Gelato Neutral PH
- Product NDC
- 68400-138
- 11-digit product format
- 684000138
- Labeler code
- 68400
- Product ID
- 68400-138_202c46b4-9136-4bce-8cee-82718ebb3818
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- AEROSOL, FOAM
- Route
- DENTAL; ORAL; TOPICAL
- Labeler
- Deepak Products, inc.
- Marketing category
- UNAPPROVED DRUG OTHER
- Marketing start
- 2011-08-11
- Marketing end
- 0000-00-00
- Substance
- SODIUM FLUORIDE
- Active strength
- 3 g/125g
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
NDC auxiliary status#
Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|
| excluded product | product | 68400-138 | | I | Inactivated by FDA | | 2026-07-31 |
| excluded package | package | 68400-138 | 68400-138-04 | I | Inactivated by FDA | | 2026-07-31 |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 68400-138-04 | Gelato Neutral PH | 125 g in 1 BOTTLE, SPRAY | AEROSOL, FOAM | 125 | | 3 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| SODIUM FLUORIDE | ACTIVE INGREDIENT | 8ZYQ1474W7 | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| FLUORIDE ION | ACTIVE MOIETY | Q80VPU408O | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| DECYL GLUCOSIDE | INACTIVE INGREDIENT | Z17H97EA6Y | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| DMDM HYDANTOIN | INACTIVE INGREDIENT | BYR0546TOW | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| HYDROFLUORIC ACID | INACTIVE INGREDIENT | RGL5YE86CZ | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| PHOSPHORIC ACID | INACTIVE INGREDIENT | E4GA8884NN | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| POLOXAMER 407 | INACTIVE INGREDIENT | TUF2IVW3M2 | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| POTASSIUM HYDROXIDE | INACTIVE INGREDIENT | WZH3C48M4T | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| SACCHARIN SODIUM | INACTIVE INGREDIENT | SB8ZUX40TY | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| SODIUM LAURETH SULFATE | INACTIVE INGREDIENT | BPV390UAP0 | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| TROLAMINE | INACTIVE INGREDIENT | 9O3K93S3TK | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
| XYLITOL | INACTIVE INGREDIENT | VCQ006KQ1E | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 68400-138 | GELATO NEUTRAL PH (SODIUM FLUORIDE) AEROSOL, FOAM [DEEPAK PRODUCTS, INC.] | 3 | Legacy NDC, 1 package rows | 20110819_ba5c415e-2a44-4b49-b85a-55984e3131b8.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 68400-138-04 | 68400013804 | 125 g in 1 BOTTLE, SPRAY | 125 g | Historical |