Home NDC 0615-8610-39 Acetaminophen
Product NDC 0615-8610
Requested package NDC 0615-8610-39
11-digit product format 006158610
Labeler code 0615
Product ID 0615-8610_4e18d785-6ccf-4f42-b6bc-e8ff4364e149
Type HUMAN OTC DRUG
Nonproprietary name ACETAMINOPHEN
Dosage form TABLET, FILM COATED
Route ORAL
Labeler NCS HealthCare of KY, LLC dba Vangard Labs
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-07-09
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes 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 0615-8610-05 Acetaminophen 15 in 1 BLISTER PACK TABLET, FILM COATED 15 1 0615-8610-30 Acetaminophen 5 in 1 BLISTER PACK TABLET, FILM COATED 5 1 0615-8610-30 Acetaminophen 6 in 1 BOX, UNIT-DOSE TABLET, FILM COATED 6 1 0615-8610-39 Acetaminophen 30 in 1 BLISTER PACK TABLET, FILM COATED 30 1
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 84 · 1,678 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Sample Exclude flag Status 0615-8610-39 00615861039 30 TABLET, FILM COATED in 1 BLISTER PACK (0615-8610-39) 2026-01-30 No No Current