Pro-Den Rx
- Product NDC
- 59883-821
- 11-digit product format
- 598830821
- Labeler code
- 59883
- Product ID
- 59883-821_8349a34e-ac6f-79c3-e053-2a91aa0a857a
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL
- Route
- ORAL
- Labeler
- DEN-MAT HOLDINGS, LLC
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2008-11-21
- Marketing end
- 0000-00-00
- Substance
- SODIUM FLUORIDE
- Active strength
- 4 g/g
- NDC exclude flag
- No
- Listing certified through
- 2020-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| CARBOXYMETHYLCELLULOSE | INACTIVE INGREDIENT | 05JZI7B19X | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| DIATOMACEOUS EARTH | INACTIVE INGREDIENT | 2RF6EJ0M85 | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | PRO-DEN RX (SODIUM FLUORIDE) GEL [ZILA THERAPEUTICS, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59883-821 | PRO-DEN RX (SODIUM FLUORIDE) GEL [DEN-MAT HOLDINGS, LLC] | 2 | Legacy NDC | 20190308_bcda408e-4e54-4909-aae6-97b26b40830b.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 59883-821-02 | 59883082102 | 1 TUBE in 1 CARTON (59883-821-02) > 56 g in 1 TUBE | 1 tube | 2008-11-21 | 0000-00-00 | No | No | Current |