Home NDC 68196-919 acetaminophen
Product NDC 68196-919
11-digit product format 681960919
Labeler code 68196
Product ID 68196-919_2d2a7fc6-966a-4716-a3af-98e09b1dc3a7
Type HUMAN OTC DRUG
Nonproprietary name acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Sam's West Inc
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 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 68196-919-05 acetaminophenextra strength 400 in 1 BOTTLE, PLASTIC TABLET, COATED 400 13
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68196-919 ACETAMINOPHEN EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [SAM'S WEST INC] 12 Current NDC, Legacy NDC, 1 package rows 20241027_dd99efd0-4ca4-4dc6-a940-bebd17ac8f8d.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 Marketing start Marketing end Sample Exclude flag Status 68196-919-05 68196091905 400 TABLET, COATED in 1 BOTTLE, PLASTIC (68196-919-05) 2004-05-10 0000-00-00 No No Current