Home NDC 55301-519 Acetaminophen
Product NDC 55301-519
11-digit product format 553010519
Labeler code 55301
Product ID 55301-519_22c2ed82-d9d4-4ab9-8faa-01267b908876
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler ARMY AND AIR FORCE EXCHANGE SERVICE
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-05-10
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
Brand name suffix Extra Strength
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 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 55301-519-51 AcetaminophenExtra Strength 1 in 1 CARTON TABLET, COATED 1 19 55301-519-51 AcetaminophenExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 19 55301-519-60 AcetaminophenExtra Strength 1 in 1 CARTON TABLET, COATED 1 19 55301-519-60 AcetaminophenExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 19
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 55301-519 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [ARMY AND AIR FORCE EXCHANGE SERVICE] 17 Current NDC, Legacy NDC, 4 package rows 20240608_f3feca65-adc1-469f-bef6-12c860599abe.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.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 55301-519-51 55301051951 1 BOTTLE, PLASTIC in 1 CARTON (55301-519-51) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 0000-00-00 No No Current 55301-519-60 55301051960 1 BOTTLE, PLASTIC in 1 CARTON (55301-519-60) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2004-05-10 0000-00-00 No No Current