Home NDC 68071-3437 acetaminophen
Product NDC 68071-3437
11-digit product format 680713437
Labeler code 68071
Product ID 68071-3437_575e7de2-8194-8e73-e063-6394a90a1d8b
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 2018-07-26
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 acetaminophen
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 68071-3437-1 acetaminophen 120 in 1 BOTTLE TABLET 120 4 68071-3437-2 acetaminophen 20 in 1 BOTTLE TABLET 20 4 68071-3437-5 acetaminophen 45 in 1 BOTTLE TABLET 45 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3437 ACETAMINOPHEN TABLET [NUCARE PHARMACEUTICALS,INC.] 2 Current NDC, 3 package rows 20240815_fdb7331a-d029-8b2a-e053-6294a90adfcd.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 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 68071-3437-1 68071343701 120 TABLET in 1 BOTTLE (68071-3437-1) 120 tablet 2026-01-13 No No Current 68071-3437-2 68071343702 20 TABLET in 1 BOTTLE (68071-3437-2) 20 tablet 2023-06-09 No No Current 68071-3437-3 68071343703 30 TABLET in 1 BOTTLE (68071-3437-3) 30 tablet 2026-07-24 No No Current 68071-3437-5 68071343705 45 TABLET in 1 BOTTLE (68071-3437-5) 45 tablet 2023-06-09 No No Current