Home NDC 53329-195 Medline
Product NDC 53329-195
11-digit product format 533290195
Labeler code 53329
Product ID 53329-195_536fe5f7-5321-3c6f-e063-6294a90abb04
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 2024-02-20
Marketing end 2029-11-30
Substance ACETAMINOPHEN
Active strength 500 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 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 53329-195-30 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 53329-195 MEDLINE (ACETAMINOPHEN) TABLET [MEDLINE INDUSTRIES, LP] 2 Current NDC, 1 package rows 20250202_fc5e6f2a-e813-0666-e053-6394a90a66a7.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 53329-195-30 53329019530 100 TABLET in 1 BOTTLE (53329-195-30) 100 tablet 2024-02-20 2029-11-30 No No Historical