715239
Labeler code 68071
Product ID 68071-5239_2a95afd1-cd26-371c-e063-6294a90a97d4
Type HUMAN OTC DRUG
Nonproprietary name Extra Strength Pain Relief
Dosage form TABLET
Route ORAL
Labeler NuCare Pharmaceuticals,Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-01-01
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 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.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-5239-3 Acetaminophen 30 in 1 BOTTLE TABLET 30 7 68071-5239-5 Acetaminophen 45 in 1 BOTTLE TABLET 45 7 68071-5239-9 Acetaminophen 90 in 1 BOTTLE TABLET 90 7
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-5239 ACETAMINOPHEN (EXTRA STRENGTH PAIN RELIEF) TABLET [NUCARE PHARMACEUTICALS,INC.] 7 Current NDC, Legacy NDC, 3 package rows 20250101_a32f346e-71d0-cc11-e053-2a95a90ae88c.zip
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 14 of 42 · 833 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 68071-5239-3 68071523903 30 TABLET in 1 BOTTLE (68071-5239-3) 30 tablet 2020-04-13 No No Current 68071-5239-5 68071523905 45 TABLET in 1 BOTTLE (68071-5239-5) 45 tablet 2020-04-13 0000-00-00 No No Current 68071-5239-9 68071523909 90 TABLET in 1 BOTTLE (68071-5239-9) 90 tablet 2020-04-13 0000-00-00 No No Current