Home NDC 68071-3565 Regular Strength Pain Relief
Product NDC 68071-3565
11-digit product format 680713565
Labeler code 68071
Product ID 68071-3565_102c9ec0-39ad-d05e-e063-6294a90af363
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 1989-01-01
Substance ACETAMINOPHEN
Active strength 325 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 Regular Strength Pain Relief
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 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 313782 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 68071-3565-0 Regular Strength Pain Relief 100 in 1 BOTTLE TABLET 100 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68071-3565 REGULAR STRENGTH PAIN RELIEF (ACETAMINOPHEN) TABLET [NUCARE PHARMACEUTICALS,INC.] 1 Current NDC, 1 package rows 20240131_102bdcde-cb90-f248-e063-6394a90aac79.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 68071-3565-0 68071356500 100 TABLET in 1 BOTTLE (68071-3565-0) 100 tablet 2024-01-30 No No Current