Home NDC 83324-078 Pain Relief
Product NDC 83324-078
11-digit product format 833240078
Labeler code 83324
Product ID 83324-078_458b4f7d-8f0c-2559-e063-6294a90a663b
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler CHAIN DRUG MARKETING ASSOCIATION, INC.
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-03
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
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 Pain Relief
Brand name suffix Extra Strength
Listing expiration 2026-12-31 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 83324-078-01 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-01 Pain ReliefExtra Strength 100 in 1 BOTTLE, PLASTIC TABLET, COATED 100 3 83324-078-05 Pain ReliefExtra Strength 500 in 1 BOTTLE, PLASTIC TABLET, COATED 500 3 83324-078-15 Pain ReliefExtra Strength 150 in 1 BOTTLE, PLASTIC TABLET, COATED 150 3 83324-078-24 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-24 Pain ReliefExtra Strength 24 in 1 BOTTLE, PLASTIC TABLET, COATED 24 3 83324-078-50 Pain ReliefExtra Strength 1 in 1 CARTON TABLET, COATED 1 3 83324-078-50 Pain ReliefExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-078 PAIN RELIEF EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [CHAIN DRUG MARKETING ASSOCIATION, INC.] 2 Current NDC, 8 package rows 20240615_c57c10fc-f182-4153-8974-ef359a5f5ac1.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 39 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 Sample Exclude flag Status 83324-078-01 83324007801 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-01) / 100 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current 83324-078-05 83324007805 500 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-05) 2024-04-03 No No Current 83324-078-15 83324007815 150 TABLET, COATED in 1 BOTTLE, PLASTIC (83324-078-15) 2024-04-03 No No Current 83324-078-24 83324007824 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-24) / 24 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current 83324-078-50 83324007850 1 BOTTLE, PLASTIC in 1 CARTON (83324-078-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 2024-04-03 No No Current