Home NDC 70000-0481 leader childrens pain and fever
Product NDC 70000-0481
11-digit product format 700000481
Labeler code 70000
Product ID 70000-0481_b2eb4bb7-834b-483c-8ad0-6dc84aae00d9
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 2019-02-25
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 leader childrens 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 70000-0481-1 leader childrens pain and fever 118 mL in 1 BOTTLE SUSPENSION 118 3 70000-0481-1 leader childrens pain and fever 1 in 1 CARTON SUSPENSION 1 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0481 LEADER CHILDRENS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER] 3 Current NDC, Legacy NDC, 2 package rows 20240713_5bcc5da9-7e64-4308-a5be-2f47a8ca774d.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 59 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 70000-0481-1 70000048101 1 BOTTLE in 1 CARTON (70000-0481-1) / 118 mL in 1 BOTTLE 1 bottle 2019-02-25 0000-00-00 No No Current