Parodontax
- Product NDC
- 0135-0655
- Requested package NDC
- 0135-0655-01
- 11-digit product format
- 001350655
- Labeler code
- 0135
- Product ID
- 0135-0655_42f314be-90cb-0204-e063-6394a90a22c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- stannous fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2025-12-15
- Substance
- STANNOUS FLUORIDE
- Active strength
- 1.5 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Brand name suffix
- Gum Strengthen and Protect
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| STANNOUS FLUORIDE | 1.5 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 |
|---|---|
| 3bb40ceb-841b-4a25-e063-6294a90ab897 | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0655-01 | ParodontaxGum Strengthen and Protect | 96.4 g in 1 TUBE | PASTE, DENTIFRICE | 96.4 | 2 | |
| 0135-0655-01 | ParodontaxGum Strengthen and Protect | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 2 |
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 |
|---|---|---|---|---|---|---|
| GuruNanda Anti-Cavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3b07b72f-4efc-eb0f-e063-6294a90a70a8 | 2026-01-19 | Warnings | M021 |
| GuruNanda Anticavity | SODIUM FLUORIDE | GURUNANDA, LLC | 3e90d516-3172-3c8d-e063-6294a90a394f | 2026-01-19 | Warnings | M021 |
| Hismile | PEACH ICED TEA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0eba92d1-cbdc-9c96-e063-6294a90a9afc | 2026-01-15 | Warnings | M021 |
| Hismile | COCONUT WHIP FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3cfb6-6bae-1682-e063-6394a90aca88 | 2026-01-15 | Warnings | M021 |
| Hismile | MANGO SORBET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef3f4f8-fdc4-2056-e063-6394a90a6fd7 | 2026-01-15 | Warnings | M021 |
| Hismile | SMOOTH MINT FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef41051-dfa0-b105-e063-6294a90a551f | 2026-01-15 | Warnings | M021 |
| Hismile | WATERMELON FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef43107-58ec-d4ee-e063-6294a90ad8d7 | 2026-01-15 | Warnings | M021 |
| Hismile | RED VELVET FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef56539-dc21-c6ea-e063-6394a90a5790 | 2026-01-15 | Warnings | M021 |
| Hismile | GRAPE BUBBLEGUM FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef6f8b5-8565-b364-e063-6294a90aabbc | 2026-01-15 | Warnings | M021 |
| Hismile | STRAWBERRY FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef766ae-754a-f185-e063-6294a90a3299 | 2026-01-15 | Warnings | M021 |
| Hismile | BANANA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef7be5b-df8f-9f32-e063-6394a90a4724 | 2026-01-15 | Warnings | M021 |
| Hismile | VANILLA FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | Hismile Pty Ltd | 0ef8d0ef-a051-f610-e063-6394a90a8537 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d40b98b-2e9a-d84a-e063-6294a90a2096 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d44863e-93be-2b80-e063-6294a90a4a9d | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d458ccc-8f1e-f9c8-e063-6294a90a8da4 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1d447939-fbf6-42f6-e063-6294a90af6d9 | 2026-01-15 | Warnings | M021 |
| HISMILE | SODIUM FLUORIDE | HISMILE PTY LTD | 1de591d9-9cab-e63d-e063-6394a90ac8eb | 2026-01-15 | Warnings | M021 |
| Ice Pop Flavor Sodium Fluoride Anticavity Toothpast | SODIUM FLUORIDE | HISMILE PTY LTD | 20e1603e-bcd1-6a5e-e063-6294a90ad1db | 2026-01-15 | Warnings | M021 |
| Hismile | CANDY CANE FLAVOR SODIUM FLUORIDE ANTICAVITY TOOTHPASTE | HISMILE PTY LTD | 1e725b7e-accc-f51c-e063-6394a90a455c | 2026-01-15 | Warnings | M021 |
| Enamelon Preventive Treatment | STANNOUS FLUORIDE | Premier Dental Products Company | 04c3f178-7905-404d-9ac2-67c453287ddf | 2026-01-13 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | PSN | 3bb40ceb-841b-4a25-e063-6294a90ab897 | 2 |
| 416784 | stannous fluoride 0.00454 MG/MG Toothpaste | SCD | 3bb40ceb-841b-4a25-e063-6294a90ab897 | 2 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.14 % ) Toothpaste | SY | 3bb40ceb-841b-4a25-e063-6294a90ab897 | 2 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.15 % ) Toothpaste | SY | 3bb40ceb-841b-4a25-e063-6294a90ab897 | 2 |
| 416784 | stannous fluoride 0.454 % (fluoride ion 0.16 % ) Toothpaste | SY | 3bb40ceb-841b-4a25-e063-6294a90ab897 | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 0135-0655-01 | 00135065501 | 1 TUBE in 1 CARTON (0135-0655-01) / 96.4 g in 1 TUBE | 1 tube | 2025-12-15 | No | No | Current |