AQUAFRESH
- Product NDC
- 0135-0234
- 11-digit product format
- 001350234
- Labeler code
- 0135
- Product ID
- 0135-0234_4af3766f-39a7-abd8-e063-6294a90ad4a7
- 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
- 2011-03-25
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.13 mg/g
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- AQUAFRESH
- Brand name suffix
- EXTREME CLEAN WHITENING ACTION
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 1.13 mg/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 1044547 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| aaff19d9-4ba5-462a-893b-7220feb25d6c | Available on FDA.report |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0135-0234-06 | AQUAFRESHEXTREME CLEAN WHITENING ACTION | 1 in 1 CARTON | PASTE | 1 | 23 | |
| 0135-0234-06 | AQUAFRESHEXTREME CLEAN WHITENING ACTION | 158.7 g in 1 TUBE | PASTE | 158.7 | 23 | |
| 0135-0234-08 | AQUAFRESHEXTREME CLEAN WHITENING ACTION | 158.7 g in 1 TUBE | PASTE | 158.7 | 23 | |
| 0135-0234-08 | AQUAFRESHEXTREME CLEAN WHITENING ACTION | 2 in 1 CARTON | PASTE | 2 | 23 | |
| 0135-0234-09 | AQUAFRESHEXTREME CLEAN WHITENING ACTION | 3 in 1 CARTON | PASTE | 3 | 23 | |
| 0135-0234-09 | AQUAFRESHEXTREME CLEAN WHITENING ACTION | 158.8 g in 1 TUBE | PASTE | 158.8 | 23 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0135-0234-08 | GM - Gram | 0135-0234 | 5ade2443-0c83-4e6d-a38d-f62e76c321d5 | 1 | 2017-03-06 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0135-0234 | AQUAFRESH EXTREME CLEAN WHITENING ACTION (SODIUM FLUORIDE) PASTE AQUAFRESH EXTREME CLEAN DEEP ACTION (SODIUM FLUORIDE) PASTE [HALEON US HOLDINGS LLC] | 22 | Current NDC, Legacy NDC, 6 package rows | 20240125_aaff19d9-4ba5-462a-893b-7220feb25d6c.zip |
openFDA label cross-check#
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Iolite | BENZOCAINE | Dharma Research, Inc. | e4b2d22b-00b3-45a6-9b7d-8ee719587059 | 2023-10-09 | Warnings | M022 |
| Iolite | BENZOCAINE | Dharma Research, Inc. | a0e284f6-292f-4231-8596-f7cee4e0a12f | 2023-10-09 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | fe92637a-c88a-f9dd-e053-6294a90a7fa3 | 2023-07-01 | Warnings | M022 |
| HurriCaine Topical Anesthetic | BENZOCAINE | Beutlich Pharmaceuticals, LLC | c979e958-2042-471a-bf03-e84e68620106 | 2023-06-20 | Warnings | M022 |
| Orajel Gum Pain 3X Medicated | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Church & Dwight Co., Inc. | 9a1632ad-2b47-5653-e053-2995a90ae0d9 | 2023-01-20 | Warnings | M022 |
| KOLORZ TOPICAL ANESTHETIC TRIPLE MINT | BENZOCAINE | DMG AMERICA, LLC | 0f90b227-f938-4e1a-a79e-1967b1a0477e | 2021-10-01 | Warnings | M022 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1044547 | sodium fluoride 0.25 % Toothpaste | PSN | aaff19d9-4ba5-462a-893b-7220feb25d6c | 23 |
| 1044547 | sodium fluoride 0.0025 MG/MG Toothpaste | SCD | aaff19d9-4ba5-462a-893b-7220feb25d6c | 23 |
| 1044547 | sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste | SY | aaff19d9-4ba5-462a-893b-7220feb25d6c | 23 |
| 1044547 | sodium fluoride 0.25 % Toothpaste | SY | aaff19d9-4ba5-462a-893b-7220feb25d6c | 23 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0135-0234-06 | 00135023406 | 1 TUBE in 1 CARTON (0135-0234-06) / 158.7 g in 1 TUBE | 1 tube | 2011-03-25 | 0000-00-00 | No | No | Current |
| 0135-0234-08 | 00135023408 | 2 TUBE in 1 CARTON (0135-0234-08) / 158.7 g in 1 TUBE | 2 tube | 2011-03-25 | 0000-00-00 | No | No | Current |
| 0135-0234-09 | 00135023409 | 3 TUBE in 1 CARTON (0135-0234-09) / 158.8 g in 1 TUBE | 3 tube | 2021-02-28 | No | No | Current |