FDA.reportPublic FDA data

Menthol Cough Drop

Product NDC
70000-0268
11-digit product format
700000268
Labeler code
70000
Product ID
70000-0268_d5516a88-c73e-5d32-e053-2a95a90a115b
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
Cardinal Health
Application
part341
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2017-03-07
Marketing end
0000-00-00
Substance
MENTHOL
Active strength
5 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 productproduct70000-0268DDiscontinued by firm2026-10-05
excluded packagepackage70000-026870000-0268-1DDiscontinued by firm2026-10-05

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
70000-0268-1EA - Each70000-02686103570b-9728-4a16-afc0-9451ff0923dd12017-11-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0268MENTHOL COUGH DROP (MENTHOL) LOZENGE [CARDINAL HEALTH]5Legacy NDC20241203_4a3d9f5c-520c-5a32-e054-00144ff8d46c.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0268-17000002680130 LOZENGE in 1 BAG (70000-0268-1) 30 lozenge2017-03-070000-00-00NoNoCurrent