Home NDC 36800-766-16 topcare infants pain and fever
Product NDC 36800-766
Requested package NDC 36800-766-16
11-digit product format 368000766
Labeler code 36800
Product ID 36800-766_21472a62-d6a7-438b-a5e4-c2845d8ffe13
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 2011-11-03
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 topcare infants 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 36800-766-16 topcare infants pain and fever 59 mL in 1 BOTTLE SUSPENSION 59 7 36800-766-16 topcare infants pain and fever 1 in 1 CARTON SUSPENSION 1 7
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-766 TOPCARE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [TOPCO ASSOCIATES LLC] 7 Current NDC, Legacy NDC, 2 package rows 20240726_a1145ac3-3e55-4bd5-a53e-6cf869add9a1.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 79 · 1,579 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 36800-766-16 36800076616 1 BOTTLE in 1 CARTON (36800-766-16) / 59 mL in 1 BOTTLE 1 bottle 2011-11-03 0000-00-00 No No Current