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 |
|---|---|---|---|---|---|---|
| SIGNATURE CARE SORE THROAT CHERRY FLAVOR | PHENOL | SAFEWAY | 94a2c1b9-f462-4489-b84a-825a82835d30 | 2026-02-23 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | Meijer, Inc. | c9c17224-9304-403a-b6a1-9c8bd94e3d94 | 2026-02-19 | Warnings, Adverse reactions | M022 |
| AQUAFRESH CAVITY PROTECTION | SODIUM FLUORIDE | Haleon US Holdings LLC | 5484999c-8e6f-430d-99a5-6893a2489467 | 2026-02-16 | Warnings | M022 |
| AQUAFRESH EXTREME CLEAN WHITENING ACTION | SODIUM FLUORIDE | Haleon US Holdings LLC | aaff19d9-4ba5-462a-893b-7220feb25d6c | 2026-02-16 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | Walgreen Co. | 55807b18-42ed-45a7-845e-fcf7f5d70d04 | 2026-02-12 | Warnings, Adverse reactions | m022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | Walgreen Co. | 33223589-4ff4-4e4e-96da-6fa2e4d0f187 | 2026-02-12 | Warnings, Adverse reactions | M022 |
| PERIOSCIENCES SENSITIVE AO Pro | POTASSIUM NITRATE, SODIUM MONOFLUOROPHOSPHATE | PERIOSCIENCES LLC | acca8964-b575-468c-8b40-514dfbf50778 | 2026-02-09 | Warnings | M022 |
| Oral Sore Antiseptic | HYDROGEN PEROXIDE, MENTHOL | Retail Business Services, LLC | d46546d0-c6df-431a-8ab0-bc5013c084d7 | 2026-02-06 | Warnings, Adverse reactions | M022 |
| Hydrogen Peroxide 3 Percent | HYDROGEN PEROXIDE | EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC) | e19228e9-6f87-456e-a222-f979a234d589 | 2026-02-06 | Warnings | M022 |
| Listerine UltraClean Plus Whitening Protection Intense Antiseptic Antigingivitis/ Antiplaque Mouthwash | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 49d28991-b68f-ba16-e063-6394a90a0b13 | 2026-02-02 | Warnings | M022 |
| Sootheez Strawberry Lemonade | PECTIN | Primrose Candy Co. | 49e2b303-1018-cd13-e063-6394a90ae300 | 2026-02-02 | Warnings | M022 |
| Sootheez Berry Lemonade | PECTIN | Primrose Candy Co. | 49cee56f-c45f-6c79-e063-6294a90a5f8f | 2026-02-01 | Warnings | M022 |
| Sore Mouth Cleanser | HYDROGEN PEROXIDE | Rite Aid Corporation | 294418aa-640d-42be-ad07-de31da7a7ccc | 2026-01-30 | Warnings, Adverse reactions | M022 |
| Ora YoGu 4X Medicated Tooth and Gum Pain Reliever | MEDICATED TOOTH AND GUM PAIN RELIEVER | Kungpo Health Care & Herbal Center Inc | aa61ce6f-8336-4071-93b8-549fd22d1ae0 | 2026-01-22 | Warnings | M022 |
| Colgate Sensitive Complete Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Colgate-Palmolive Company | 866067b9-3dce-492d-ae99-1b807ecd56ff | 2026-01-22 | Warnings | M022 |
| Family Wellness Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR (Family Wellness) | 92fa0693-fca5-4bf9-8fce-a2d7e9ca37ea | 2026-01-21 | Warnings | M022 |
| Crest Pro-Health All Day Clean Breath | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 48eaca4c-19c2-2dd2-e063-6394a90a3e08 | 2026-01-21 | Warnings | M022 |
| Betadine Gargle | POVIDONE-IODINE | Atlantis Consumer Healthcare, Inc. | 5f0a3377-1398-2603-c632-f0d214bb88ec | 2026-01-21 | Warnings | M022 |
| ORAL PAIN RELIEF | BENZOCAINE | Universal Distribution Center LLC | e276ba37-46fb-4ed9-9ee1-c08a2a89704a | 2026-01-20 | Warnings | M022 |
| Equate Orasol | 20% BENZOCAINE | WAL-MART STORES INC. | 08404780-8252-4484-b1c3-8970803f74f8 | 2026-01-19 | Warnings | 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 |