NDC 61041-211
XEROSTOM
Sodium Fluoride
XEROSTOM is a Oral Mouthwash in the Human Otc Drug category. It is labeled and distributed by Bio Cosmetics. The primary component is Sodium Fluoride.
| Product ID | 61041-211_07ceb03e-9994-498c-a020-d7f17f9da10b |
| NDC | 61041-211 |
| Product Type | Human Otc Drug |
| Proprietary Name | XEROSTOM |
| Generic Name | Sodium Fluoride |
| Dosage Form | Mouthwash |
| Route of Administration | ORAL |
| Marketing Start Date | 2013-11-15 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Labeler Name | Bio Cosmetics |
| Substance Name | SODIUM FLUORIDE |
| Active Ingredient Strength | 1 mg/mL |
| NDC Exclude Flag | N |
| Listing Certified Through | 2019-12-31 |
Packaging
NDC 61041-211-09
1 BOTTLE in 1 CARTON (61041-211-09) > 250 mL in 1 BOTTLE
| Marketing Start Date | 2013-11-15 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 61041-211-09 [61041021109]
XEROSTOM MOUTHWASH
| Marketing Category | OTC monograph final |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2013-11-15 |
NDC 61041-211-31 [61041021131]
XEROSTOM MOUTHWASH
| Marketing Category | OTC monograph final |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2015-02-06 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .559 mg/mL |
OpenFDA Data
| SPL SET ID: | 28a1a9c9-9c9a-4e43-b12c-85ded19ed926 |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "XEROSTOM" or generic name "Sodium Fluoride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 61041-211 | XEROSTOM | XEROSTOM |
| 61041-212 | XEROSTOM | XEROSTOM |
| 0135-0234 | AQUAFRESH | sodium fluoride |
| 0126-0021 | Colgate | SODIUM FLUORIDE |
| 0126-0034 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride | SODIUM FLUORIDE |
| 0126-0032 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Mint Fluoride | SODIUM FLUORIDE |
| 0041-1421 | Oral-B | Sodium Fluoride |
| 0126-0131 | Phos-Flur | Sodium Fluoride |
| 0126-0135 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0138 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0139 | Phos-Flur Ortho Defense | SODIUM FLUORIDE |
| 0126-0074 | PrevidDent 5000 Booster Plus Spearmint | Sodium Fluoride |
| 0126-0016 | PreviDent | Sodium fluoride |
| 0126-0075 | PreviDent | Sodium fluoride |
| 0126-0076 | PreviDent | Sodium fluoride |
| 0126-0179 | PreviDent | Sodium Fluoride |
| 0126-0286 | PreviDent | Sodium Fluoride |
| 0126-0287 | PreviDent | Sodium Fluoride |
| 0126-0072 | PreviDent 5000 Booster Plus Fruitastic | Sodium Fluoride |
| 0126-0033 | PreviDent Alcohol Free | Sodium Fluoride |
| 0126-0088 | PreviDent Fresh Mint | Sodium Fluoride |
| 0126-0289 | PreviDent OrthoDefense | SODIUM FLUORIDE |
| 0126-0288 | PreviDent Very Berry | Sodium Fluoride |
Trademark Results [XEROSTOM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 XEROSTOM 78274022 2869566 Live/Registered |
Bio Cosmetics, S.L. 2003-07-14 |
 XEROSTOM 78162753 2824989 Live/Registered |
Bio Cosmetics, S.L. 2002-09-11 |
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