Dentek Canker Cover

Product NDC
10564-0910
11-digit product format
105640910
Labeler code
10564
Product ID
10564-0910_47419d1d-2da5-fed5-e063-6294a90a3d13
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
PATCH, EXTENDED RELEASE
Route
TRANSMUCOSAL
Labeler
Bershtel Enterprises
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-12-01
Substance
MENTHOL
Active strength
2.5 mg/194.851
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Dentek Canker Cover
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL2.5 mg/194.851

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1725069

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10564-0910-22024-12-13C16284748780-19d75b9d0-ed61-f424-e053-dadaa90a57ce2669183c-7a58-037e-e054-00144ff88e88
10564-0910-22020-01-31C16284748780-19d75b9d0-ed61-f424-e053-dadaa90a57ce2669183c-7a58-037e-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10564-0910-2Dentek Canker Cover1 in 1 CARTONPATCH, EXTENDED RELEASE110

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10564-0910DENTEK CANKER COVER (MENTHOL) PATCH, EXTENDED RELEASE [BERSHTEL ENTERPRISES]9Current NDC, Legacy NDC, 1 package rows20241215_2669183c-7a58-037e-e054-00144ff88e88.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1725069menthol 2.5 MG Mucous Membrane Medicated PatchPSN2669183c-7a58-037e-e054-00144ff88e8810
1725069menthol 2.5 MG Medicated PatchSCD2669183c-7a58-037e-e054-00144ff88e8810
1725069menthol 2.5 MG Mucous Membrane Topical PatchSY2669183c-7a58-037e-e054-00144ff88e8810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
10564-0910-2105640910021 PATCH, EXTENDED RELEASE in 1 CARTON (10564-0910-2) 2015-12-01NoNoHistorical