Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
- Product NDC
- 0126-0034
- 11-digit product format
- 001260034
- Labeler code
- 0126
- Product ID
- 0126-0034_0c0515c6-25cb-46b6-ada6-79f8aeb97a28
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM FLUORIDE
- Dosage form
- RINSE
- Route
- DENTAL
- Labeler
- Colgate Oral Pharmaceuticals, Inc.
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2011-02-15
- Substance
- SODIUM FLUORIDE
- Active strength
- 2 mg/10mL
- 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
- Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride
- Listing expiration
- 2027-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 2 mg/10mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 8ZYQ1474W7 | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 9a976ac8-d966-4d94-93da-45652f2d2481 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 726062af-1135-4707-a1d7-57256991bbf9 | Product name | 2 | 20250226 |
| 19c71a3d-ed9c-166b-a7e5-38c250c35631 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0126-0034-46 | Colgate Phos-Flur Ortho Defense Alcohol Free Anticavity Gushing Grape Fluoride | 500 mL in 1 BOTTLE | RINSE | 500 | 8 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0126-0034 | COLGATE PHOS-FLUR ORTHO DEFENSE ALCOHOL FREE ANTICAVITY GUSHING GRAPE FLUORIDE (SODIUM FLUORIDE) RINSE [COLGATE ORAL PHARMACEUTICALS, INC.] | 8 | Current NDC, Legacy NDC, 1 package rows | 20240113_9a976ac8-d966-4d94-93da-45652f2d2481.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 |
|---|---|---|---|---|---|---|
| Crest Complete plus Whitening plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | c5d5bc17-e81b-34aa-e053-2a95a90ad77f | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Gum Restore Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c5745cc4-213d-1dde-e053-2995a90af562 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Shield | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 960fef18-4533-5250-e053-2995a90aaf76 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Gum Restore Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c574b51d-07bd-b363-e053-2995a90a7c0e | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Blast | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 6d9a1754-8d38-054f-e053-2991aa0a4653 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Breath Purify and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c60fdacf-d997-19a5-e053-2a95a90a96a3 | 2026-01-08 | Warnings | M021 |
| Crest Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 3d7fffb9-47e0-73cd-e054-00144ff88e88 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Gum Detoxify Ultra | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c73ed36a-0e2f-a137-e053-2a95a90a43e0 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Advanced Extra Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c688d37e-9e80-4599-e053-2a95a90a1916 | 2026-01-08 | Warnings | M021 |
| Crest Gum Detoxify plus Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | 63779942-0f6c-11c5-e053-2991aa0a25ab | 2026-01-08 | Warnings | M021 |
| Crest Premium Plus Sensitivity Active Foam | SODIUM FLUORIDE AND POTASSIUM NITRATE | The Procter & Gamble Manufacturing Company | b8535d1c-cf15-f353-e053-2a95a90a7974 | 2026-01-08 | Warnings | M021 |
| Burts Bees Extra White Zen Peppermint | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 81279e1f-6224-8114-e053-2991aa0aab08 | 2026-01-08 | Warnings | M021 |
| Crest Pro-Health Bacteria Shield and Gum Deep Clean | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | c74229c4-b095-df32-e053-2a95a90a4aec | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Advanced Whitening Fresh Mint | SODIUM MONOFLUOROPHOSPHATE | The Procter & Gamble Manufacturing Company | c8350ab3-9347-58c0-e053-2995a90a7238 | 2026-01-08 | M021 | |
| Crest Premium Plus Anti-Bacterial | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | b7af946e-1cac-b8c0-e053-2a95a90afa4a | 2026-01-08 | Warnings | M021 |
| Crest 3D White Stain Eraser Polishing Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ddcb0871-9900-125f-e053-2a95a90a75de | 2026-01-08 | M021 | |
| Burts Bees Deep Clean plus Whitening | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | c924b8dd-8d84-1329-e053-2995a90a4531 | 2026-01-08 | Warnings | M021 |
| Crest Plus Baking Soda and Peroxide Whitening with Tartar Protection | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 07ed767e-225c-e9c5-e063-6394a90af931 | 2026-01-08 | Warnings | M021 |
| Crest Plus Cavity Protection Cool Mint Gel | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 0813171e-bda5-b004-e063-6394a90ad364 | 2026-01-08 | Warnings | M021 |
| Burts Bees Kids Strawberry Splash | SODIUM FLUORIDE | Procter & Gamble Manufacturing Company | 087b3434-2636-74ce-e063-6394a90a25ad | 2026-01-08 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1721964 | Colgate 0.02 % (0.01 % fluoride ion) Oral Rinse | PSN | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse | PSN | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 1721964 | sodium fluoride 0.2 MG/ML Mouthwash [Colgate] | SBD | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 313029 | sodium fluoride 0.2 MG/ML Mouthwash | SCD | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 1721964 | Colgate 0.02 % (0.01 % fluoride ion) Oral Rinse | SY | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 1721964 | Colgate 0.2 MG/ML Mouthwash | SY | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse | SY | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse | SY | 9a976ac8-d966-4d94-93da-45652f2d2481 | 8 |
| 1721964 | Colgate 0.02 % (0.01 % fluoride ion) Oral Rinse | PSN | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse | PSN | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 1721964 | sodium fluoride 0.2 MG/ML Mouthwash [Colgate] | SBD | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 313029 | sodium fluoride 0.2 MG/ML Mouthwash | SCD | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 1721964 | Colgate 0.02 % (0.01 % fluoride ion) Oral Rinse | SY | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 1721964 | Colgate 0.2 MG/ML Mouthwash | SY | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.009 % ) Oral Rinse | SY | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
| 313029 | sodium fluoride 0.02 % (fluoride ion 0.01 % ) Oral Rinse | SY | 83aaa7f8-cf61-1faa-e053-2a91aa0a98cd | 2 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0126-0034-46 | 00126003446 | 500 mL in 1 BOTTLE (0126-0034-46) | 500 ml | 2011-02-15 | 0000-00-00 | No | No | Current |