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.
| 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.
| 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 |
|---|---|
| SODIUM FLUORIDE | .37 mg/440mg |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| 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 | 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 | 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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Fluoride Anti Caries 65g Coconut Whip Juicy Peach Mango Smoothie Summer Watermelon Hami Melom Cream Strawberries Blueberry | FLUORIDE ANTI CARIES TOOTHPASTE 65G COCONUT WHIP JUICY PEACH MANGO SMOOTHIE SUMMER WATERMELON HAMI MELOM CREAM STRAWBERRIES BLUEBERRY | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 3573f149-2af9-4c86-e063-6294a90a7b3f | 2025-05-18 | Warnings | M022 |
| Bubble Gum Flavor For Kids 25g 50g | BUBBLE GUM FLAVOR TOOTHPASTE FOR KIDS 25G 50G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 354c1eda-ec5b-a8c7-e063-6294a90a871d | 2025-05-16 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Safeway, Inc. | 8fe2f1df-3264-455d-b62c-953dce171c02 | 2025-05-16 | Warnings | M022 |
| Parodontax Active Gum Health Daily Mouthwash Breath Freshener | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 32b632bf-058d-447b-a7fb-a9dd05c1e2b8 | 2025-05-08 | Warnings | M022 |
| Parodontax Active Gum Health Clear Mint | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 444f931d-5e38-4cda-97ba-98aa0b5fe4f6 | 2025-05-08 | Warnings | M022 |
| Listerine Clinical Solutions Gum Health Icy Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 06e1122b-1100-43c0-e063-6394a90a2e78 | 2025-04-22 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Strategic Sourcing Services LLC | 5260258a-bb1e-43d6-bce1-70a38778a64a | 2025-04-14 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | TARGET Corporation | 93d0bb3a-51d3-44c8-8fb7-bdb82adfbb65 | 2025-04-14 | Warnings | M022 |
| Listerine Ultraclean Antiseptic Cool Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee467ec4-bd5e-644a-e053-2a95a90ac273 | 2025-04-10 | Warnings | M022 |
| Mouthwash | MENTHOL, METHYL SALICYLATE, THYMOL | Orazen Inc | 873c43df-1d46-359b-e053-2a91aa0a4319 | 2025-04-07 | Warnings | M022 |
| Sensodyne Complete Protection Extra Fresh | STANNOUS FLUORIDE | Haleon US Holdings LLC | e3cc3146-8aed-4f6b-a252-e379418c2b8d | 2025-03-26 | Warnings | M022 |
| Listerine Freshburst Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ee1e1df9-74c6-d24b-e053-2a95a90a43d3 | 2025-03-04 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | edb9e374-4dba-5823-e053-2a95a90a3da5 | 2025-03-03 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Good Sense (Geiss, Destin & Dunn, Inc.) | cfe9be26-e4a4-413c-a602-2f5948e3bb7a | 2025-03-03 | Warnings | M022 |
| LISTERINE Original Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 78e2e172-09a4-4bf1-9871-d099c49087be | 2025-02-28 | Warnings | M022 |
| WHITE GLO CHARCOAL SENSITIVE | POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE | WHITE GLO USA INC | a5edb7fd-c637-5447-e053-2995a90a5a6f | 2025-02-26 | Warnings | M022 |
| Glorysmile Toothpaste. | GLORYSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 2ef48156-904d-e42a-e063-6394a90a3cd0 | 2025-02-25 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Walgreens | c4e76d1d-1cee-4eeb-a2e4-6e9b1cac56fa | 2025-02-21 | Warnings | M022 |
| Sheffield Pain Relief | BENZOCAINE | Sheffield Pharmaceuticals LLC | e21abfdd-373d-42af-9535-fe1571382a65 | 2025-02-19 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Whole Foods Market | a2bb142e-8cbe-481e-bf4f-810ca6d14591 | 2025-02-12 | Warnings | M022 |
Packages#
| 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 |