Home NDC 51316-450 Pain and Fever Chewables
Product NDC 51316-450
11-digit product format 513160450
Labeler code 51316
Product ID 51316-450_394b9516-353d-479b-b263-c039c3b28886
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, CHEWABLE
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-05-22
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 Pain and Fever Chewables
Brand name suffix Childrens
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 51316-450-08 Pain and Fever ChewablesChildrens 1 in 1 CARTON TABLET, CHEWABLE 1 2 51316-450-08 Pain and Fever ChewablesChildrens 24 in 1 BOTTLE, PLASTIC TABLET, CHEWABLE 24 2
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 Marketing start Sample Exclude flag Status 51316-450-08 51316045008 1 BOTTLE, PLASTIC in 1 CARTON (51316-450-08) / 24 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC 2026-05-22 No No Current