Home NDC 51316-098 Childrens Pain and Fever
Product NDC 51316-098
11-digit product format 513160098
Labeler code 51316
Product ID 51316-098_dc7442bd-8264-4b7a-a069-5c2d28e68e90
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-05
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
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/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 51316-098-19 Childrens Pain and Fever 1 in 1 CARTON SUSPENSION 1 6 51316-098-19 Childrens Pain and Fever 237 mL in 1 BOTTLE, PLASTIC SUSPENSION 237 6 51316-098-36 Childrens Pain and Fever 1 in 1 CARTON SUSPENSION 1 6 51316-098-36 Childrens Pain and Fever 118 mL in 1 BOTTLE, PLASTIC SUSPENSION 118 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-098 CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED] 4 Current NDC, 4 package rows 20240829_d96a1531-772b-4a5c-89e4-66fff1fa3d78.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 63 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 Sample Exclude flag Status 51316-098-19 51316009819 1 BOTTLE, PLASTIC in 1 CARTON (51316-098-19) / 237 mL in 1 BOTTLE, PLASTIC 2024-04-05 No No Current 51316-098-36 51316009836 1 BOTTLE, PLASTIC in 1 CARTON (51316-098-36) / 118 mL in 1 BOTTLE, PLASTIC 2024-04-05 No No Current