Home NDC 53329-194 Medline
Product NDC 53329-194
11-digit product format 533290194
Labeler code 53329
Product ID 53329-194_536fe712-15ad-fab3-e063-6394a90a44ca
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen
Dosage form TABLET
Route ORAL
Labeler Medline Industries, LP
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-01
Marketing end 2027-03-31
Substance ACETAMINOPHEN
Active strength 325 mg/1
NDC exclude flag No
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 Medline Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 325 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 313782 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 53329-194-30 Medline 100 in 1 BOTTLE TABLET 100 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-194 MEDLINE (ACETAMINOPHEN) TABLET [MEDLINE INDUSTRIES, LP] 2 Current NDC, 1 package rows 20240711_fc5d92c2-4bbe-8ad1-e053-6294a90a65b6.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 63 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 Marketing end Sample Exclude flag Status 53329-194-30 53329019430 100 TABLET in 1 BOTTLE (53329-194-30) 100 tablet 2024-07-01 2027-03-31 No No Historical