CTx3 Rinse
- Product NDC
- 61578-301
- 11-digit product format
- 615780301
- Labeler code
- 61578
- Product ID
- 61578-301_df3e49c7-6a95-b6db-e053-2995a90a00b8
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Anticaries
- Dosage form
- RINSE
- Route
- DENTAL
- Labeler
- Dental Alliance Holdings LLC
- Application
- part355
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2012-05-01
- Marketing end
- 0000-00-00
- Substance
- SODIUM FLUORIDE
- Active strength
- 226 ug/mL
- NDC exclude flag
- No
- Listing certified through
- 2023-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| fb7ab793-2c12-4079-b100-a64f73bef25a | Product name | 4 | 20240712 |
| b0cbf770-6cc3-4aa4-9158-755110c2b9f7 | Product name | 2 | 20230717 |
| dc7c5daa-021f-40dd-b00d-63982cb2067a | Product name | 1 | 20230426 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 5 | 20200925 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 7cda52fc-125f-421c-8fea-bc1974370c49 | Product name | 2 | 20180703 |
| 419aab54-5d5a-4146-9453-026d4a9991be | Product name | 2 | 20170525 |
| 08ffbcbf-26df-b99c-1dab-64fc4cfae89f | Product name | 2 | 20160823 |
| 89dac932-b90a-4410-9ab1-84c53e57de25 | Product name | 1 | 20150316 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 61578-301-01 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-4da3-60a7-e053-dbdaa90a05bd | Maintenance Rinse |
| 61578-301-02 | 2024-01-30 | C162847 | 48780-1 | 9855e2a2-4da3-60a7-e053-dbdaa90a05bd | Maintenance Rinse |
| 61578-301-01 | 2022-05-17 | C162847 | 48780-1 | 9855e2a2-4da3-60a7-e053-dbdaa90a05bd | Maintenance Rinse |
| 61578-301-02 | 2022-05-17 | C162847 | 48780-1 | 9855e2a2-4da3-60a7-e053-dbdaa90a05bd | Maintenance Rinse |
| 61578-301-01 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4da3-60a7-e053-dbdaa90a05bd | Maintenance Rinse |
| 61578-301-02 | 2019-11-27 | C162847 | 48780-1 | 9855e2a2-4da3-60a7-e053-dbdaa90a05bd | Maintenance Rinse |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61578-301-01 | CTx3 RinseMint | 473 mL in 1 BOTTLE, PLASTIC | RINSE | 473 | 3 | |
| 61578-301-02 | CTx3 RinseMint | 59 mL in 1 BOTTLE, PLASTIC | RINSE | 59 | 3 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 61578-301 | CTX3 RINSE MINT (ANTICARIES) RINSE CTX3 RINSE GRAPE (ANTICARIES) RINSE CTX3 RINSE CITRUS (ANTICARIES) RINSE [DENTAL ALLIANCE HOLDINGS LLC] | 3 | Legacy NDC, 2 package rows | 20230102_aa61834a-ff12-4c31-828f-43b1292fef3d.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1486534 | CTx3 0.05 % Oral Rinse | PSN | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | PSN | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 1486534 | sodium fluoride 0.5 MG/ML Mouthwash [CTx3 Rinse] | SBD | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 240698 | sodium fluoride 0.5 MG/ML Mouthwash | SCD | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 1486534 | CTx3 Rinse (fluoride ion 0.226 MG/ML ) Mouthwash | SY | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 1486534 | CTx3 Rinse 0.05 % Mouthwash | SY | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 1486534 | CTx3 Rinse 0.5 MG/ML Mouthwash | SY | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
| 240698 | sodium fluoride 0.05 % (fluoride ion 0.02 % ) Oral Rinse | SY | aa61834a-ff12-4c31-828f-43b1292fef3d | 3 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 61578-301-01 | 61578030101 | 473 mL in 1 BOTTLE, PLASTIC (61578-301-01) | 473 ml | 2012-05-01 | 0000-00-00 | No | No | Current |
| 61578-301-02 | 61578030102 | 59 mL in 1 BOTTLE, PLASTIC (61578-301-02) | 59 ml | 2012-05-01 | 0000-00-00 | No | No | Current |