Ionite APF
- Product NDC
- 53045-201
- 11-digit product format
- 530450201
- Labeler code
- 53045
- Product ID
- 53045-201_205e68a0-f45e-4339-9eea-512e216e05ae
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL
- Route
- DENTAL; ORAL
- Labeler
- Dharma Research, inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2013-01-01
- Substance
- SODIUM FLUORIDE
- Active strength
- 10.241 g/490g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Ionite APF
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 10.241 g/490g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 245593 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 53045-201-08 | Ionite APF | 245 g in 1 BOTTLE | GEL | 245 | | 3 |
| 53045-201-17 | Ionite APF | 490 g in 1 BOTTLE | GEL | 490 | | 3 |
| 53045-201-38 | Ionite APF | 3724 g in 1 BOTTLE | GEL | 3724 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| .ALPHA.-TOCOPHEROL ACETATE, DL- | INACTIVE INGREDIENT | WR1WPI7EW8 | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| HYDROFLUORIC ACID | INACTIVE INGREDIENT | RGL5YE86CZ | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| MAGNESIUM ALUMINUM SILICATE | INACTIVE INGREDIENT | 6M3P64V0NC | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| TITANIUM DIOXIDE | INACTIVE INGREDIENT | 15FIX9V2JP | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| XANTHAN GUM | INACTIVE INGREDIENT | TTV12P4NEE | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53045-201 | IONITE APF (SODIUM FLUORIDE) GEL [DHARMA RESEARCH, INC.] | 3 | Current NDC, Legacy NDC, 3 package rows | 20201117_8ff1b377-0535-4548-a109-f9f1a43b85b7.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 53045-201-08 | 53045020108 | 245 g in 1 BOTTLE (53045-201-08) | 245 g | 2013-01-01 | 0000-00-00 | No | No | Current |
| 53045-201-17 | 53045020117 | 490 g in 1 BOTTLE (53045-201-17) | 490 g | 2013-01-01 | 0000-00-00 | No | No | Current |
| 53045-201-38 | 53045020138 | 3724 g in 1 BOTTLE (53045-201-38) | 3724 g | 2013-01-01 | 0000-00-00 | No | No | Current |