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
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- KAYLAAN
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | .37 mg/440mg |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| 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 table| 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 |
Packages#
Package NDC, 11-digit format, Description table| 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 |