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

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 · 24 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	10564-0910-2	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	10564-0910-2	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	10564-0910-2	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	10564-0910-2	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	10564-0910-2	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	10564-0910-2	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	10564-0910-2	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	10564-0910-2	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	10564-0910-2	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	10564-0910-2	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	10564-0910-2	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	10564-0910-2	`9bebd1f3094a…`	`5416666fcb17…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
MENTHOL	2.5 mg/194.851

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
L7T10EIP3A	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1725069	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2669183c-7a58-037e-e054-00144ff88e88	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10564-0910-2	2024-12-13	C162847	48780-1	9d75b9d0-ed61-f424-e053-dadaa90a57ce	2669183c-7a58-037e-e054-00144ff88e88
10564-0910-2	2020-01-31	C162847	48780-1	9d75b9d0-ed61-f424-e053-dadaa90a57ce	2669183c-7a58-037e-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
10564-0910-2	Dentek Canker Cover	1 in 1 CARTON	PATCH, EXTENDED RELEASE	1		10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
10564-0910	DENTEK CANKER COVER (MENTHOL) PATCH, EXTENDED RELEASE [BERSHTEL ENTERPRISES]	9	Current NDC, Legacy NDC, 1 package rows	20241215_2669183c-7a58-037e-e054-00144ff88e88.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 4 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GingiCaine Gel, Mint Julep	GINGICAINE GEL, MINT JULEP FLABVOR	Gingi-Pak a Division of the Belport	6285fe10-08ba-8044-e053-2991aa0a8e8b	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Pina Colada	GINGICAINE GEL, PINA COLADA FLAVOR	Gingi-Pak a Division of the Belport	6284e1fe-be33-69bf-e053-2991aa0a90ab	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine Gel, Chocolate Mint	GINGICAINE GEL, CHOCOLATE MINT FLAVOR	Gingi-Pak a Division of the Belport	6285c4f2-c139-49a9-e053-2991aa0a2b03	2026-06-29	Warnings	Exact identifier application number: M022
UltraCare Anesthetic Gel	BENZOCAINE	The Bellport Company, Inc. dba Gingi-Pak	f5dd8fa8-0b6a-5a30-e053-2995a90ad194	2026-06-26	Warnings	Exact identifier application number: M022
GingiCaine Gel	GINGICAINE GEL BANANA FLAVOR	Gingi-Pak a Division of the Belport	62857d06-a829-4efa-e053-2991aa0a6d15	2026-06-25	Warnings	Exact identifier application number: M022
GingiCaine Gel, Cotton Candy Flavor	GINGICAINE GEL, COTTON CANDY FLAVOR	Gingi-Pak a Division of the Belport	628515a5-175f-ac2c-e053-2991aa0a19ce	2026-06-25	Warnings	Exact identifier application number: M022
Perox-A-Mint Solution	HYDROGEN PEROXIDE	Sage Products, LLC	50823ff5-ad08-4449-bc4a-9a8ae25ec0d5	2026-06-24	Warnings	Exact identifier application number: M022
Antiseptic Oral Rinse	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	efff8bae-154d-46bc-8dd4-716800425663	2026-06-24		Exact identifier application number: M022
Anbesol Maximum Strength	BENZOCAINE	Foundation Consumer Brands	8c6ac499-9bd2-4ea5-9f26-df7947bff4a6	2026-06-22	Warnings	Exact identifier application number: M022
Anbesol Maximum Strength	BENZOCAINE	Foundation Consumer Brands	dcc37403-0192-4658-bb7a-059273ce0047	2026-06-22	Warnings	Exact identifier application number: M022
Toothache	POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE	Guchutang Biotechnology (Longyan) Co., Ltd	54ad2ceb-272f-e5ba-e063-6394a90aec5f	2026-06-20	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	Delon Laboratories (1990) Ltd	d4aa09bf-8207-47dd-bc42-01e660da9438	2026-06-16	Warnings	Exact identifier application number: M022
TideFresh MOUTH SORE AND TOOTHACHE	BENZOCAINE 20% MOUTH SORE AND TOOTHACHE	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	541e1814-c00e-efdf-e063-6394a90a41a1	2026-06-13	Warnings	Exact identifier application number: M022
Chloraseptic Sore Throat Max	PHENOL AND GLYCERIN	Prestige Brands Holdings, Inc.	882c940c-b3c3-4aa4-8d64-e4260f066ff4	2026-06-08	Warnings	Exact identifier application number: M022
Orazen	SODIUM MONOFLUOROPHOSPHATE	Orazen Inc	fa5b6bd8-443f-79e7-e053-6394a90a5513	2026-06-03	Warnings	Exact identifier application number: M022
Fishermans Friend Mixed Berry	MENTHOL	Lofthouse of Fleetwood	53391c4d-ee2d-ade3-e063-6394a90ac77d	2026-06-01	Warnings	Exact identifier application number: M022
Orajel Medicated for Toothache and Gum, Liquid	BENZOCAINE AND MENTHOL	Church & Dwight Co., Inc.	ac3d605d-241d-1a6f-e053-2a95a90ae391	2026-06-01	Warnings	Exact identifier application number: M022
MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF	BENZOCAINE AND MENTHOL, UNSPECIFIED FORM	Reckitt Benckiser LLC	6140d487-d87c-4954-9247-83492bcc5738	2026-05-27	Warnings	Exact identifier application number: M022
Dolodent Maximum Strength	BENZOCAINE	Pharmadel LLC	351ecc2b-cc1a-2bbf-e063-6394a90a5c14	2026-05-26	Warnings	Exact identifier application number: M022
MOUTH ULCER	PANTHENOL	Guangzhou Shengli Shidai Cosmetics Co., Ltd.	5264f81c-bffe-4f6d-e063-6394a90ae3bf	2026-05-22	Warnings	Exact identifier application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1725069	menthol 2.5 MG Mucous Membrane Medicated Patch	PSN	2669183c-7a58-037e-e054-00144ff88e88	10
1725069	menthol 2.5 MG Medicated Patch	SCD	2669183c-7a58-037e-e054-00144ff88e88	10
1725069	menthol 2.5 MG Mucous Membrane Topical Patch	SY	2669183c-7a58-037e-e054-00144ff88e88	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
10564-0910-2	10564091002	1 PATCH, EXTENDED RELEASE in 1 CARTON (10564-0910-2)	2015-12-01	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Dentek Canker Cover - Bershtel Enterprises	Bershtel Enterprises	2025-12-31	HUMAN OTC DRUG LABEL	10