AQUAFRESH
- Product NDC
- 0135-0605
- 11-digit product format
- 001350605
- Labeler code
- 0135
- Product ID
- 0135-0605_0e988328-62da-43e7-98b3-5d94a4cd6684
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- potassium nitrate and sodium fluoride
- Dosage form
- PASTE
- Route
- DENTAL
- Labeler
- Haleon US Holdings LLC
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2017-02-17
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 50; 1.1 mg/g; mg/g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AQUAFRESH
- Brand name suffix
- SENSITIVE MAXIMUM STRENGTH
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM NITRATE | 50 mg/g |
| SODIUM FLUORIDE | 1.1 mg/g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RU45X2JN0Z, 8ZYQ1474W7 |
| Rxcui | 1038929 |
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0135-0605-01 | AQUAFRESHSENSITIVE MAXIMUM STRENGTH | 158.8 g in 1 TUBE | PASTE | 158.8 | | 13 |
| 0135-0605-01 | AQUAFRESHSENSITIVE MAXIMUM STRENGTH | 1 in 1 CARTON | PASTE | 1 | | 13 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0135-0605 | AQUAFRESH SENSITIVE MAXIMUM STRENGTH (POTASSIUM NITRATE AND SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 13 | Current NDC, Legacy NDC, 2 package rows | 20240307_76adbccb-0812-4407-a6fc-a57e6f144fbb.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 |
|---|
| 0135-0605-01 | 00135060501 | 1 TUBE in 1 CARTON (0135-0605-01) / 158.8 g in 1 TUBE | 1 tube | 2017-02-17 | 0000-00-00 | No | No | Current |