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		2026-10-12
excluded package	package	82091-112	82091-112-10	I	Inactivated by FDA		2026-10-12

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 3 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
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
Freshness Coffee Toothpaste100g	FRESHNESS COFFEE TOOTHPASTE 100G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	586d79e9-2f0f-fa72-e063-6394a90a8dea	2026-08-06	Warnings	Exact identifier application number: M022
Freshness Flower Rose Toothpaste100g	FRESHNESS FLOWER ROSE TOOTHPASTE 100G	WORLD DENTISTS ASSOCIATION AMERICA LIMITED	586d7f5e-55e0-4fd2-e063-6294a90a92b6	2026-08-06	Warnings	Exact identifier application number: M022
PRO-SYS	ORAL WOUND CLEANSER	Forward Science Technologies LLC	c357c8f8-6fd6-c2f8-e053-2995a90a4023	2026-07-30	Warnings	Exact identifier application number: M022
Lornamead Natural White	FLUORIDE	Lornamead Products	9d7d08d7-8ca4-4b05-8b74-3bfa372b1608	2026-07-29	Warnings	Exact identifier application number: M022
Saline	NASAL	BEST CHOICE (VALU MERCHANDISERS COMPANY)	71485e82-bf54-4b8b-8dd2-2a0761534520	2026-07-17	Warnings	Exact identifier application number: M022
Good Neighbor Sore Throat Cherry Flavor	PHENOL	AMERISOURCE BERGEN	aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f	2026-07-13	Warnings	Exact identifier application number: M022
ABC Sore Throat Menthol Flavor	PHENOL	AMERISOURCE BERGEN	9d9baf58-4790-4ff4-a462-5eb70c0e80c5	2026-07-13	Warnings	Exact identifier application number: M022
Hydrogen Peroxide	HYDROGEN PEROXIDE	P & L Development, LLC	350b5f64-d152-40cb-b22f-98541f0e1b0a	2026-07-09	Warnings	Exact identifier application number: M022
Quality Choice Natural White	FLUORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	561a75c2-a40c-ba7c-e063-6294a90aa119	2026-07-08	Warnings	Exact identifier application number: M022
SALINE NASAL	SODIUM CHLORIDE	ALAINA HEALTHCARE PRIVATE LIMITED	ed30a7f9-7132-42da-9bed-63a9b1c80ab2	2026-07-07	Warnings	Exact identifier application number: M022
Dental system starter kit	US CONVENIENCE KIT (718907)	Dyson Technology Limited	5355b79b-711f-1a4a-e063-6394a90afc4b	2026-06-30	Warnings	Exact identifier application number: M022
Anticavity and sensitive peppermint	907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT	Dyson Technology Limited	5332ab71-d994-39cf-e063-6294a90a0d98	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55820ff9-7b4b-2bce-e063-6394a90a8b43	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	55806cb8-cf92-c4e5-e063-6394a90aaa2d	2026-06-30	Warnings	Exact identifier application number: M022
NebuClear MD Saline	NEBUCLEAR MD SALINE	Blue Echo Care LLC	5581d8e5-4105-e9da-e063-6394a90a316e	2026-06-30	Warnings	Exact identifier application number: M022
Corinz	CETYLPYRIDINIUM CHLORIDE	Sage Products, LLC	685b6023-89c4-417e-af2d-52e831855da1	2026-06-29	Warnings	Exact identifier application number: M022
Antiplaque solution	CETYLPYRIDINIUM CHLORIDE	Sage Products LLC	881d4d08-4b45-486a-93af-18c0e00a5b0e	2026-06-29	Warnings	Exact identifier application number: M022
GingiCaine gel, Cherry	GINGICAINE GEL, CHERRY FLAVOR	Gingi-Pak a Division of the Belport	6274d92e-c4e9-34fd-e053-2991aa0ae604	2026-06-29	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