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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | WinCo Foods, LLC | 9417b340-942b-48bf-bbfd-4cd5154082b9 | 2025-02-12 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | b291811f-8fac-45e2-a9a2-b3ecc0813d0d | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | fea30599-5e3b-4163-9660-d41b3fcee143 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 3be68966-199c-481e-8b9e-e994c41fd96a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | ccdee0cc-2bc9-4165-a411-02f4f900d86a | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 0ca2b042-ea2c-4cbe-ae68-5a72a6bfa0b7 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 69c4dd1b-a0db-4495-bfc3-faffdfdf59bf | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | d5ef3e65-35e8-4323-9f33-3076b561e105 | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 746df21c-e92e-4a71-b1c6-baf99785a43e | 2025-01-29 | Warnings | M022 |
| NRG Topical Anesthetic | BENZOCAINE | IQ Dental Supply, LLC | 2345e614-c7b6-448c-8e07-31700bade91c | 2025-01-29 | Warnings | M022 |
| UltraCare Anesthetic Gel | BENZOCAINE | The Belport Company, Inc. DBA Gingi-Pak | 142062ca-6f8f-78d2-e063-6294a90a19d8 | 2025-01-29 | Warnings, Adverse reactions | M022 |
| CHLORASEPTIC MAX | MENTHOL AND BENZOCAINE | Prestige Brands Holdings, Inc. | edd12a2d-aa27-4f15-9ce6-862e4b6144c4 | 2025-01-23 | Warnings | M022 |
| meijer Sensitive FRESH MINT | POTASSIUM NITRATE, SODIUM FLUORIDE | Meijer, Inc. | bea36d55-1a5d-40c0-b422-92fb36043ee6 | 2025-01-23 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 159d412c-6d1a-45d4-88c0-8c93960f946e | 2025-01-21 | Warnings | M022 |
| SEACALL Mouthwash | MOUTHWASH | Guangdong Quadrant Ecological Technology Co., Ltd. | 2c1a7eed-6a7c-eeb2-e063-6394a90aafcc | 2025-01-19 | Warnings | M022 |
| BENZOCAINE Raspberry | BENZOCAINE | Darby Dental Supply, LLC | dd805400-26c5-4c18-ade2-821298233f9b | 2025-01-17 | Warnings | M022 |
| KAYLAAN | ZERO WASTE REFILL FOR TOOTHPASTE | Kaylaan LLC | c68fd8c7-7ec3-cc3f-e053-2995a90a4395 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | d22f7776-1b3c-4744-bcfe-8d9597218d73 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 9c6a26e8-1253-49f7-9ce2-45c0d39f05c5 | 2025-01-16 | Warnings | M022 |
| Pearson Topical Anesthetic | BENZOCAINE | Pearson Dental Supplies INC. | 48178733-7433-41ec-b178-1314e0edab1a | 2025-01-16 | 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 |