Home NDC 0536-1413 Acetaminophen
Product NDC 0536-1413
11-digit product format 005361413
Labeler code 0536
Product ID 0536-1413_c1c09905-1731-444f-9c1b-5cb995585f16
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Rugby Laboratories
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-10-03
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.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 0536-1413-47 Acetaminophen 2 in 1 POUCH TABLET, FILM COATED 2 2 0536-1413-48 Acetaminophen 50 in 1 CARTON TABLET, FILM COATED 50 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0536-1413 ACETAMINOPHEN TABLET, FILM COATED [RUGBY LABORATORIES] 1 Current NDC, 2 package rows 20241004_b16ed4ef-689c-4df2-ab6c-207aa8b9925d.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 79 · 1,579 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 0536-1413-47 00536141347 2 in 1 POUCH Historical 0536-1413-48 00536141348 50 POUCH in 1 CARTON (0536-1413-48) / 2 TABLET, FILM COATED in 1 POUCH (0536-1413-47) 50 pouch 2024-10-03 No No Current