Home NDC 51316-643-04 Dye Free Infants Pain and Fever
Product NDC 51316-643
Requested package NDC 51316-643-04
11-digit product format 513160643
Labeler code 51316
Product ID 51316-643_2e04cbea-f8fc-77f6-e063-6394a90a45af
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler CVS
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-02-15
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 Dye Free 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 Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51316-643-04 Dye Free Infants Pain and Fever 1 in 1 BOX SUSPENSION 1 2 51316-643-04 Dye Free Infants Pain and Fever 60 mL in 1 BOTTLE SUSPENSION 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-643 DYE FREE INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS] 2 Current NDC, 2 package rows 20250216_1fde0f7c-4b5b-ae9c-e063-6394a90afa41.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 Units Marketing start Sample Exclude flag Status 51316-643-04 51316064304 1 BOTTLE in 1 BOX (51316-643-04) / 60 mL in 1 BOTTLE 1 bottle 2025-02-15 No No Current