Home NDC 61504-104 Acetaminophen
Product NDC 61504-104
11-digit product format 615040104
Labeler code 61504
Product ID 61504-104_09083a11-e010-d76d-e063-6294a90a7981
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler AMERIFOODS TRADING COMPANY
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-30
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 61504-104-04 Acetaminophen 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3 61504-104-04 Acetaminophen 1 in 1 CARTON TABLET, COATED 1 3 61504-104-06 Acetaminophen 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 61504-104 ACETAMINOPHEN TABLET, COATED [AMERIFOODS TRADING COMPANY] 3 Current NDC, 3 package rows 20231101_f6dd387d-c768-9443-e053-6394a90aca14.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 60 of 79 · 1,579 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 61504-104-04 61504010404 1 BOTTLE, PLASTIC in 1 CARTON (61504-104-04) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2023-10-30 No No Current 61504-104-06 61504010406 500 TABLET, COATED in 1 BOTTLE, PLASTIC (61504-104-06) 2023-10-30 No No Current