botalab HERBAL COMPLETE TOOTH
- Product NDC
- 50555-201
- 11-digit product format
- 505550201
- Labeler code
- 50555
- Product ID
- 50555-201_51365ef7-ed95-2650-e063-6394a90ab89e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- PASTE, DENTIFRICE
- Route
- ORAL
- Labeler
- KMPHARMACEUTICAL CO., LTD.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2026-05-01
- Substance
- SODIUM FLUORIDE
- Active strength
- .22 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- 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
- botalab HERBAL COMPLETE TOOTH
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .22 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 245598 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 51365ef7-ed94-2650-e063-6394a90ab89e | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 50555-201-01 | botalab HERBAL COMPLETE TOOTH | 150 g in 1 TUBE | PASTE, DENTIFRICE | 150 | 1 | |
| 50555-201-02 | botalab HERBAL COMPLETE TOOTH | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 1 |
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 |
|---|---|---|---|---|---|---|
| Dentalclean Green Diamond Alcohol Free Mouthwash | SODIUM FLUORIDE 0.05% | Rabbit Indstria e Comrcio de Produtos de Higiene Pessoal Ltda | 5653aa33-4f0e-46b2-9be0-6219143556ec | 2025-07-14 | Warnings | M021 |
| Colgate Total Gum Protect Fresh Mint | STANNOUS FLUORIDE | COLGATE PALMOLIVE COMPANY | 570e3bd6-eede-4270-9d78-055aeb2b8c17 | 2025-07-14 | Warnings | M021 |
| OraPro Fluoride Anticavity | FLUORIDE TOOTHPASTE | Protegera, Inc. | 93b0181c-e29f-42f4-80f5-366463b68f09 | 2025-07-10 | Warnings | M021 |
| Enamur Fluoride AntiCavity Toothpast | FLUORIDE TOOTHPAST | Protegera, Inc | 557ced45-f54e-43d8-aa13-46f75b79367c | 2025-07-10 | Warnings | M021 |
| Super Strawberry | STRAWBERRY TOOTHPASTE | SuperMouth, LLC. | a8c2b68d-d28b-41c0-a383-cc706b25aa1a | 2025-07-05 | Warnings | M021 |
| Super Mint | SUPER MINT TOOTHPASTE | SuperMouth, LLC. | be0915f3-36c4-4200-9d15-704cfbd632b4 | 2025-07-05 | Warnings | M021 |
| Super Vanilla | VANILLA TOOTHPASTE | SuperMouth, LLC. | 3ddfe20a-86f1-4566-bb77-82c9749411f6 | 2025-07-05 | Warnings | M021 |
| Super Chocolate | CHOCOLATE TOOTHPASTE | SuperMouth, LLC. | 48607622-7c5e-4ddc-8d83-707f26c0553f | 2025-07-05 | Warnings | M021 |
| CURODONT REPAIR FLUORIDE PLUS | SODIUM FLUORIDE | CREDENTIS AG | 290c57b0-a562-0a51-e063-6294a90a0720 | 2025-06-23 | Warnings | M021 |
| KarlnHans Fresh Breath Jasmine Mint | SODIUM MONOFLUOROPHOSPHATE | PIGEON CORPORATION | 384863bd-b2cb-a46d-e063-6394a90a3ce2 | 2025-06-23 | Warnings | M021 |
| KarlnHans Fresh Breath Double Mint | SODIUM MONOFLUOROPHOSPHATE | PIGEON CORPORATION | 38487130-9508-a2c4-e063-6394a90aa323 | 2025-06-23 | Warnings | M021 |
| Crest Kids SparkleFun Bubblegum | SODIUM FLUORIDE | Procter & Gamble Manufactura, S. de R.L. de C.V. | 01f0e81a-03bf-e17f-e063-6394a90a7358 | 2025-06-12 | Warnings | M021 |
| Freshen Up | SODIUM FLUORIDE, POTASSIUM NITRATE | MKJ BRANDS LLC | 2ee626d1-6150-87db-e063-6294a90a64d8 | 2025-06-12 | Warnings | M021 |
| Colgate MaxFresh Citrus Fresh | SODIUM FLUORIDE | Colgate-Palmolive Company | 13a74642-51d2-493c-ae97-a54508546a74 | 2025-06-12 | Warnings | M021 |
| Colgate MaxFresh Watermelon Blast | SODIUM FLUORIDE | Colgate-Palmolive Company | 4f07f945-6594-40f4-bc19-6acc12c37cdd | 2025-06-12 | Warnings | M021 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 36994628-e5f3-3c35-e063-6294a90a609d | 2025-06-02 | Warnings | M021 |
| EUTHYMOL WHITENING SPECIAL GIFT SET | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 35bfa3fc-106e-aecc-e063-6294a90a7eb0 | 2025-05-22 | Warnings | M021 |
| EUTHYMOL WHITENING GIFT SET (40gX3) | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 369aa02f-c312-6a0d-e063-6294a90adaa5 | 2025-05-22 | Warnings | M021 |
| EUTHYMOL WHITENING TRAVEL | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 3596306e-858c-9bf7-e063-6294a90ac1d6 | 2025-05-20 | Warnings | M021 |
| Euthymol Whitening | SODIUM FLUORIDE | LG HOUSEHOLD & HEALTH CARE LTD. | 3582cc91-8c32-9f93-e063-6394a90a8792 | 2025-05-19 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 245598 | sodium fluoride 0.22 % Toothpaste | PSN | 51365ef7-ed94-2650-e063-6394a90ab89e | 1 |
| 245598 | sodium fluoride 0.0022 MG/MG Toothpaste | SCD | 51365ef7-ed94-2650-e063-6394a90ab89e | 1 |
| 245598 | sodium fluoride 0.22 % (fluoride 0.1 % ) Toothpaste | SY | 51365ef7-ed94-2650-e063-6394a90ab89e | 1 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 50555-201-01 | 50555020101 | 150 g in 1 TUBE | 150 g | Historical | |||
| 50555-201-02 | 50555020102 | 1 TUBE in 1 CARTON (50555-201-02) / 150 g in 1 TUBE (50555-201-01) | 1 tube | 2026-05-01 | No | No | Current |