ORTHO GUARD
- Product NDC
- 63783-401
- 11-digit product format
- 637830401
- Labeler code
- 63783
- Product ID
- 63783-401_2a1d770f-d9a7-4980-a1f2-cf4df96d0f40
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM FLUORIDE
- Dosage form
- GEL, DENTIFRICE
- Route
- ORAL
- Labeler
- Massco Dental A Division of Dunagin Pharmaceuticals
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1989-01-01
- Substance
- SODIUM FLUORIDE
- Active strength
- 4.4 mg/10mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- ORTHO GUARD
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 4.4 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 63783-401-16 | ORTHO GUARD | 473 mL in 1 BOTTLE | GEL, DENTIFRICE | 473 | | 8 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 4 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 4 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 4 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 4 | |
| SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE | INACTIVE INGREDIENT | 593YOG76RN | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 4 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 63783-401 | ORTHO GUARD (SODIUM FLUORIDE) GEL, DENTIFRICE [MASSCO DENTAL A DIVISION OF DUNAGIN PHARMACEUTICALS] | 8 | Current NDC, Legacy NDC, 1 package rows | 20231218_8d3e0dd0-b584-413b-adf3-5c2d05ab72dd.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 63783-401-16 | 63783040116 | 473 mL in 1 BOTTLE (63783-401-16) | 473 ml | 1989-01-01 | 0000-00-00 | No | No | Current |