KAYLAAN

Product NDC: 82091-112
11-digit product format: 820910112
Labeler code: 82091
Product ID: 82091-112_2bd4481a-9890-537e-e063-6294a90a010d
Type: HUMAN OTC DRUG
Nonproprietary name: Zero Waste Refill For Toothpaste
Dosage form: TABLET, CHEWABLE
Route: DENTAL
Labeler: Kaylaan LLC
Application: M022
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2021-08-16
Substance: SODIUM FLUORIDE
Active strength: .37 mg/440mg
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	82091-112		I	Inactivated by FDA		2026-08-17
excluded package	package	82091-112	82091-112-10	I	Inactivated by FDA		2026-08-17

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 · 32 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	82091-112-10	I	Inactivated by FDA	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	82091-112-10	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	82091-112-10	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	82091-112-10	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	82091-112-10	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	82091-112-10	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	82091-112-10	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	82091-112-10	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82091-112-11	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	82091-112-10	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	82091-112-10	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	82091-112-10	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	82091-112-10	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	82091-112-10	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	82091-112-10	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	82091-112-10	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Additional Listing Data#

Finished product: Yes
Brand name base: KAYLAAN
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM FLUORIDE	.37 mg/440mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
8ZYQ1474W7	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
c68fd8c7-7ec3-cc3f-e053-2995a90a4395	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
82091-112-10	2023-01-30	C162847	48780-1	f386c64a-405f-0266-e053-dadaa90a7c1a	Kaylaan Mint Toothpaste Tablet

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
82091-112-11	KAYLAAN	74.3 mg in 1 BOX, UNIT-DOSE	TABLET, CHEWABLE	74.3		4
82091-112-10	KAYLAAN	74.3 mg in 1 BOX, UNIT-DOSE	TABLET, CHEWABLE	74.3		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82091-112	KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC]	4	Current NDC, Legacy NDC, 1 package rows	20250119_c68fd8c7-7ec3-cc3f-e053-2995a90a4395.zip
82091-112	KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC]	2	Current NDC, Legacy NDC, 1 package rows	20210913_cb6f6566-5fae-4827-e053-2995a90a43a7.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 1 of 42 · 822 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Saline	SALINE NASAL SPRAY	Dynarex Corporation	3247ae7d-554f-baab-e063-6294a90aa3ec	2026-08-25	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	WALMART INC. (see also Equate)	584b38ce-d1ef-4ecc-a887-7c96e7f9669f	2026-08-20	Warnings	Exact identifier application number: M022
Antiseptic	EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL	Walgreens	fb93c7f6-e025-4cf2-9997-acfe9a0debdd	2026-08-19	Warnings	Exact identifier application number: M022
CVS Saline	NASAL	CVS PHARMACY	f02c41b0-c78e-41cd-aa4a-2756bbe92087	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Honey Licorice Throat Drops	MENTHOL	Prestige Brands Holdings, Inc.	5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac	2026-08-19	Warnings	Exact identifier application number: M022
Ludens Dual Relief	PECTIN AND MENTHOL	Prestige Brands Holdings, Inc.	d0213cb3-ec8e-40cc-82c9-694032f0490f	2026-08-19	Warnings	Exact identifier application number: M022
CVS Health Sore Throat Fast Relief Oral Anesthetic	PHENOL	CVS Pharmacy,Inc.	4fb880db-2185-41ef-a5f9-8983a28d2c5b	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Cherry	PHENOL	CVS Pharmacy,Inc.	887c68e0-ff44-4bad-b360-56fb99ed9c45	2026-08-17	Warnings	Exact identifier application number: M022
CVS Sore Throat Menthol Flavor	PHENOL	CVS PHARMACY,INC.	665be058-b965-4b78-80b0-dd8524180932	2026-08-17	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent	HYDROGEN PEROXIDE	Harris Teeter, LLC	7e5f175d-f0d6-4665-ac14-1873d6b99c80	2026-08-12	Warnings	Exact identifier application number: M022
Gingicaine Gel Variety Pak	GINGICAINE GEL VARIETY PAK	Gingi-Pak a Division of the Belport	62ed4ff3-18f6-5c67-e053-2991aa0a7792	2026-08-11	Warnings	Exact identifier application number: M022
Hydrogen Peroxide 3 Percent ReadyInCase	HYDROGEN PEROXIDE	P & L Development, LLC	b0866db5-3b0d-4478-9b3b-1f077d2f5393	2026-08-06	Warnings	Exact identifier application number: M022
Ollie Fresh Mint	SODIUM FLUORIDE, POTASSIUM NITRATE	Brio Product Group LLC.	ebeec44f-3c22-43f2-9256-6ece6025c105	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	5868c5a1-273f-f023-e063-6394a90ac9d8	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58690bb5-9604-26a4-e063-6394a90afdbe	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586918cf-7b13-5999-e063-6294a90a88a9	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586924a0-322d-5dc3-e063-6294a90a1556	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	58692e90-de74-52d3-e063-6394a90a9702	2026-08-06	Warnings	Exact identifier application number: M022
Candee Caine Topical Anesthetic	BENZOCAINE	Top Quality Manufacturing, Inc.	586937ae-46af-7066-e063-6294a90ae53e	2026-08-06	Warnings	Exact identifier application number: M022
Freshness Blueberry Toothpaste100g	FRESHNESS BLUEBERRY TOOTHPASTE 100G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	586d1dba-87fc-b676-e063-6294a90a1470	2026-08-06	Warnings	Exact identifier application number: M022

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
8ZYQ1474W7	SODIUM FLUORIDE	7681-49-4	SODIUM FLUORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82091-112-10	82091011210	74.3 mg in 1 BOX, UNIT-DOSE (82091-112-10)	74.3 mg	2021-09-13	0000-00-00	No	No	Current
82091-112-11	82091011211	74.3 mg in 1 BOX, UNIT-DOSE (82091-112-11)	74.3 mg	2021-08-16	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Kaylaan Mint Toothpaste Tablet Refill	Kaylaan LLC	2025-01-16	HUMAN OTC DRUG LABEL	4
Kaylaan Mint Toothpaste Tablet	Kaylaan LLC	2021-09-07	HUMAN OTC DRUG LABEL	2