biotene
- Product NDC
- 0135-0577
- 11-digit product format
- 001350577
- Labeler code
- 0135
- Product ID
- 0135-0577_c26f08a5-fa67-417e-8499-015edb65f7f8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium monofluorophosphate
- Dosage form
- PASTE
- Route
- ORAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-09-01
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- 1.4 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 | Package NDC | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded product | product | 367a005e9d99… | 383a685ebd0f… | |
| 2024-10-04 04:10 UTC · source 2024-10-03 | excluded package | package | 0135-0577-01 | 367a005e9d99… | 383a685ebd0f… |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded product | product | 8dfbde2a14a4… | c9ff85d89658… | |
| 2021-12-27 23:28 UTC · source 2021-12-27 | excluded package | package | 0135-0577-01 | 8dfbde2a14a4… | c9ff85d89658… |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded product | product | e2bbac7714bc… | 27bdfed8d636… | |
| 2020-12-18 03:04 UTC · source 2020-12-17 | excluded package | package | 0135-0577-01 | e2bbac7714bc… | 27bdfed8d636… |
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
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | 1.4 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C810JCZ56Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 545626 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| a47a6502-efb2-4072-9562-cbe293531c2b | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| Effective | Related label |
|---|---|
| 2024-11-05 | Drug Facts |
| 2024-07-30 | Drug Facts |
| 2024-01-30 | Drug Facts |
| 2022-01-07 | Drug Facts |
| 2020-09-27 | Drug Facts |
| 2020-09-25 | Drug Facts |
| 2020-07-22 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0577-01 | biotene | 1 in 1 CARTON | PASTE | 1 | 9 | |
| 0135-0577-01 | biotene | 121.9 g in 1 TUBE | PASTE | 121.9 | 9 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| GingiCaine Gel, Mint Julep | GINGICAINE GEL, MINT JULEP FLABVOR | Gingi-Pak a Division of the Belport | 6285fe10-08ba-8044-e053-2991aa0a8e8b | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Pina Colada | GINGICAINE GEL, PINA COLADA FLAVOR | Gingi-Pak a Division of the Belport | 6284e1fe-be33-69bf-e053-2991aa0a90ab | 2026-06-29 | Warnings | M022 |
| GingiCaine Gel, Chocolate Mint | GINGICAINE GEL, CHOCOLATE MINT FLAVOR | Gingi-Pak a Division of the Belport | 6285c4f2-c139-49a9-e053-2991aa0a2b03 | 2026-06-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Bellport Company, Inc. dba Gingi-Pak | f5dd8fa8-0b6a-5a30-e053-2995a90ad194 | 2026-06-26 | Warnings | M022 |
| GingiCaine Gel | GINGICAINE GEL BANANA FLAVOR | Gingi-Pak a Division of the Belport | 62857d06-a829-4efa-e053-2991aa0a6d15 | 2026-06-25 | Warnings | M022 |
| GingiCaine Gel, Cotton Candy Flavor | GINGICAINE GEL, COTTON CANDY FLAVOR | Gingi-Pak a Division of the Belport | 628515a5-175f-ac2c-e053-2991aa0a19ce | 2026-06-25 | Warnings | M022 |
| Perox-A-Mint Solution | HYDROGEN PEROXIDE | Sage Products, LLC | 50823ff5-ad08-4449-bc4a-9a8ae25ec0d5 | 2026-06-24 | Warnings | M022 |
| Antiseptic Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | efff8bae-154d-46bc-8dd4-716800425663 | 2026-06-24 | M022 | |
| Anbesol Maximum Strength | BENZOCAINE | Foundation Consumer Brands | 8c6ac499-9bd2-4ea5-9f26-df7947bff4a6 | 2026-06-22 | Warnings | M022 |
| Anbesol Maximum Strength | BENZOCAINE | Foundation Consumer Brands | dcc37403-0192-4658-bb7a-059273ce0047 | 2026-06-22 | Warnings | M022 |
| Toothache | POLYHEXAMETHYLENE BIGUANIDE HYDROCHLORIDE | Guchutang Biotechnology (Longyan) Co., Ltd | 54ad2ceb-272f-e5ba-e063-6394a90aec5f | 2026-06-20 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Delon Laboratories (1990) Ltd | d4aa09bf-8207-47dd-bc42-01e660da9438 | 2026-06-16 | Warnings | M022 |
| TideFresh MOUTH SORE AND TOOTHACHE | BENZOCAINE 20% MOUTH SORE AND TOOTHACHE | Wenzhou Yuyuan Pharmaceutical Co., Ltd. | 541e1814-c00e-efdf-e063-6394a90a41a1 | 2026-06-13 | Warnings | M022 |
| Chloraseptic Sore Throat Max | PHENOL AND GLYCERIN | Prestige Brands Holdings, Inc. | 882c940c-b3c3-4aa4-8d64-e4260f066ff4 | 2026-06-08 | Warnings | M022 |
| Orazen | SODIUM MONOFLUOROPHOSPHATE | Orazen Inc | fa5b6bd8-443f-79e7-e053-6394a90a5513 | 2026-06-03 | Warnings | M022 |
| Fishermans Friend Mixed Berry | MENTHOL | Lofthouse of Fleetwood | 53391c4d-ee2d-ade3-e063-6394a90ac77d | 2026-06-01 | Warnings | M022 |
| Orajel Medicated for Toothache and Gum, Liquid | BENZOCAINE AND MENTHOL | Church & Dwight Co., Inc. | ac3d605d-241d-1a6f-e053-2a95a90ae391 | 2026-06-01 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | BENZOCAINE AND MENTHOL, UNSPECIFIED FORM | Reckitt Benckiser LLC | 6140d487-d87c-4954-9247-83492bcc5738 | 2026-05-27 | Warnings | M022 |
| Dolodent Maximum Strength | BENZOCAINE | Pharmadel LLC | 351ecc2b-cc1a-2bbf-e063-6394a90a5c14 | 2026-05-26 | Warnings | M022 |
| MOUTH ULCER | PANTHENOL | Guangzhou Shengli Shidai Cosmetics Co., Ltd. | 5264f81c-bffe-4f6d-e063-6394a90ae3bf | 2026-05-22 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | a47a6502-efb2-4072-9562-cbe293531c2b | 9 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | a47a6502-efb2-4072-9562-cbe293531c2b | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | a47a6502-efb2-4072-9562-cbe293531c2b | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | a47a6502-efb2-4072-9562-cbe293531c2b | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | a47a6502-efb2-4072-9562-cbe293531c2b | 9 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | a47a6502-efb2-4072-9562-cbe293531c2b | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0577-01 | 00135057701 | 1 TUBE in 1 CARTON (0135-0577-01) / 121.9 g in 1 TUBE | 1 tube | 2016-09-01 | 0000-00-00 | No | No | Current |