KAYLAAN
- Product NDC
- 82091-113
- 11-digit product format
- 820910113
- Labeler code
- 82091
- Product ID
- 82091-113_2b4940da-237f-e433-e063-6294a90a47f0
- 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
- 2021-09-01
- 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 | 82091-113 | I | Inactivated by FDA | 2026-10-15 | ||
| excluded package | package | 82091-113 | 82091-113-01 | 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 | 82091-113-01 | 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 | 82091-113-01 | 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 | 82091-113-01 | 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 | 82091-113-01 | 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 | 82091-113-01 | 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 | 82091-113-01 | I | Inactivated by FDA | cdf11ea48f46… | ba0047e9e063… |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded product | product | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… | |
| 2025-02-02 03:52 UTC · source 2025-01-31 | excluded package | package | 82091-113-01 | U | Excluded because listing certification expired | 302b2466d912… | e7b80fea0513… |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded product | product | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… | |
| 2025-01-20 13:05 UTC · source 2025-01-20 | excluded package | package | 82091-113-01 | U | Excluded because listing certification expired | ed331223b511… | 672a5bd82f5f… |
| 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 | 82091-113-01 | U | Excluded because listing certification expired | 0efc9e666f02… | f202fb6c5f17… |
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 |
|---|---|
| 2b494372-de59-e462-e063-6294a90a08da | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 82091-113-01 | 2025-01-30 | C162847 | 48780-1 | 2cef2736-70c4-d83d-e063-dadaa90ab31f | Kaylaan Strawberry Toothpaste Tablet Refill |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 82091-113-10 | KAYLAAN | 74.3 mg in 1 BOTTLE, UNIT-DOSE | TABLET, CHEWABLE | 74.3 | 5 | |
| 82091-113-01 | KAYLAAN | 74.3 mg in 1 BOTTLE, UNIT-DOSE | TABLET, CHEWABLE | 74.3 | 4 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 82091-113 | KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC] | 5 | Current NDC, Legacy NDC, 1 package rows | 20250112_2b494372-de59-e462-e063-6294a90a08da.zip |
| 82091-113 | KAYLAAN (ZERO WASTE REFILL FOR TOOTHPASTE) TABLET, CHEWABLE [KAYLAAN LLC] | 4 | Current NDC, Legacy NDC, 1 package rows | 20230113_cb7d4735-42a0-3555-e053-2a95a90a5bc8.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 |
|---|---|---|---|---|---|---|
| Listerine Essential Care | SODIUM MONOFLUOROPHOSPHATE | Kenvue Brands LLC | 90b5c3d8-baa4-44ab-8f73-e177007f0219 | 2025-10-10 | Warnings | M022 |
| DuoCare Clinical Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Medline Industries, LP | 98e61cd5-7e29-7066-e053-2a95a90afa21 | 2025-10-10 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 40b756b7-ce1b-6482-e063-6294a90a0425 | 2025-10-09 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Gil Pharmaceutical Corp | 85053391-8d71-ab4f-e053-2991aa0a7e08 | 2025-10-09 | Warnings | M022 |
| Listerine Gum Therapy Mouthwash Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 40a0bdf3-1698-1449-e063-6394a90ab13d | 2025-10-08 | Warnings | M022 |
| Kalaya Breath Refresh | MOUTHWASH | Avaria Health and Beauty Corp | 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0 | 2025-10-08 | Warnings | M022 |
| Trader Joes | SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5% | TRADER JOE'S COMPANY | 159abeba-6da2-2643-e063-6394a90a730d | 2025-10-08 | Warnings | M022 |
| Family Wellness Oral Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR SERVICES INC | 105d87d6-9147-43d4-e063-6394a90a57ee | 2025-10-08 | Warnings | M022 |
| Equate Glistening Mint | SODIUM FLUORIDE | Walmart Inc. | 39ff21ee-a362-014e-e063-6294a90a0d91 | 2025-10-03 | Warnings | M022 |
| Mouth Sore Relief Professional Strength | BENZOCAINE | CVS Pharmacy | 1b7209f6-8368-47fa-8df2-b049613b8c1b | 2025-09-30 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Family Dollar (FAMILY WELLNESS) | 9db73da2-5b70-41e6-bcf9-caa7f1142024 | 2025-09-29 | Warnings | M022 |
| Esunix Oral Bacteriostatic Liquid | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47d7e1-b6ae-efd1-e063-6394a90a4602 | 2025-09-27 | Warnings | M022 |
| Chloraseptic Sore Throat Cherry | PHENOL | Prestige Brands Holdings, Inc. | d5d62f7a-8f92-4d42-a2fb-691f896f72fc | 2025-09-26 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Dextrum Laboratories Inc. | 3fa233dc-156c-1e95-e063-6294a90a8bbd | 2025-09-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Dextrum Laboratories Inc. | cb027ab8-4175-4cc0-a73e-991dfb113df9 | 2025-09-23 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 3f872924-0c44-267b-e063-6394a90a1a67 | 2025-09-23 | Warnings | M022 |
| Dental Relief | BENZOCAINE | Cintas Corporation | 0f40f775-797e-43cf-88c9-00eea666494f | 2025-09-23 | Warnings | M022 |
| Seavue Anti-caries Gel | SODIUM FLUORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4c6086-b96d-8fa4-e063-6294a90ad800 | 2025-09-21 | Warnings | M022 |
| Seavue Dental Desensitizer | POTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47f399-1a14-5264-e063-6394a90aeb1c | 2025-09-20 | Warnings | M022 |
| Povi-One | POVIDONE-IODINE 10% TOPICAL | Elevate Oral Care | 27c29a33-d1cc-d72f-e063-6394a90a4d45 | 2025-09-19 | Warnings | M022 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 82091-113-01 | 82091011301 | 74.3 mg in 1 BOTTLE, UNIT-DOSE (82091-113-01) | 74.3 mg | 2021-09-13 | 0000-00-00 | No | No | Current |
| 82091-113-10 | 82091011310 | 74.3 mg in 1 BOTTLE, UNIT-DOSE (82091-113-10) | 74.3 mg | 2021-09-13 | No | No | Current |