FDA.reportPublic FDA data

Leader Cherry Sore Throat Lozenges

Product NDC
70000-0554
11-digit product format
700000554
Labeler code
70000
Product ID
70000-0554_d551e722-8de5-d0b1-e053-2995a90a6c90
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
LOZENGE
Route
ORAL
Labeler
Cardinal Health
Application
part356
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2020-06-04
Marketing end
0000-00-00
Substance
BENZOCAINE; MENTHOL
Active strength
15 mg/1; mg/1
NDC exclude flag
No
Listing certified through
2023-12-31
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 productproduct70000-0554DDiscontinued by firm2026-10-12
excluded packagepackage70000-055470000-0554-1DDiscontinued by firm2026-10-12

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
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0554LEADER CHERRY SORE THROAT LOZENGES (BENZOCAINE) LOZENGE [CARDINAL HEALTH]4Legacy NDC20241203_a7485605-4964-7caa-e053-2a95a90a0284.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0554-17000005540118 LOZENGE in 1 BLISTER PACK (70000-0554-1) 18 lozenge2020-06-040000-00-00NoNoCurrent