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… |
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
- 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 |
|---|---|---|---|---|---|---|
| Crest Pro-Health Breath Purify and Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d71ed31f-cc33-2fc3-e053-2995a90ad39b | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Clinical | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 0a295ee0-55c2-4f21-8f0a-70efc0e51694 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | d721e2cb-8f67-3d07-e053-2995a90ae65a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advantage | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | ddcd56fe-25d6-8195-e053-2a95a90a575a | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dc1f31-625d-a032-e053-2995a90a730d | 2026-01-08 | Warnings | M022 |
| Crest Pro Health Gum plus Bacteria Guard | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c598a4ab-5981-0068-e053-2a95a90af4fa | 2026-01-08 | Warnings | M022 |
| Oral B Gum Detoxify Special Care Rinse | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | c2dcdde4-5542-1f87-e053-2995a90a261c | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Fresh Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 62991165-ec81-48a8-e053-2991aa0a54f3 | 2026-01-08 | Warnings | M022 |
| Crest Gum Care | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 72f1a02f-1d02-7e83-e053-2a91aa0a7947 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Intense Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 6287bc3e-8b05-45d3-e053-2991aa0aaa10 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Multi-Protection Refreshing Clean Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 8867d791-7e93-4f39-aaaf-bfbee8296fd9 | 2026-01-08 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | HEB | a71c5259-cbcf-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| Topco Associates LLC Maximum Strength | FLUORIDE | Topco Associates LLC | 387d264c-90cc-5e67-e063-6394a90a713d | 2026-01-08 | Warnings | M022 |
| TopCare Sensitive Extra Whitening | POTASSIUM NITRATE, SODIUM FLUORIDE | TOPCO Assoc. LLC | 835f41cf-e920-7df7-e053-2a91aa0a4479 | 2026-01-08 | Warnings | M022 |
| Scope Icy Blast | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 164ed151-01d3-021a-e063-6294a90a0e51 | 2026-01-08 | Warnings | M022 |
| Crest Pro-Health Advanced Enamel Care | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 1660e7d7-5b8d-8aba-e063-6294a90a50d8 | 2026-01-08 | Warnings | M022 |
| Crest Deep Cleanse Germ Treatment | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 2d6b15d4-7827-ec2f-e063-6294a90a82c8 | 2026-01-08 | Warnings | M022 |
| Crest Scope Original | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 21eed451-9368-146c-e063-6294a90af62b | 2026-01-08 | Warnings | M022 |
| 3x Medicated Mouth Sore Gel | BENZOCAINE | HEB | a71c5259-cbd1-7566-e053-2995a90a2cb6 | 2026-01-08 | Warnings | M022 |
| HEB Extra Whitening | FLUORIDE | HEB | b76c3591-6383-4661-b3db-7a56b11202f7 | 2026-01-08 | 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 |