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 9 of 40 · 782 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Wintergreen Peppermint	POTASSIUM NITRATE, SODIUM FLUORIDE	Twice Twice LLC	7b7beec2-e070-4102-a2a4-68c332fc9fb3	2026-01-19	Warnings	Exact identifier application number: M022
GuruNanda Sensitive	POTASSIUM NITRATE	GURUNANDA, LLC	3ef0d3d4-fd42-0181-e063-6394a90af09c	2026-01-19	Warnings	Exact identifier application number: M022
Up and Up Antiseptic	CETYLPYRIDINIUM CHLORIDE	Target Corporation	386ee9f9-598e-ad00-e063-6394a90aeb46	2026-01-19	Warnings	Exact identifier application number: M022
Colgate Sensitive Complete Protection	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	4a8f1d2f-b326-46d2-8914-d65ccc409edf	2026-01-18	Warnings	Exact identifier application number: M022
Colgate Sensitive Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	3b656928-af58-4ee9-8fb8-360688eb9bf3	2026-01-13	Warnings	Exact identifier application number: M022
Colgate Sensitive Enamel Health	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	a50d4259-8a79-417e-b381-72c7a8ec0418	2026-01-13	Warnings	Exact identifier application number: M022
Walgreens Sensitive Enamel Repair	SODIUM FLUORIDE	Walgreens	41d6384d-695b-b60b-e063-6394a90aa0b9	2026-01-09	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	HY-VEE, INC	47f738cc-7968-cc07-e063-6294a90af7ab	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Clinical White Stain Protector	SODIUM FLUORIDE	CVS Pharmacy	41d5c3a9-abe5-5528-e063-6294a90ada79	2026-01-09	Warnings	Exact identifier application number: M022
CVS Health Sensitive Enamel Repair	SODIUM FLUORIDE	CVS	41d547b3-2feb-8e83-e063-6294a90ae3cd	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive Prevent and Repair	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	e67410dc-a671-4611-8af1-097be071cd1c	2026-01-09	Warnings	Exact identifier application number: M022
Colgate Sensitive plus Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Colgate-Palmolive Company	2092c747-e025-47a9-9e54-731631d3c831	2026-01-09	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2e7fbf9d-553c-c7bf-e063-6294a90a5f79	2026-01-08	Warnings	Exact identifier application number: M022
HyVee Throat Drops Lemon Mint	MENTHOL	Xiamen Kang Zhongyuan Biotechnology Co., Ltd.	47e2650f-4f50-8d85-e063-6394a90a1ddc	2026-01-08	Warnings	Exact identifier application number: M022
Dentemp Canker Cover	CANKER COVER	DOC Brands	2b4b22e9-a03b-fb8f-e063-6394a90a8747	2026-01-08	Warnings	Exact identifier application number: M022
Crest 3D White Advanced	SODIUM MONOFLUOROPHOSPHATE	The Procter & Gamble Manufacturing Company	f3aa9a59-b4d4-05d9-e053-2995a90a0aea	2026-01-08		Exact identifier application number: M022
Oral B Plaque Defense Special Care Oral Rinse	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d503fad5-a378-0e60-e053-2a95a90abe65	2026-01-08	Warnings	Exact identifier application number: M022
Scope All Day CPC Antigingivitis/Antiplaque Mouthwash All Day	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d5f69341-b659-c74a-e053-2a95a90a317e	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Breath Purify and Gum Care	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	d71ed31f-cc33-2fc3-e053-2995a90ad39b	2026-01-08	Warnings	Exact identifier application number: M022
Crest Pro-Health Clinical	CETYLPYRIDINIUM CHLORIDE	The Procter & Gamble Manufacturing Company	0a295ee0-55c2-4f21-8f0a-70efc0e51694	2026-01-08	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