Home NDC 76162-079 Childrens Pain and Fever
Product NDC 76162-079
11-digit product format 761620079
Labeler code 76162
Product ID 76162-079_05447f58-f56f-4a85-83d9-350d085e3de9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler TOPCO ASSOCIATES LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2022-12-29
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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 Childrens Pain and Fever
Listing expiration 2026-12-31 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 76162-079-36 Childrens Pain and Fever 1 in 1 CARTON SUSPENSION 1 3 76162-079-36 Childrens Pain and Fever 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 76162-079 CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC] 2 Current NDC, 2 package rows 20241012_bbc367cc-6c79-498e-8fca-1347e6ea1a8c.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 64 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 76162-079-36 76162007936 1 BOTTLE, PLASTIC in 1 CARTON (76162-079-36) / 118 mL in 1 BOTTLE, PLASTIC 2022-12-29 No No Current