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 | 2026-10-12 | ||
| 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.
| 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 |
|---|---|---|---|---|---|---|
| Crest Pro-Health Breath Purify and Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d71ed31f-cc33-2fc3-e053-2995a90ad39b | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Clinical | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 0a295ee0-55c2-4f21-8f0a-70efc0e51694 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d721e2cb-8f67-3d07-e053-2995a90ae65a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advantage | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | ddcd56fe-25d6-8195-e053-2a95a90a575a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dc1f31-625d-a032-e053-2995a90a730d | 2026-01-08 | Warnings | M022 |
| Crest Pro Health Gum plus Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c598a4ab-5981-0068-e053-2a95a90af4fa | 2026-01-08 | Warnings | M022 |
| Oral B Gum Detoxify Special Care Rinse | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dcdde4-5542-1f87-e053-2995a90a261c | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Fresh Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 62991165-ec81-48a8-e053-2991aa0a54f3 | 2026-01-08 | Warnings | M022 |
| Crest Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 72f1a02f-1d02-7e83-e053-2a91aa0a7947 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 6287bc3e-8b05-45d3-e053-2991aa0aaa10 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Multi-Protection Refreshing Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 8867d791-7e93-4f39-aaaf-bfbee8296fd9 | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | HEB | a71c5259-cbcf-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| Topco Associates LLC Maximum Strength | FLUORIDE | Topco Associates LLC | 387d264c-90cc-5e67-e063-6394a90a713d | 2026-01-08 | Warnings | M022 |
| TopCare Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | TOPCO Assoc. LLC | 835f41cf-e920-7df7-e053-2a91aa0a4479 | 2026-01-08 | Warnings | M022 |
| Scope Icy Blast | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 164ed151-01d3-021a-e063-6294a90a0e51 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advanced Enamel Care | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 1660e7d7-5b8d-8aba-e063-6294a90a50d8 | 2026-01-08 | Warnings | M022 |
| Crest Deep Cleanse Germ Treatment | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 2d6b15d4-7827-ec2f-e063-6294a90a82c8 | 2026-01-08 | Warnings | M022 |
| Crest Scope Original | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 21eed451-9368-146c-e063-6294a90af62b | 2026-01-08 | Warnings | M022 |
| 3x Medicated Mouth Sore Gel | BENZOCAINE | HEB | a71c5259-cbd1-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| HEB Extra Whitening | FLUORIDE | HEB | b76c3591-6383-4661-b3db-7a56b11202f7 | 2026-01-08 | 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 |