parodontax
- Product NDC
- 0135-0601
- 11-digit product format
- 001350601
- Labeler code
- 0135
- Product ID
- 0135-0601_c8ed1491-d424-49f6-b49e-56a938dc7328
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- stannous fluoride
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2016-12-19
- Substance
- STANNOUS FLUORIDE
- Active strength
- 1.1 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 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded product | product | 0135-0601 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… | ||
| 2022-08-30 03:57 UTC · source 2022-08-29 | excluded package | package | 0135-0601 | 0135-0601-01 | I | Inactivated by FDA | excluded / ndc_excluded.zip | fb8cb913e6d1… | eb8c232b6be0… |
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
- parodontax
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | 1.1 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 3FTR44B32Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 416784 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0f07aa1a-97be-44af-92d8-a10777e24e0a | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0135-0601-01 | 2024-01-30 | C162847 | 48780-1 | e4f33bdf-abcc-d8a0-e053-dadaa90a6e4e | Drug Facts |
| 0135-0601-01 | 2023-02-10 | C162847 | 48780-1 | e4f33bdf-abcc-d8a0-e053-dadaa90a6e4e | Drug Facts |
| 0135-0601-01 | 2022-07-29 | C162847 | 48780-1 | e4f33bdf-abcc-d8a0-e053-dadaa90a6e4e | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0601-01 | parodontax | 96.4 g in 1 TUBE | PASTE | 96.4 | 12 | |
| 0135-0601-01 | parodontax | 1 in 1 CARTON | PASTE | 1 | 12 | |
| 0135-0601-02 | parodontax | 2 in 1 CARTON | PASTE | 2 | 12 | |
| 0135-0601-02 | parodontax | 96.4 g in 1 TUBE | PASTE | 96.4 | 12 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0601-01 | GM - Gram | 0135-0601 | 5d289d50-b9f3-49b2-b927-2e1009c691c5 | 1 | 2017-03-06 |
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 |
|---|---|---|---|---|---|---|
| Lemon Glycerin | GLYCERIN | Dynarex Corporation | 99fc00ea-9d55-0380-e053-2995a90a2c0b | 2026-03-24 | Warnings | M022 |
| Vicks VapoCool Sore Throat | BENZOCAINE AND MENTHOL | The Procter & Gamble Manufacturing Company | 911a05de-cb3f-c1d2-e053-2995a90ae4be | 2026-03-23 | Warnings | M022 |
| Dual-FormulaToothpaste for sensitive teeth | DUAL-FORMULA TOOTHPASTE FOR SENSITIVE TEETH | Hangzhou Namei Zhikang Technology Co., Ltd. | 4d735f91-8abc-3a30-e063-6394a90a7639 | 2026-03-20 | Warnings | M022 |
| SmileCare Mouth Ulcer Gel | MENTHOL | Yantai Aien Biotechnology Co., Ltd. | 4d6db039-5b97-8f3f-e063-6294a90a9d85 | 2026-03-19 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f91e609-8ca5-0492-e053-2a95a90a85d0 | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f81ffa5-05fd-4eef-e053-2995a90aac3e | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f947366-9380-3fa9-e053-2a95a90ad49c | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f947672-4873-5546-e053-2a95a90a3c4b | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f9490c1-8bfe-3166-e053-2a95a90a7175 | 2026-03-17 | Warnings | M022 |
| Quala Topical Anesthetic Gel | BENZOCAINE | National Distribution & Contracting, Inc | 9f94b65d-47e3-9c6b-e053-2a95a90aa1f8 | 2026-03-17 | Warnings | M022 |
| BencoCaine Topical Anesthetic | BENZOCAINE | Benco Dental | 4d3e03ee-6e0f-c9ae-e063-6394a90a6f5b | 2026-03-17 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | 043c00a6-1346-7780-e063-6294a90a3d5a | 2026-03-12 | Warnings | M022 |
| ORAL PAIN RELIEF | BENZOCAINE | Nantong Health & Beyond Hygienic Products Inc. | a5f0be98-d47e-4307-8044-304a64db774b | 2026-03-11 | Warnings | M022 |
| SENSODYNE PRONAMEL Intensive Enamel Repair Whitening | POTASSIUM NITRATE AND SODIUM FLUORIDE | Haleon US Holdings LLC | a2f9d58b-671b-4427-a971-1fceff5f2323 | 2026-03-09 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | CVS Pharmacy, Inc. | a5dbaadf-76a8-4c48-af2d-f4455e9411f0 | 2026-03-09 | Warnings, Adverse reactions | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | Sam's West, Inc | 78a3e024-73da-40b7-9d9c-099fd6ca9b9e | 2026-03-03 | Warnings | M022 |
| Sore Throat | PHENOL GLYCERIN | CVS PHARMACY, INC | 9683bcfb-2f7e-48a4-aa79-500ee8df099a | 2026-03-02 | Warnings | M022 |
| Spring Gene Oil Pulling Sensitivity | POTASSIUM NITRATE | Health and Natural Beauty USA Corp | 294051e3-69ec-4190-8b03-fa34988376b7 | 2026-02-26 | Warnings | M022 |
| Lolleez Watermelon | PECTIN | BFY LLC | 4ba8af8b-5a17-8b8c-e063-6394a90a63f3 | 2026-02-25 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | H E B | f1450866-1be4-46d9-9fe4-52d699636b4f | 2026-02-24 | Warnings, Adverse reactions | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | PSN | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 12 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 12 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | 0f07aa1a-97be-44af-92d8-a10777e24e0a | 12 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0601-01 | 00135060101 | 1 TUBE in 1 CARTON (0135-0601-01) / 96.4 g in 1 TUBE | 1 tube | 2016-12-19 | 0000-00-00 | No | No | Current |
| 0135-0601-02 | 00135060102 | 2 TUBE in 1 CARTON (0135-0601-02) / 96.4 g in 1 TUBE | 2 tube | 2025-04-01 | No | No | Current |