AQUAFRESH
- Product NDC
- 0135-0591
- 11-digit product format
- 001350591
- Labeler code
- 0135
- Product ID
- 0135-0591_4af361ee-0754-8996-e063-6294a90aab2d
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- sodium fluoride
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2014-05-09
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.15 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AQUAFRESH
- Brand name suffix
- EXTRA FRESH PLUS WHITENING
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| SODIUM FLUORIDE | 1.15 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 8ZYQ1474W7 |
| Rxcui | 1044547 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0591-01 | AQUAFRESHEXTRA FRESH PLUS WHITENING | 1 in 1 CARTON | PASTE | 1 | | 9 |
| 0135-0591-01 | AQUAFRESHEXTRA FRESH PLUS WHITENING | 158.8 g in 1 TUBE | PASTE | 158.8 | | 9 |
| 0135-0591-02 | AQUAFRESHEXTRA FRESH PLUS WHITENING | 85.1 g in 1 TUBE | PASTE | 85.1 | | 9 |
| 0135-0591-02 | AQUAFRESHEXTRA FRESH PLUS WHITENING | 1 in 1 CARTON | PASTE | 1 | | 9 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0591 | AQUAFRESH CAVITY PROTECTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTRA FRESH PLUS WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH MULTI ACTION WHITENING (SODIUM FLUORIDE) PASTE AQUAFRESH ULTIMATE WHITE (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 8 | Current NDC, Legacy NDC, 4 package rows | 20240301_5484999c-8e6f-430d-99a5-6893a2489467.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 |
|---|
| 0135-0591-01 | 00135059101 | 1 TUBE in 1 CARTON (0135-0591-01) / 158.8 g in 1 TUBE | 1 tube | 2016-10-01 | 0000-00-00 | No | No | Current |
| 0135-0591-02 | 00135059102 | 1 TUBE in 1 CARTON (0135-0591-02) / 85.1 g in 1 TUBE | 1 tube | 2016-11-01 | 0000-00-00 | No | No | Current |