KAYLAAN
- Product NDC
- 82091-112
- Requested package NDC
- 82091-112-10
- 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 package | package | 82091-112 | 82091-112-10 | I | Inactivated by FDA | 2026-10-21 |
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 | Snapshot | Source SHA-256 |
|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | d630ba8d3edf… | 732f749b63fb… |
| 2025-08-27 00:01 UTC · source 2025-08-26 | f5e01cc5f278… | a2eaf40c39c3… |
| 2025-04-01 02:39 UTC · source 2025-03-31 | 2ef7874e63bc… | 57b86245f4fa… |
| 2025-03-28 20:22 UTC · source 2025-03-28 | a1b67e2a42f9… | c4cf2c586c0d… |
| 2025-03-22 03:12 UTC · source 2025-03-21 | cfe11265f3b6… | 090c488252e2… |
| 2025-03-10 12:48 UTC · source 2025-03-10 | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | ed331223b511… | 672a5bd82f5f… |
| 2025-01-11 03:41 UTC · source 2025-01-10 | 0efc9e666f02… | f202fb6c5f17… |
| 2024-11-09 02:27 UTC · source 2024-11-08 | ad56d346431e… | cc804d4bbf1e… |
| 2024-10-04 04:10 UTC · source 2024-10-03 | 367a005e9d99… | 383a685ebd0f… |
| 2024-07-10 04:00 UTC · source 2024-07-09 | 557ba5c1ecfa… | 9c80585c8c6e… |
| 2024-05-28 21:12 UTC · source 2024-05-28 | 8af77b9d5b6f… | d9bbb34c5368… |
| 2024-05-15 03:39 UTC · source 2024-05-14 | 834df4deac94… | adcc014656a3… |
| 2024-03-11 06:39 UTC · source 2024-03-08 | 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 |
|---|---|---|---|---|---|---|
| AHLO PRO Healthy Gums | CETYLPYRIDINIUM CHLORIDE | Gervest USA Inc | 4f5a0ccb-26e5-ebb6-e063-6394a90abbc5 | 2026-04-13 | Warnings | M022 |
| Crest Scope Original Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f1db6f4-acd7-a665-e063-6294a90a826b | 2026-04-10 | Warnings | M022 |
| Sore Throat | PHENOL GLYCERIN | Walgreens | 1e845299-178e-49ce-9d08-7e9d548a5a6d | 2026-04-09 | Warnings | M022 |
| Sore throat cherry | PHENOL | Walgreens | 67bed85e-e1e2-49ba-98d6-dfd4e1cd6856 | 2026-04-08 | Warnings | M022 |
| Health-Tec Topical Anesthetic | BENZOCAINE | Dental Health Products, Inc. | 5eb437c5-a2af-4c0d-b7b9-9ab7d093db85 | 2026-04-06 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | 269b9e7f-c5c8-4023-a3ea-e39040ade271 | 2026-04-06 | Warnings | M022 |
| Health-Tec Topical Anesthetic | BENZOCAINE | Dental Health Products, Inc. | c3fb6705-c647-4fe6-9aca-29735d01d8ea | 2026-04-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea | 2026-04-01 | Warnings | M022 |
| CloSYS Silver Healthy Gums | CETYLPYRIDINIUM CHLORIDE | Rowpar Pharmaceuticals, Inc. | 11fd3f31-ee0c-43d2-a856-929d1298277c | 2026-04-01 | Warnings | M022 |
| Crest Pro-Health Bold Fresh Breath | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 5692c0ce-a914-08c4-e063-6394a90adf15 | 2026-04-01 | Warnings | M022 |
| Anticavity Fluoride | SODIUM FLUORIDE AND ACIDULATED PHOSPHATE | Family Dollar (FAMILY WELLNESS) | 1666fff6-9a8b-40f9-ae53-914152db386b | 2026-04-01 | Warnings | M022 |
| Sodium Chloride Normal Salt | SODIUM CHLORIDE | TWIN MED LLC | 10230c8a-e5e5-44f1-b41d-80930899d6b9 | 2026-03-31 | Warnings | M022 |
| Sootheez Birthday Cake | PECTIN | Primrose Candy Co. | 4e5d8234-0521-0c8a-e063-6294a90ae62d | 2026-03-31 | Warnings | M022 |
| Sootheez Watermelon Mint | PECTIN | Primrose Candy Co. | 4e5e4342-4647-ef25-e063-6394a90a1d13 | 2026-03-31 | Warnings | M022 |
| PERIOGELX | HYDROGEN PEROXIDE | PERIO PROTECT, LLC | 4e5a67a0-f989-50df-e063-6394a90aae73 | 2026-03-31 | Warnings | M022 |
| Periogel | HYDROGEN PEROXIDE | PERIO PROTECT, LLC | 1f9686b1-eac2-65b7-e063-6394a90a74fb | 2026-03-31 | Warnings | M022 |
| PERIOGELX | HYDROGEN PEROXIDE | PERIO PROTECT, LLC | 1f7ecd75-bb59-2f4f-e063-6294a90ace84 | 2026-03-31 | Warnings | M022 |
| Baza Protect | ZINC OXIDE AND DIMETHICONE | Coloplast Corp | ed63df26-3879-46df-8e09-10be569b25be | 2026-03-31 | Warnings | M022 |
| Benzocaine 20% | BENZOCAINE 20% | PAI Holdings, LLC dba PAI Pharma | 7fbce9a5-00dc-4a4a-8709-ab752bdf2f59 | 2026-03-25 | Warnings | M022 |
| Kroger Extra Whitening | FLUORIDE | Kroger | e704c690-1383-4cd6-be85-28bdd9ff936b | 2026-03-24 | 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 |