Home NDC 36800-450 Childrens Pain and Fever
Product NDC 36800-450
11-digit product format 368000450
Labeler code 36800
Product ID 36800-450_f3af2f48-9cc9-4fa0-8b8a-67574a1d84d4
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler Topco Associates, LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-15
Substance ACETAMINOPHEN
Active strength 160 mg/1
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 Childrens Pain and Fever
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 160 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 313820 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 36800-450-08 Childrens Pain and Fever 1 in 1 CARTON TABLET, CHEWABLE 1 10 36800-450-08 Childrens Pain and Fever 24 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 24 10
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-450 CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) TABLET, CHEWABLE [TOPCO ASSOCIATES, LLC] 9 Current NDC, Legacy NDC, 2 package rows 20250316_87af092c-99e6-475d-81af-b9fd8fc337d7.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 68 of 79 · 1,576 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 36800-450-08 36800045008 1 BOTTLE, PLASTIC in 1 CARTON (36800-450-08) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2019-02-15 0000-00-00 No No Current