KY Duration for Him

Product NDC
72854-683
Requested package NDC
72854-683-01
11-digit product format
728540683
Labeler code
72854
Product ID
72854-683_11fed0f0-a201-4afe-8e84-964620a55c7c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
GEL
Route
TOPICAL
Labeler
RB Health (US) LLC
Application
part348
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-09-01
Marketing end
0000-00-00
Substance
BENZOCAINE
Active strength
7 g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage72854-68372854-683-01DDiscontinued by firm2026-10-16

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
72854-683KY DURATION FOR HIM (BENZOCAINE) GEL [RB HEALTH (US) LLC]3Legacy NDC20241225_2d3de38b-4005-40ec-9305-ba688fc67817.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
72854-683-01728540683011 CAN in 1 CARTON (72854-683-01) > 5 mL in 1 CAN1 can2020-09-010000-00-00NoNoCurrent