BIOTENE
- Product NDC
- 0135-0558
- 11-digit product format
- 001350558
- Labeler code
- 0135
- Product ID
- 0135-0558_95462fd1-5eb4-46ff-bf63-a5e610337bc6
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium fluoride
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2013-07-15
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.5 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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 | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 0135-0558 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0135-0558 | 0135-0558-01 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
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
- BIOTENE
- Brand name suffix
- Gentle Mint
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 1.5 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-11-05 | Drug Facts |
| 2024-07-30 | Drug Facts |
| 2024-01-30 | Drug Facts |
| 2022-08-24 | Drug Facts |
| 2022-07-29 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0558-01 | BIOTENEGentle Mint | 1 in 1 CARTON | PASTE | 1 | 10 | |
| 0135-0558-01 | BIOTENEGentle Mint | 121.9 g in 1 TUBE | PASTE | 121.9 | 10 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0558 | BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241107_1101c17f-c848-4cd5-a7cd-679b59dbe1bf.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 |
|---|---|---|---|---|---|---|
| CrystLCare Regeneration Plus | POTASSIUM NITRATE, SODIUM FLUORIDE | GreenMark Biomedical Inc. | 4f86d0a0-d73e-5605-e063-6394a90adb38 | 2026-09-14 | Warnings | M022 |
| Opalescence Whitening Sensitivity Relief | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 44e94663-895b-67da-e063-6394a90a5fe6 | 2026-09-09 | Warnings | M022 |
| Opalescence Sensitivity Relief Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | b5176a84-76a3-4ad0-a2e2-4997a12da9a5 | 2026-09-09 | Warnings | M022 |
| Opal by Opalescence Sensitivity | POTASSIUM NITRATE AND SODIUM FLUORIDE | Ultradent Products, Inc. | 5ffc0d14-0290-47bb-90e5-90a25a5acc28 | 2026-09-09 | Warnings | M022 |
| Saline | NASAL | Raritan Pharmaceuiticals Inc | 4b178e4e-a10f-4b75-8140-1f7548e203ad | 2026-09-09 | Warnings | M022 |
| SORE THROAT | PHENOL | Raritan Pharmaceuticals Inc | 43ce374a-824c-4034-bf04-c351b4d8015b | 2026-09-08 | Warnings | M022 |
| Colgate Optic White Stain Fighter Sens Relief | SODIUM FLUORIDE | Colgate-Palmolive Company | 6ec2fff7-df44-4302-be2d-97946c6cd66a | 2026-09-08 | Warnings | M022 |
| DRx Choice Sore Throat Menthol Flavor | PHENOL | RARITAN PHARMACEUTICALS INC | e3269b12-5c05-45a6-81f2-65d9f016c3aa | 2026-09-08 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | AmerisourceBergen (Good Neighbor Pharmacy) 46122 | 0733015b-e81a-4a62-82ad-dacaf3f163cb | 2026-09-02 | Warnings | M022 |
| KROGER Saline | NASAL | KROGER COMPANY | c84b242b-f46e-4ea8-a3c1-109a47644646 | 2026-09-02 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | ceb125d9-8c1b-498c-b0f0-f18756ede442 | 2026-09-01 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1c82b4-02b3-d456-e063-6294a90a16bb | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum PM Cream | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1cdaf4-3388-280c-e063-6294a90ac70f | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS SOOTHING COMFORT | HEXYLRESORCINOL | Reckitt Benckiser LLC | 91cd2964-5d83-4e40-bc18-e3e5462f454a | 2026-08-31 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-08-31 | Warnings | M022 |
| Orajel 4X Medicated Toothache and Gum | BENZALKONIUM CHLORIDE, BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 5a1b4133-0eac-2f8f-e063-6394a90af8f6 | 2026-08-28 | Warnings | M022 |
| LUDENS SUGAR FREE WILD CHERRY THROAT | PECTIN | Prestige Brands Holdings, Inc. | 274fc80c-e5b2-41c7-a119-287d6e8a2258 | 2026-08-28 | Warnings | M022 |
| Medline Peroxi Fresh Mouthwash | HYDROGEN PEROXIDE | Medline Industries, LP | ec7a9240-6c66-4471-b8b6-776e08a14fbc | 2026-08-27 | Warnings | M022 |
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-08-25 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416783 | sodium fluoride 0.24 % Toothpaste | PSN | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 1044547 | sodium fluoride 0.25 % Toothpaste | PSN | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 416783 | sodium fluoride 0.0024 MG/MG Toothpaste | SCD | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 1044547 | sodium fluoride 0.0025 MG/MG Toothpaste | SCD | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.13 % ) Toothpaste | SY | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.14 % ) Toothpaste | SY | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 416783 | sodium fluoride 0.24 % (fluoride ion 0.15 % ) Toothpaste | SY | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 1044547 | sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste | SY | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
| 1044547 | sodium fluoride 0.25 % Toothpaste | SY | 1101c17f-c848-4cd5-a7cd-679b59dbe1bf | 10 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0558-01 | 00135055801 | 1 TUBE in 1 CARTON (0135-0558-01) / 121.9 g in 1 TUBE | 1 tube | 2013-07-15 | 0000-00-00 | No | No | Current |