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 |
|---|---|---|---|---|---|---|
| Crest Kids Advanced Color Changing | SODIUM MONOFLUOROPHOSPHATE | Procter & Gamble Manufactura, S de R.L. de C.V. | fc86b98e-d556-4769-e053-6394a90afc6e | 2026-01-08 | Warnings | M022 |
| Care One Maximum Strength | FLUORIDE | American Sales | 1b6618ea-6533-41d7-be2c-13bb9e108dc5 | 2026-01-08 | Warnings | M022 |
| equate Sensitive | POTASSIUM NITRATE, SODIUM FLUORIDE | Wal-Mart Stores Inc | 79899b59-3a16-6504-e053-2991aa0a895a | 2026-01-08 | Warnings | M022 |
| Crest Kids Advanced Color Changing | SODIUM MONOFLUOROPHOSPHATE | Procter & Gamble Manufactura, S de R.L. de C.V. | 451283d3-78b0-8361-e063-6294a90a1fd5 | 2026-01-08 | Warnings | M022 |
| CVS Maximum Strength | BENZOCAINE | CVS Pharmacy | 8691d6b6-741e-47b2-8332-76742b34715f | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Gel | BENZOCAINE | Publix Super Markets INC | 16eb9d15-dba3-36e6-e063-6394a90ab859 | 2026-01-08 | Warnings | M022 |
| Toothache and Gum Relief | BENZOCAINE, MENTHOL | CVS Pharmacy | 814ec7bf-f825-1095-e053-2a91aa0aee59 | 2026-01-08 | Warnings | M022 |
| Lemon | GLYCERIN | Sion Biotext Medical Ltd | dbd7ed86-1b92-4471-827a-89f3afa1b0dc | 2026-01-08 | Warnings | M022 |
| Sootheez Organic Wild Cherry | PECTIN | BFY LLC | 47baa2a8-270c-fa07-e063-6394a90a97f6 | 2026-01-06 | Warnings | M022 |
| Parodontax Gum Strengthen and Protect | CETYLPYRIDINIUM CHLORIDE | Haleon US Holdings LLC | 3bb378c8-14b2-aa13-e063-6294a90a4db3 | 2026-01-05 | Warnings | M022 |
| MySweetSmile Toothpaste. | MYSWEETSMILE TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 478baf87-9276-7288-e063-6294a90a9e8e | 2026-01-04 | Warnings | M022 |
| MySweetSmile Mango Toothpaste. | MYSWEETSMILE MANGO TOOTHPASTE. | Jiangxi Dentalbright Technology Co., Ltd | 478cbdeb-28e1-fa56-e063-6294a90af124 | 2026-01-04 | Warnings | M022 |
| Smile Paint | SODIUM FLUORIDE | JABBER JAW KIDS TOOTHPASTE LLC | a7463b5c-53b2-4353-a5ea-800fbd7bd17d | 2026-01-02 | Warnings | M022 |
| Dentek Canker Cover | MENTHOL | Bershtel Enterprises | 2669183c-7a58-037e-e054-00144ff88e88 | 2025-12-31 | Warnings | M022 |
| AutoBrush strawberry | SODIUM FLUORIDE | Lander Enterprises, LLC | 05929148-bffe-439f-a9d4-3170816c0fa2 | 2025-12-31 | Warnings | M022 |
| AutoBrush Watermelon | SODIUM FLUORIDE | Lander Enterprises, LLC | 37a4e712-e3b5-42f6-971c-98dea4b8dd06 | 2025-12-31 | Warnings | M022 |
| AutoBrush Mint | SODIUM FLUORIDE | Lander Enterprises, LLC | 6bcd35f5-18ea-4fc8-84cd-06db73f38a1e | 2025-12-31 | Warnings | M022 |
| AutoBrush Bubblegum | SODIUM FLUORIDE | Lander Enterprises, LLC | e7bf7e31-650d-4a1c-9100-48722344b201 | 2025-12-31 | Warnings | M022 |
| Normal Salt | SODIUM CHLORIDE | GRAXCELL PHARMACEUTICAL, LLC | f3f09817-8a38-4aa1-956b-69d9cf695074 | 2025-12-25 | Warnings | M022 |
| Sensitive Mint Tooth-paste | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | 1e5e8b24-8304-482c-ae80-73effcc345da | 2025-12-23 | 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 |