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
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 |
|---|---|---|---|---|---|---|
| Hydrogen Peroxide 3 Percent ReadyInCase | HYDROGEN PEROXIDE | P & L Development, LLC | b0866db5-3b0d-4478-9b3b-1f077d2f5393 | 2026-08-06 | Warnings | M022 |
| Ollie Fresh Mint | SODIUM FLUORIDE, POTASSIUM NITRATE | Brio Product Group LLC. | ebeec44f-3c22-43f2-9256-6ece6025c105 | 2026-08-06 | Warnings | M022 |
| PRO-SYS | ORAL WOUND CLEANSER | Forward Science Technologies LLC | c357c8f8-6fd6-c2f8-e053-2995a90a4023 | 2026-07-30 | Warnings | M022 |
| Lornamead Natural White | FLUORIDE | Lornamead Products | 9d7d08d7-8ca4-4b05-8b74-3bfa372b1608 | 2026-07-29 | Warnings | M022 |
| Made by Dentists Enamel 10 Fluoride Anticavity | POTASSIUM NITRATE, SODIUM FLUORIDE | Made By Dentists Inc | 3c62eab1-0cb6-4bdf-bfd4-c5afe734d036 | 2026-07-24 | Warnings | M022 |
| Saline | NASAL | BEST CHOICE (VALU MERCHANDISERS COMPANY) | 71485e82-bf54-4b8b-8dd2-2a0761534520 | 2026-07-17 | Warnings | M022 |
| Good Neighbor Sore Throat Cherry Flavor | PHENOL | AMERISOURCE BERGEN | aa8fb8ff-61c7-41ba-9a23-1052e2b6cd7f | 2026-07-13 | Warnings | M022 |
| ABC Sore Throat Menthol Flavor | PHENOL | AMERISOURCE BERGEN | 9d9baf58-4790-4ff4-a462-5eb70c0e80c5 | 2026-07-13 | Warnings | M022 |
| Hydrogen Peroxide | HYDROGEN PEROXIDE | P & L Development, LLC | 350b5f64-d152-40cb-b22f-98541f0e1b0a | 2026-07-09 | Warnings | M022 |
| Quality Choice Natural White | FLUORIDE | CHAIN DRUG MARKETING ASSOCIATION INC | 561a75c2-a40c-ba7c-e063-6294a90aa119 | 2026-07-08 | Warnings | M022 |
| SALINE NASAL | SODIUM CHLORIDE | ALAINA HEALTHCARE PRIVATE LIMITED | ed30a7f9-7132-42da-9bed-63a9b1c80ab2 | 2026-07-07 | Warnings | M022 |
| Tumeez Organic Apple | CALCIUM CARBONATE | BFY LLC | f561685a-5260-59c6-e053-2a95a90ae206 | 2026-07-06 | Warnings | M022 |
| MUCINEX INSTASOOTHE SORE THROAT PLUS PAIN RELIEF | HEXYLRESORCINOL | Reckitt Benckiser LLC | 4c150222-06ea-4fcf-967f-84e19846bd66 | 2026-07-03 | Warnings | M022 |
| Dental system starter kit | US CONVENIENCE KIT (718907) | Dyson Technology Limited | 5355b79b-711f-1a4a-e063-6394a90afc4b | 2026-06-30 | Warnings | M022 |
| Anticavity and sensitive peppermint | 907 US VARIANT ANTICAVITY AND SENSITIVE TOOTHPASTE NON FOAMING PEPPERMINT | Dyson Technology Limited | 5332ab71-d994-39cf-e063-6294a90a0d98 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55820ff9-7b4b-2bce-e063-6394a90a8b43 | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 55806cb8-cf92-c4e5-e063-6394a90aaa2d | 2026-06-30 | Warnings | M022 |
| NebuClear MD Saline | NEBUCLEAR MD SALINE | Blue Echo Care LLC | 5581d8e5-4105-e9da-e063-6394a90a316e | 2026-06-30 | Warnings | M022 |
| Corinz | CETYLPYRIDINIUM CHLORIDE | Sage Products, LLC | 685b6023-89c4-417e-af2d-52e831855da1 | 2026-06-29 | Warnings | M022 |
| Antiplaque solution | CETYLPYRIDINIUM CHLORIDE | Sage Products LLC | 881d4d08-4b45-486a-93af-18c0e00a5b0e | 2026-06-29 | 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 |