Home NDC 69168-011 Acetaminophen 500mg
Product NDC 69168-011
11-digit product format 691680011
Labeler code 69168
Product ID 69168-011_11b91c20-790a-4874-9060-27cd40f6a34d
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen 500mg
Dosage form TABLET
Route ORAL
Labeler Allegiant Health
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-04-15
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 500mg
Brand name suffix ES
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 69168-011-24 Acetaminophen 500mgES 1 in 1 CARTON TABLET 1 5 69168-011-24 Acetaminophen 500mgES 24 in 1 BOTTLE TABLET 24 5 69168-011-40 Acetaminophen 500mgES 40 in 1 BOTTLE TABLET 40 5 69168-011-40 Acetaminophen 500mgES 1 in 1 CARTON TABLET 1 5 69168-011-50 Acetaminophen 500mgES 50 in 1 BOTTLE TABLET 50 5 69168-011-50 Acetaminophen 500mgES 1 in 1 CARTON TABLET 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 69168-011 ACETAMINOPHEN 500MG ES (ACETAMINOPHEN 500MG) TABLET [ALLEGIANT HEALTH] 5 Current NDC, Legacy NDC, 6 package rows 20231115_91acc132-01b6-467b-9af5-70f4dc93e087.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 44 of 79 · 1,561 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 69168-011-24 69168001124 1 BOTTLE in 1 CARTON (69168-011-24) / 24 TABLET in 1 BOTTLE 1 bottle 2021-12-15 0000-00-00 No No Current 69168-011-40 69168001140 1 BOTTLE in 1 CARTON (69168-011-40) / 40 TABLET in 1 BOTTLE 1 bottle 2016-04-15 0000-00-00 No No Current 69168-011-50 69168001150 1 BOTTLE in 1 CARTON (69168-011-50) / 50 TABLET in 1 BOTTLE 1 bottle 2016-04-15 0000-00-00 No No Current