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		2026-10-15
excluded package	package	82091-112	82091-112-10	I	Inactivated by FDA		2026-10-15

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…`

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: 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 36 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Acetaminophen	ACETAMINOPHEN	NuCare Pharmaceuticals,Inc.	872365ca-0c6b-550a-e053-2a91aa0ab25a	2024-06-14	Warnings	Exact identifier application number: M022
Amosan Oral Wound Cleanser Spearmint	SODIUM PERBORATE MONOHYDRATE	Vintage Brands Limited	7ac6c649-758f-4128-9920-466c0967b86a	2024-05-21	Warnings	Exact identifier application number: M022
Sensodyne	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	9e8e7b9f-3ccd-4935-b886-93f3a5045b67	2024-05-15	Warnings	Exact identifier application number: M022
Sensodyne Extra Whitening	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	1ed4a62b-f1d3-4740-8150-b94e02398740	2024-05-15	Warnings	Exact identifier application number: M022
Attitude Adult Fluoride-free - Sensitive - Spearmint	POTASSIUM NITRATE	9055-7588 Qubec Inc. DBA Attitude	46d5c908-f0e3-444c-9d96-461feef39137	2024-05-14	Warnings	Exact identifier application number: M022
sensodyne	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	16225f06-1d40-416a-aaec-7890e398fe4b	2024-05-13	Warnings	Exact identifier application number: M022
Sore Throat Cherry	PHENOL	QUALITY CHOICE (Chain Drug Marketing Association)	9162ae27-ddbb-4336-9655-487995919de4	2024-05-01	Warnings	Exact identifier application number: M022
BIO SPECTRA ATTITUDE	SODIUM FLUORIDE AND POTASSIUM NITRATE	9055-7588 Quebec Inc. DBA Attitude	42b79ec5-f37f-4dc9-9631-c8b1c153fe88	2024-04-26	Warnings	Exact identifier application number: M022
Quality Choice Oral Pain Relief	BENZOCAINE 20%, BENZALKONIUM CHLORIDE 1%	Quality Choice (CHAIN DRUG MARKETING ASSOCIATION)	162702b4-4bf7-8868-e063-6294a90a5921	2024-04-15	Warnings	Exact identifier application number: M022
Gelato Topical Anesthetic	BENZOCAINE	Mycone Dental Supply Co., Inc DBA Keystone Industries and Deepak Products Inc	9991de96-99a1-42f0-9ddd-e530ca9ceab1	2024-04-11	Warnings	Exact identifier application number: M022
Aquafresh Extreme Clean Pure Breath Action	SODIUM FLUORIDE	Haleon US Holdings LLC	462eb309-deca-4464-b13a-7ae314e53ede	2024-04-08	Warnings	Exact identifier application number: M022
Sore Throat Cherry	PHENOL	Family Dollar (FAMILY WELLNESS)	7806fac7-736e-44b0-baa2-42feb7237417	2024-03-27	Warnings	Exact identifier application number: M022
Sucrets	DYCLONINE HCL, MENTHOL, AND PECTIN	Insight Pharmaceuticals LLC	2a2839ea-11d3-4390-930d-0da912a9c6f5	2024-03-20	Warnings	Exact identifier application number: M022
Sucrets Sore Throat Wild Cherry	DYCLONINE HYDROCHLORIDE	Insight Pharmaceuticals LLC	da4967c7-ee18-42e7-8c97-8919f3bb1b7d	2024-03-20	Warnings	Exact identifier application number: M022
NATEAN Clean plus Sensitivity Relief	POTASSIUM NITRATE, SODIUM FLUORIDE	Haleon US Holdings LLC	cea6f992-8a44-4eb8-baea-97b7b181b227	2024-03-19	Warnings	Exact identifier application number: M022
NATEAN Clean and Whiten	SODIUM FLUORIDE	Haleon US Holdings LLC	71b95962-2693-49f5-94d2-f2a035b5e0c8	2024-03-19	Warnings	Exact identifier application number: M022
SENSODYNE Sensitivity and Gum Mint	STANNOUS FLUORIDE	Haleon US Holdings LLC	ed093acd-255c-40ff-a010-d276f5844453	2024-03-07	Warnings	Exact identifier application number: M022
SENSODYNE Sensitivity Gum and Enamel Mint	STANNOUS FLUORIDE	Haleon US Holdings LLC	d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2	2024-03-07	Warnings	Exact identifier application number: M022
Sensodyne True white	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	671f8f45-389c-4375-be43-f5500ee21a0e	2024-03-07	Warnings	Exact identifier application number: M022
Sensodyne Pronamel Strong and Bright Enamel Mint	POTASSIUM NITRATE AND SODIUM FLUORIDE	Haleon US Holdings LLC	be1ae382-0e01-4db8-90d7-fdadec2ff861	2024-03-06	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