FDA.reportPublic FDA data

leader infants pain and fever

Product NDC
70000-0472
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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct70000-0472DDiscontinued by firm2026-10-05
excluded packagepackage70000-047270000-0472-1DDiscontinued by firm2026-10-05

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 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproduct70000-0472DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage70000-047270000-0472-1DDiscontinued by firmexcluded / ndc_excluded.zipd630ba8d3edf…732f749b63fb…

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0472-1ML - Milliliter70000-04723bdd4a14-1781-4926-b037-a2a0fed1284412019-08-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0472LEADER INFANTS PAIN AND FEVER (ACETAMINOPHEN) SUSPENSION [CARDINAL HEALTH 110, LLC. DBA LEADER]3Legacy NDC20240719_fb6566ed-8fd3-4242-81ac-383a6a5a4fbe.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0472-1700000472011 BOTTLE in 1 CARTON (70000-0472-1) > 59 mL in 1 BOTTLE1 bottle2019-03-120000-00-00NoNoCurrent