BIOTENE
- Product NDC
- 0135-0557
- 11-digit product format
- 001350557
- Labeler code
- 0135
- Product ID
- 0135-0557_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 | 0135-0557 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | ||
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0135-0557 | 0135-0557-01 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0135-0557 | 0135-0557-02 | I | Inactivated by FDA | excluded / ndc_excluded.zip | 367a005e9d99… | 383a685ebd0f… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BIOTENE
- Brand name suffix
- Fresh Mint Original
- 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#
| NDC | Effective | Related label |
|---|---|---|
| 0135-0557-01 | 2024-11-05 | Drug Facts |
| 0135-0557-02 | 2024-11-05 | Drug Facts |
| 0135-0557-01 | 2024-07-30 | Drug Facts |
| 0135-0557-02 | 2024-07-30 | Drug Facts |
| 0135-0557-01 | 2024-01-30 | Drug Facts |
| 0135-0557-02 | 2024-01-30 | Drug Facts |
| 0135-0557-01 | 2022-08-24 | Drug Facts |
| 0135-0557-02 | 2022-08-24 | Drug Facts |
| 0135-0557-01 | 2022-07-29 | Drug Facts |
| 0135-0557-02 | 2022-07-29 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0557-01 | BIOTENEFresh Mint Original | 1 in 1 CARTON | PASTE | 1 | 10 | |
| 0135-0557-01 | BIOTENEFresh Mint Original | 121.9 g in 1 TUBE | PASTE | 121.9 | 10 | |
| 0135-0557-02 | BIOTENEFresh Mint Original | 19.8 g in 1 TUBE | PASTE | 19.8 | 10 | |
| 0135-0557-02 | BIOTENEFresh Mint Original | 1 in 1 CARTON | PASTE | 1 | 10 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0557-01 | GM - Gram | 0135-0557 | b4e1c4d8-3b80-4e80-b115-97c5a7ab00ef | 1 | 2015-07-20 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0557 | BIOTENE FRESH MINT ORIGINAL (SODIUM FLUORIDE) PASTE BIOTENE GENTLE MINT (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 10 | Current NDC, Legacy NDC, 4 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 |
|---|---|---|---|---|---|---|
| Saline | SALINE NASAL SPRAY | Dynarex Corporation | 3247ae7d-554f-baab-e063-6294a90aa3ec | 2026-08-25 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | WALMART INC. (see also Equate) | 584b38ce-d1ef-4ecc-a887-7c96e7f9669f | 2026-08-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Walgreens | fb93c7f6-e025-4cf2-9997-acfe9a0debdd | 2026-08-19 | Warnings | M022 |
| CVS Saline | NASAL | CVS PHARMACY | f02c41b0-c78e-41cd-aa4a-2756bbe92087 | 2026-08-19 | Warnings | M022 |
| Ludens Honey Licorice Throat Drops | MENTHOL | Prestige Brands Holdings, Inc. | 5dc2baec-a9ed-4f6b-a7ed-76a5d35739ac | 2026-08-19 | Warnings | M022 |
| Ludens Dual Relief | PECTIN AND MENTHOL | Prestige Brands Holdings, Inc. | d0213cb3-ec8e-40cc-82c9-694032f0490f | 2026-08-19 | Warnings | M022 |
| CVS Health Sore Throat Fast Relief Oral Anesthetic | PHENOL | CVS Pharmacy,Inc. | 4fb880db-2185-41ef-a5f9-8983a28d2c5b | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Cherry | PHENOL | CVS Pharmacy,Inc. | 887c68e0-ff44-4bad-b360-56fb99ed9c45 | 2026-08-17 | Warnings | M022 |
| CVS Sore Throat Menthol Flavor | PHENOL | CVS PHARMACY,INC. | 665be058-b965-4b78-80b0-dd8524180932 | 2026-08-17 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Harris Teeter, LLC | 7e5f175d-f0d6-4665-ac14-1873d6b99c80 | 2026-08-12 | Warnings | M022 |
| Gingicaine Gel Variety Pak | GINGICAINE GEL VARIETY PAK | Gingi-Pak a Division of the Belport | 62ed4ff3-18f6-5c67-e053-2991aa0a7792 | 2026-08-11 | Warnings | M022 |
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 5868c5a1-273f-f023-e063-6394a90ac9d8 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58690bb5-9604-26a4-e063-6394a90afdbe | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586918cf-7b13-5999-e063-6294a90a88a9 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586924a0-322d-5dc3-e063-6294a90a1556 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 58692e90-de74-52d3-e063-6394a90a9702 | 2026-08-06 | Warnings | M022 |
| Candee Caine Topical Anesthetic | BENZOCAINE | Top Quality Manufacturing, Inc. | 586937ae-46af-7066-e063-6294a90ae53e | 2026-08-06 | Warnings | M022 |
| Freshness Blueberry Toothpaste100g | FRESHNESS BLUEBERRY TOOTHPASTE 100G | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 586d1dba-87fc-b676-e063-6294a90a1470 | 2026-08-06 | 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 |
|---|---|---|---|---|---|---|---|---|
| 0135-0557-01 | 00135055701 | 1 TUBE in 1 CARTON (0135-0557-01) / 121.9 g in 1 TUBE | 1 tube | 2013-07-15 | 0000-00-00 | No | No | Current |
| 0135-0557-02 | 00135055702 | 1 TUBE in 1 CARTON (0135-0557-02) / 19.8 g in 1 TUBE | 1 tube | 2013-07-15 | 0000-00-00 | No | No | Current |