Home NDC 70000-0674 leader infants pain and fever
Product NDC 70000-0674
11-digit product format 700000674
Labeler code 70000
Product ID 70000-0674_9e89c59e-c284-40a4-b75b-d568c595ea06
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 2024-05-06
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 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 Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 70000-0674-1 leader infants pain and fever 59 mL in 1 BOTTLE SUSPENSION 59 2 70000-0674-1 leader infants pain and fever 1 in 1 CARTON SUSPENSION 1 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0674 LEADER INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER] 2 Current NDC, 2 package rows 20240507_cfbb8553-f3ac-437d-8f63-caa93f257a77.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 70000-0674-1 70000067401 1 BOTTLE in 1 CARTON (70000-0674-1) / 59 mL in 1 BOTTLE 1 bottle 2024-05-06 No No Current