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 |
|---|---|---|---|---|---|---|
| Sensitivity Relief Fluoride Free | POTASSIUM NITRATE | Health and Natural Beauty USA Corp | c23b2a83-ebc3-4bcf-a216-7693944dcfa0 | 2026-05-22 | Warnings | M022 |
| Sensitivity and Gum with Cavity Protection | POTASSIUM NITRATE AND SODIUM FLUORIDE | Health and Natural Beauty USA Corp | 137d6935-19a3-499d-957c-820156eec7a5 | 2026-05-22 | Warnings | M022 |
| SEXYTEETH MINTY T00THPASTE | SEXYTEETH MINTY TOOTHPASTE | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 51d288c1-fe86-ffe1-e063-6394a90ab4c4 | 2026-05-14 | Warnings | M022 |
| Cepacol Extra Strength Sore Throat cherry | BENZOCAINE AND MENTHOL | Reckitt Benckiser LLC | 941e36dd-d8d0-4e5c-8585-10e8f06bf8f0 | 2026-05-12 | Warnings | M022 |
| Cepacol Extra Strength Sore Throat honey lemon | BENZOCAINE AND MENTHOL | Reckitt Benckiser LLC | d771095b-7de3-48f3-a125-8bc76e7d1778 | 2026-05-12 | Warnings | M022 |
| SEXYTEETH CHARCOAL T00THPASTE | SEXYTEETH CHARCOAL TOOTHPASTE | WORLD DENTISTS ASSOCIATION AMERICA LIMITED | 51ab8a9a-6c12-b13b-e063-6294a90ace2a | 2026-05-12 | Warnings | M022 |
| 365 Whole Foods Market Spearmint Flavored Fluoride Mouthwash Anticavity | FLUORIDE | WHOLE FOODS | 25bc7ab1-116d-143a-e063-6394a90aa970 | 2026-05-04 | Warnings | M022 |
| Gingicaine Gel Strawberry | GINGICAINE GEL STRAWBERRY FLAVOR | Gingi-Pak a Division of the Belport | 2fd37612-a28b-3aa1-e054-00144ff8d46c | 2026-05-01 | Warnings | M022 |
| 3ECARE Dual formula WhiteningToothpaste Refill | SODIUM FLUORIDE | Hangzhou Namei Zhikang Technology Co., Ltd. | 501df1c7-4884-bb39-e063-6294a90aaf6a | 2026-04-23 | Warnings | M022 |
| Ora YoGu 4X Medicated Tooth and Gum Pain Reliever | MEDICATED TOOTH AND GUM PAIN RELIEVER | Kungpo Health Care & Herbal Center Inc | 1f10a72f-0b49-41cb-92f9-b0160d7664de | 2026-04-22 | Warnings | M022 |
| EverSmile AlignerFresh Enamel Guard | SODIUM FLUORIDE | Everbrands, Inc. | 7b3d0114-dac0-4370-8545-922ec018018e | 2026-04-21 | Warnings | M022 |
| PREOP | HYDROGEN PEROXIDE | Everbrands, Inc. | cc5cdd29-92c1-4ce0-997e-eb624b288b09 | 2026-04-20 | Warnings | M022 |
| 4x Medicated Toothache and Gum Cream | BENZOCAINE | CVS | a7576238-e7c8-7e86-e053-2995a90aaeb5 | 2026-04-20 | Warnings | M022 |
| CVS Pharmacy Maximum Strength | BENZOCAINE | CVS Pharmacy | 92747826-cf58-4406-b3b5-12f7c7077c2c | 2026-04-20 | Warnings | M022 |
| Antiseptic | EUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOL | Family Dollar (FAMILY WELLNESS) | 9f991292-bbaa-4f4e-b2cb-059d1a04849e | 2026-04-20 | Warnings | M022 |
| Osstem S Sensitivity relief tooth | POTASSIUM NITRATE, SODIUM FLUORIDE | Osstem Pharma Co., Ltd | 4f8ab179-8f29-a7cf-e063-6294a90a0c22 | 2026-04-15 | Warnings | M022 |
| Crest Pro-Health Gum DetoxifyWinter Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6db58f-0b09-d155-e063-6394a90ae658 | 2026-04-14 | Warnings | M022 |
| Lolleez Orange Mango | PECTIN | BFY LLC | 4f6dec8b-078a-f321-e063-6294a90a248c | 2026-04-14 | Warnings | M022 |
| Crest Pro-Health Gum Restore Smooth Mint | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6e3b36-e565-7d27-e063-6294a90ae5ac | 2026-04-14 | Warnings | M022 |
| Crest Pro-Health Nightly Bacteria Shield | CETYLPYRIDINIUM CHLORIDE | The Procter & Gamble Manufacturing Company | 4f6ec1e0-c6b5-226f-e063-6294a90a8f14 | 2026-04-14 | 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 |