NDC 54371-471
OraBrite
Sodium Fluoride
OraBrite is a Dental Paste, Dentifrice in the Human Otc Drug category. It is labeled and distributed by Oraline, Inc.. The primary component is Sodium Fluoride.
| Product ID | 54371-471_f22e9a97-1c45-472a-aee3-17c0a4223cbb |
| NDC | 54371-471 |
| Product Type | Human Otc Drug |
| Proprietary Name | OraBrite |
| Generic Name | Sodium Fluoride |
| Dosage Form | Paste, Dentifrice |
| Route of Administration | DENTAL |
| Marketing Start Date | 2011-10-31 |
| Marketing Category | OTC MONOGRAPH NOT FINAL / OTC MONOGRAPH NOT FINAL |
| Application Number | part356 |
| Labeler Name | Oraline, Inc. |
| Substance Name | SODIUM FLUORIDE |
| Active Ingredient Strength | 0 g/100g |
| NDC Exclude Flag | E |
| Listing Certified Through | 2017-12-31 |
Packaging
NDC 54371-471-03
78 g in 1 TUBE (54371-471-03)
| Marketing Start Date | 2011-10-31 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 54371-471-01 [54371047101]
OraBrite PASTE, DENTIFRICE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-10-31 |
| Inactivation Date | 2019-11-27 |
NDC 54371-471-03 [54371047103]
OraBrite PASTE, DENTIFRICE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-10-31 |
| Inactivation Date | 2019-11-27 |
NDC 54371-471-02 [54371047102]
OraBrite PASTE, DENTIFRICE
| Marketing Category | OTC monograph not final |
| Application Number | part356 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2011-10-31 |
| Inactivation Date | 2019-11-27 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .22 g/100g |
OpenFDA Data
| SPL SET ID: | 19e89dc7-465a-4603-870b-84ddfdf52478 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
NDC Crossover Matching brand name "OraBrite" or generic name "Sodium Fluoride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 54371-471 | OraBrite | OraBrite |
| 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 [OraBrite]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORABRITE 85247526 4361775 Live/Registered |
Oraline, Inc. 2011-02-21 |
 ORABRITE 85197473 4283447 Live/Registered |
Oraline, Inc. 2010-12-14 |
 ORABRITE 72300574 0873591 Dead/Expired |
FOREMOST-MCKESSON, INC. 1968-06-17 |
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