KAYLAAN
- Product NDC
- 82091-116
- 11-digit product format
- 820910116
- Labeler code
- 82091
- Product ID
- 82091-116_2b490a08-149f-76ab-e063-6394a90a084f
- 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
- 2021-09-13
- Substance
- SODIUM FLUORIDE
- Active strength
- .37 mg/440mg
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 |
|---|---|
| cb7f5f9b-4192-15e6-e053-2995a90a6457 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82091-116-01 | KAYLAAN | 74.3 mg in 1 BOX, UNIT-DOSE | TABLET, CHEWABLE | 74.3 | 3 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Listerine Gum Therapy Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | ed6889b6-58db-41cf-e053-2a95a90a7de2 | 2024-11-11 | Warnings | M022 |
| Listerine FreshBurst Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 62b5c3ee-01cc-4c4e-9f28-e7dafa7372d8 | 2024-11-11 | Warnings | M022 |
| Listerine Ultraclean Antiseptic Cool Mint | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | dd3729c2-fd05-4db0-a542-487bb0f9001f | 2024-11-11 | Warnings | M022 |
| Listerine Cool Mint Antiseptic | EUCALYPTOL, MENTHOL, UNSPECIFIED FORM, METHYL SALICYLATE, AND THYMOL | Kenvue Brands LLC | 9e97e4f8-80c2-44e0-862c-0dfca392a436 | 2024-11-11 | Warnings | M022 |
| Orajel 2X Medicated Gel | ORAL PAIN RELIEVER | Church & Dwight Co., Inc. | 262be295-4eaf-3136-e063-6294a90a7dcc | 2024-11-05 | Warnings | M022 |
| BIOTENE Fresh Mint Original | SODIUM FLUORIDE | Haleon US Holdings LLC | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 2024-11-05 | Warnings | M022 |
| biotene | SODIUM MONOFLUOROPHOSPHATE | Haleon US Holdings LLC | a47a6502-efb2-4072-9562-cbe293531c2b | 2024-11-04 | Warnings | M022 |
| Amosan Oral Wound Cleanser Cherry | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | a0e145c8-6b08-40be-ae4f-5678c4a78b1e | 2024-10-30 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043bfbc3-c33b-78b7-e063-6294a90a1a5a | 2024-10-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043bfbc3-c33a-78b7-e063-6294a90a1a5a | 2024-10-29 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043a3cb4-f560-0ffd-e063-6394a90a2ff6 | 2024-10-29 | Warnings | M022 |
| Amosan Oral Wound Cleanser Mint | SODIUM PERBORATE MONOHYDRATE | Vintage Brands Limited | be57ca56-834f-4170-a407-f193484d8b0a | 2024-10-29 | Warnings | M022 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Clean Mint | SODIUM FLUORIDE | Haleon US Holdings LLC | 817c0dad-d109-428e-adb5-3354604acc94 | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 1f3d68f6-afd6-42e7-b3e5-210228c8e7de | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals LLC | 0dd15227-6603-42ac-9a5f-f2dc49e0382a | 2024-10-28 | Warnings, Adverse reactions | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 0605d5d6-82bd-415e-b5cb-e273f934a4a7 | 2024-10-28 | Warnings | M022 |
| HurriCaine Topical Anesthetic Liquid | BENZOCAINE | Beutlich Pharmaceuticals, LLC | f70fa3fc-cd65-4a80-9efd-129e98fd3998 | 2024-10-28 | Warnings | M022 |
| Sore Throat Relief Menthol | PHENOL | Chain Drug Consortium | af661ef0-cdc3-4146-8ae5-59795aa49650 | 2024-10-28 | Warnings | M022 |
| Sore Throat Relief Cherry Flavor | PHENOL | Chain Drug Consortium | a9cf9829-4b70-44fa-9719-240b65c06724 | 2024-10-28 | Warnings | M022 |
| Ear Wax Removal Aid Drops | CARBAMIDE PEROXIDE | PHARMACY VALUE ALLIANCE, LLC | 85ae80c1-2bc2-4c90-9559-63510d03e739 | 2024-10-28 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82091-116-01 | 82091011601 | 74.3 mg in 1 BOX, UNIT-DOSE (82091-116-01) | 74.3 mg | 2021-09-13 | 0000-00-00 | No | No | Current |