NDC 63783-401
ORTHO GUARD
Sodium Fluoride
ORTHO GUARD is a Oral Gel, Dentifrice in the Human Prescription Drug category. It is labeled and distributed by Massco Dental A Division Of Dunagin Pharmaceuticals. The primary component is Sodium Fluoride.
| Product ID | 63783-401_270d4955-1afa-42ed-a3b1-9217973b60d7 |
| NDC | 63783-401 |
| Product Type | Human Prescription Drug |
| Proprietary Name | ORTHO GUARD |
| Generic Name | Sodium Fluoride |
| Dosage Form | Gel, Dentifrice |
| Route of Administration | ORAL |
| Marketing Start Date | 1989-01-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part355 |
| Labeler Name | Massco Dental A Division of Dunagin Pharmaceuticals |
| Substance Name | SODIUM FLUORIDE |
| Active Ingredient Strength | 0 mL/100mL |
| NDC Exclude Flag | E |
| Listing Certified Through | 2018-12-31 |
Packaging
NDC 63783-401-16
473 mL in 1 BOTTLE (63783-401-16)
| Marketing Start Date | 1989-01-01 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 63783-401-64 [63783040164]
ORTHO GUARD GEL, DENTIFRICE
| Marketing Category | OTC monograph final |
| Application Number | part355 |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Marketing Start Date | 1989-01-01 |
| Marketing End Date | 2011-10-29 |
NDC 63783-401-16 [63783040116]
ORTHO GUARD GEL, DENTIFRICE
| Marketing Category | OTC monograph final |
| Application Number | part355 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 1989-01-01 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | .044 mL/100mL |
OpenFDA Data
| SPL SET ID: | 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd |
| Manufacturer | |
| UNII |
NDC Crossover Matching brand name "ORTHO GUARD" or generic name "Sodium Fluoride"
| NDC | Brand Name | Generic Name |
|---|---|---|
| 63783-403 | ORTHO GUARD | ORTHO GUARD |
| 63783-400 | ORTHO GUARD | ORTHO GUARD |
| 63783-401 | ORTHO GUARD | ORTHO GUARD |
| 63783-402 | ORTHO GUARD | ORTHO GUARD |
| 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 [ORTHO GUARD]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ORTHO GUARD 86054684 not registered Dead/Abandoned |
Elmer Tolentino 2013-09-03 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.