Home NDC 83324-161-04 Pain Reliever
Product NDC 83324-161
Requested package NDC 83324-161-04
11-digit product format 833240161
Labeler code 83324
Product ID 83324-161_c53b96b2-036b-4f5b-a739-29bef90e52db
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler QUALITY CHOICE (Chain Drug Marketing Association)
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-07-31
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 Pain Reliever
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 mg/5mL
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 307668 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83324-161-04 Pain Reliever 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 2 83324-161-04 Pain Reliever 1 in 1 BOX SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83324-161 PAIN RELIEVER (ACETAMINOPHEN) SUSPENSION [QUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)] 2 Current NDC, 2 package rows 20240731_2f9da3d6-229d-44d1-bd94-4bcddbbdb120.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 1 of 83 · 1,657 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 83324-161-04 83324016104 1 BOTTLE, PLASTIC in 1 BOX (83324-161-04) / 118 mL in 1 BOTTLE, PLASTIC 2024-07-31 No No Current