Home NDC 70000-0472-1 leader infants pain and fever
Product NDC 70000-0472
Requested package NDC 70000-0472-1
11-digit product format 700000472
Labeler code 70000
Product ID 70000-0472_1f3eb8f8-a02a-48b7-9b8c-0811f0a29331
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form SUSPENSION
Route ORAL
Labeler Cardinal Health 110, LLC. dba Leader
Application part343
Marketing category OTC MONOGRAPH NOT FINAL
Marketing start 2019-03-12
Marketing end 0000-00-00
Substance ACETAMINOPHEN
Active strength 160 mg/5mL
NDC exclude flag No
Listing certified through 2022-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 1 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 70000-0472 70000-0472-1 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 70000-0472 LEADER INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER] 3 Legacy NDC 20240719_fb6566ed-8fd3-4242-81ac-383a6a5a4fbe.zip
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 70000-0472-1 70000047201 1 BOTTLE in 1 CARTON (70000-0472-1) > 59 mL in 1 BOTTLE 1 bottle 2019-03-12 0000-00-00 No No Current