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… |
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 |
|---|---|---|---|---|---|---|
| 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 |
| PRO-SYS | ORAL WOUND CLEANSER | Forward Science Technologies LLC | c357c8f8-6fd6-c2f8-e053-2995a90a4023 | 2026-07-30 | Warnings | M022 |
| Lornamead Natural White | FLUORIDE | Lornamead Products | 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608 | 2026-07-29 | Warnings | M022 |
| Made by Dentists Enamel 10 Fluoride Anticavity | POTASSIUM NITRATE, SODIUM FLUORIDE | Made By Dentists Inc | 3c62eab1-0cb6-4bdf-bfd4-c5afe734d036 | 2026-07-24 | Warnings | M022 |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | M022 |
| Good Neighbor Sore Throat Cherry Flavor | PHENOL | AMERISOURCE BERGEN | aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f | 2026-07-13 | Warnings | M022 |
| ABC Sore Throat Menthol Flavor | PHENOL | AMERISOURCE BERGEN | 9d9baf58-4790-4ff4-a462-5eb70c0e80c5 | 2026-07-13 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | P & L Development, LLC | 350b5f64-d152-40cb-b22f-98541f0e1b0a | 2026-07-09 | Warnings | M022 |
| Quality Choice Natural White | FLUORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 561a75c2-a40c-ba7c-e063-6294a90aa119 | 2026-07-08 | Warnings | M022 |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-07-06 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-07-03 | Warnings | M022 |
| Dental system starter kit | US CONVENIENCE KIT (718907) | Dyson Technology Limited | 5355b79b-711f-1a4a-e063-6394a90afc4b | 2026-06-30 | Warnings | M022 |
| Anticavity and sensitive peppermint | 907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT | Dyson Technology Limited | 5332ab71-d994-39cf-e063-6294a90a0d98 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55820ff9-7b4b-2bce-e063-6394a90a8b43 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55806cb8-cf92-c4e5-e063-6394a90aaa2d | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 5581d8e5-4105-e9da-e063-6394a90a316e | 2026-06-30 | Warnings | M022 |
| Corinz | CETYLPYRIDINIUM CHLORIDE | Sage Products, LLC | 685b6023-89c4-417e-af2d-52e831855da1 | 2026-06-29 | Warnings | M022 |
| Antiplaque solution | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | 881d4d08-4b45-486a-93af-18c0e00a5b0e | 2026-06-29 | 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 |