Home NDC 68016-543 Pain Reliever
Product NDC 68016-543
11-digit product format 680160543
Labeler code 68016
Product ID 68016-543_913edec4-45ba-48bd-8da0-23f38da8fd6a
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, FILM COATED
Route ORAL
Labeler Chain Drug Consortium
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-04-29
Marketing end 2026-11-30
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 Pain Reliever 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 68016-543-01 Pain Reliever 100 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 100 5 68016-543-01 Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 5 68016-543-24 Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 5 68016-543-24 Pain Reliever 24 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 24 5 68016-543-99 Pain Reliever 1 in 1 CARTON TABLET, FILM COATED 1 5 68016-543-99 Pain Reliever 225 in 1 BOTTLE, PLASTIC TABLET, FILM COATED 225 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 68016-543 PAIN RELIEVER (ACETAMINOPHEN) TABLET, FILM COATED [CHAIN DRUG CONSORTIUM] 4 Current NDC, Legacy NDC, 6 package rows 20240420_60d4b392-6ed0-4115-8154-24eaf72504a5.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 68016-543-01 68016054301 1 BOTTLE, PLASTIC in 1 CARTON (68016-543-01) / 100 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2022-04-29 2026-11-30 No No Current 68016-543-24 68016054324 1 BOTTLE, PLASTIC in 1 CARTON (68016-543-24) / 24 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2022-04-29 2026-11-30 No No Current 68016-543-99 68016054399 1 BOTTLE, PLASTIC in 1 CARTON (68016-543-99) / 225 TABLET, FILM COATED in 1 BOTTLE, PLASTIC 2022-04-29 2026-11-30 No No Historical