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 |
|---|---|---|---|---|---|---|
| S.T.37 | HEXYLRESORCINOL | NUMARK BRANDS, INC | 7d7acca2-aa8a-5272-e813-faab039cc798 | 2025-12-15 | Warnings | M022 |
| Esunix Oral Bacteriostatic Gel | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4ee467-8142-8cb7-e063-6394a90aa7f7 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999851ac-925c-7d1f-e053-2a95a90a240b | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For Toothache and Gum | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99a2b061-0875-59a4-e053-2995a90ab373 | 2025-12-12 | Warnings | M022 |
| Orajel Antiseptic Rinse For All Mouth Sores | HYDROGEN PEROXIDE AND MENTHOL | Church & Dwight Co., Inc. | 06188d36-0d60-6ae6-e054-00144ff8d46c | 2025-12-12 | Warnings | M022 |
| Orajel 3X Medicated For All Mouth Sores | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 99b589ac-9833-fb60-e053-2995a90a0935 | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated For Toothache and Gum, Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999aa7b9-bf9e-9285-e053-2a95a90a345b | 2025-12-12 | Warnings | M022 |
| Orajel 4X Medicated PM For Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 999cff2b-c23e-5abe-e053-2a95a90a7569 | 2025-12-12 | Warnings | M022 |
| Benzoin Compound Tincture | BENZOIN RESIN | Humco Holding Group, Inc. | a893a232-2ea8-4e0d-8cbf-7f5040b3be2e | 2025-12-11 | Warnings | M022 |
| Listerine Original Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 456d45e8-bf6d-31c4-e063-6394a90a5c00 | 2025-12-10 | Warnings | M022 |
| Oral pain relief | BENZOCAINE | ALAINA HEALTHCARE PRIVATE LIMITED | d98c1b2f-fe75-4d52-b082-1abb7628c59e | 2025-12-09 | Warnings | M022 |
| HEB Sensitive Extra Whitening Twin | SODIUM FLUORIDE | HEB | 41d5ae3e-51c1-263b-e063-6394a90a3312 | 2025-12-08 | Warnings | M022 |
| CankerMelts | BENZOCAINE | Quest Products, LLC | 070dae82-14c2-66d2-e063-6394a90ab259 | 2025-12-04 | Warnings | M022 |
| Sore Throat ReadyInCase | PHENOL | P & L Development, LLC | 2fb3d17e-8ca3-4edb-8b82-4b484f42616e | 2025-12-03 | Warnings | M022 |
| Listerine Cool Mint Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 44f2b66a-26ae-1044-e063-6394a90a9ab6 | 2025-12-02 | Warnings | M022 |
| Sensodyne Fresh Clean | STANNOUS FLUORIDE | Haleon US Holdings LLC | 2d433ac1-3ddf-a2f4-e063-6394a90a91f8 | 2025-12-01 | Warnings | M022 |
| Walgreens Saline | NASAL | WALGREEN COMPANY | 147e45c8-1e71-4c06-89f1-42e9f9683366 | 2025-12-01 | Warnings | M022 |
| EELHOE Probiotic Bright White Fresh | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 425cec0e-aa74-5341-e063-6294a90ac86b | 2025-11-27 | Warnings | M022 |
| EELHOE 5 Days Tooth Powder | GLYCERIN | Shantou Eelhoe Daily Chemical Technology Co., Ltd. | 42f98b14-d1d5-4af8-e063-6294a90a8f67 | 2025-11-27 | Warnings | M022 |
| JAYSUING Colour Corrector | GLYCERIN | Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd. | 425d9c23-a692-3c62-e063-6294a90a9404 | 2025-11-27 | 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 |