Home NDC 51013-320 Extra Strength Acetaminophen
Product NDC 51013-320
11-digit product format 510130320
Labeler code 51013
Product ID 51013-320_1b2f1b11-905c-4c77-b609-ffae53749092
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler PuraCap Pharmaceutical LLC
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2017-11-09
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Additional Listing Data#
Finished product Yes
Brand name base Extra Strength 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 51013-320-54 Extra Strength Acetaminophen 2 in 1 POUCH TABLET, FILM COATED 2 1 51013-320-54 Extra Strength Acetaminophen 15 in 1 CARTON TABLET, FILM COATED 15 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51013-320 EXTRA STRENGTH ACETAMINOPHEN (ACETAMINOPHEN) TABLET, FILM COATED [PURACAP PHARMACEUTICAL LLC] 1 Current NDC, Legacy NDC, 2 package rows 20171110_f3c57374-1408-4459-a4de-ad12c2fc6b61.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 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 51013-320-54 51013032054 15 POUCH in 1 CARTON (51013-320-54) / 2 TABLET, FILM COATED in 1 POUCH 15 pouch 2017-11-09 0000-00-00 No No Current