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 |
|---|---|---|---|---|---|---|
| Listerine Essential Care | SODIUM MONOFLUOROPHOSPHATE | Kenvue Brands LLC | 90b5c3d8-baa4-44ab-8f73-e177007f0219 | 2025-10-10 | Warnings | M022 |
| DuoCare Clinical Oral Rinse | CETYLPYRIDINIUM CHLORIDE | Medline Industries, LP | 98e61cd5-7e29-7066-e053-2a95a90afa21 | 2025-10-10 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 40b756b7-ce1b-6482-e063-6294a90a0425 | 2025-10-09 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Gil Pharmaceutical Corp | 85053391-8d71-ab4f-e053-2991aa0a7e08 | 2025-10-09 | Warnings | M022 |
| Listerine Gum Therapy Mouthwash Glacier Mint | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Kenvue Brands LLC | 40a0bdf3-1698-1449-e063-6394a90ab13d | 2025-10-08 | Warnings | M022 |
| Kalaya Breath Refresh | MOUTHWASH | Avaria Health and Beauty Corp | 750e99ff-72e4-3c2f-e053-2a91aa0ad5a0 | 2025-10-08 | Warnings | M022 |
| Trader Joes | SODIUM FLUORIDE 0.24% AND POTASSIUM NITRATE 5% | TRADER JOE'S COMPANY | 159abeba-6da2-2643-e063-6394a90a730d | 2025-10-08 | Warnings | M022 |
| Family Wellness Oral Pain Relief | BENZOCAINE 20% | FAMILY DOLLAR SERVICES INC | 105d87d6-9147-43d4-e063-6394a90a57ee | 2025-10-08 | Warnings | M022 |
| Equate Glistening Mint | SODIUM FLUORIDE | Walmart Inc. | 39ff21ee-a362-014e-e063-6294a90a0d91 | 2025-10-03 | Warnings | M022 |
| Mouth Sore Relief Professional Strength | BENZOCAINE | CVS Pharmacy | 1b7209f6-8368-47fa-8df2-b049613b8c1b | 2025-09-30 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | Family Dollar (FAMILY WELLNESS) | 9db73da2-5b70-41e6-bcf9-caa7f1142024 | 2025-09-29 | Warnings | M022 |
| Esunix Oral Bacteriostatic Liquid | CETYLPYRIDINIUM CHLORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47d7e1-b6ae-efd1-e063-6394a90a4602 | 2025-09-27 | Warnings | M022 |
| Chloraseptic Sore Throat Cherry | PHENOL | Prestige Brands Holdings, Inc. | d5d62f7a-8f92-4d42-a2fb-691f896f72fc | 2025-09-26 | Warnings | M022 |
| Giltuss Bucalsep | BENZOCAINE, MENTHOL, ZINC CHLORIDE | Dextrum Laboratories Inc. | 3fa233dc-156c-1e95-e063-6294a90a8bbd | 2025-09-25 | Warnings | M022 |
| Finafta MultiOral | BENZOCAINE | Dextrum Laboratories Inc. | cb027ab8-4175-4cc0-a73e-991dfb113df9 | 2025-09-23 | Warnings | M022 |
| 4-in-1 Teeth Care Pens | 4-IN-1 TEETH CARE PENS | Jiangxi Dentalbright Technology Co., Ltd | 3f872924-0c44-267b-e063-6394a90a1a67 | 2025-09-23 | Warnings | M022 |
| Dental Relief | BENZOCAINE | Cintas Corporation | 0f40f775-797e-43cf-88c9-00eea666494f | 2025-09-23 | Warnings | M022 |
| Seavue Anti-caries Gel | SODIUM FLUORIDE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f4c6086-b96d-8fa4-e063-6294a90ad800 | 2025-09-21 | Warnings | M022 |
| Seavue Dental Desensitizer | POTASSIUM NITRATE AND SODIUM FLUORIDE DENTIFRICE | Xiling (Zhenjiang) Medical Technology Co., Ltd. | 3f47f399-1a14-5264-e063-6394a90aeb1c | 2025-09-20 | Warnings | M022 |
| Povi-One | POVIDONE-IODINE 10% TOPICAL | Elevate Oral Care | 27c29a33-d1cc-d72f-e063-6394a90a4d45 | 2025-09-19 | 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 |