Whitening
- Product NDC
- 11673-385
- 11-digit product format
- 116730385
- Labeler code
- 11673
- Product ID
- 11673-385_441eb113-64d9-ceeb-e063-6394a90a2f74
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Monofluorophosphate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- Target
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-02-10
- Substance
- SODIUM MONOFLUOROPHOSPHATE
- Active strength
- .14 g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
NDC auxiliary status#
These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.
| Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Source date |
|---|---|---|---|---|---|---|---|
| excluded package | package | 11673-385 | 11673-385-08 | D | Discontinued by firm | 2026-10-12 |
Observed NDC auxiliary status history#
This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
| Captured / source date | Dataset | Scope | Product NDC | Package NDC | Code | Status | Reporting period | Archive | Snapshot | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|---|
| 2025-12-14 17:58 UTC · source 2025-12-05 | excluded package | package | 11673-385 | 11673-385-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | d630ba8d3edf… | 732f749b63fb… | |
| 2025-08-27 00:01 UTC · source 2025-08-26 | excluded package | package | 11673-385 | 11673-385-08 | D | Discontinued by firm | excluded / ndc_excluded.zip | f5e01cc5f278… | a2eaf40c39c3… |
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
- Whitening
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM MONOFLUOROPHOSPHATE | .14 g/100g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| C810JCZ56Q | Internal UNII lookup |
Harmonized RxCUI identifiers#
| Identifier | FDA.report destination |
|---|---|
| 545626 | Internal RxNorm lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 0074630f-9d8d-9209-e063-6294a90a4f01 | Available on FDA.report |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 3c386306-c48a-413e-bb69-70cb268496f3 | Product name | 1 | 20210727 |
| 6084a4f4-5437-c9a5-caec-5361ee075a59 | Product name | 1 | 20140508 |
| 90c5639a-61b0-88d6-ddcf-21888e94869a | Product name | 1 | 20140508 |
| 9514609b-a2a9-f8ec-6ba6-3f8e5ee89877 | Product name | 1 | 20140508 |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11673-385-08 | Whitening | 1 in 1 CARTON | PASTE, DENTIFRICE | 1 | 6 | |
| 11673-385-08 | Whitening | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 6 | |
| 11673-385-09 | Whitening | 2 in 1 CARTON | PASTE, DENTIFRICE | 2 | 6 | |
| 11673-385-09 | Whitening | 113 g in 1 TUBE | PASTE, DENTIFRICE | 113 | 6 |
DailyMed Dashboard NDC Coverage#
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 |
|---|---|---|---|---|---|---|
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | 64f3d92d-f58c-4bc2-8819-f91492221ddb | 2026-03-02 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Old East Main Co. | c7b9e9cd-3cf7-4657-83c9-e221e1c35977 | 2026-03-02 | Warnings, Adverse reactions | M021 |
| Instant Whitening | INSTANT WHITENING TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 2807ece8-a1a5-b626-e063-6394a90aac62 | 2026-03-02 | Warnings | M021 |
| Coffe Tea Stain Remover Tooth | COFFE TEA STAIN REMOVER TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 2845d7af-7a0b-9bc8-e063-6294a90ac8b3 | 2026-03-02 | Warnings | M021 |
| Professional whitening tooth | PROFESSIONAL WHITENING TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 291eba71-14da-fac3-e063-6294a90aa3cc | 2026-03-02 | Warnings | M021 |
| purple tooth | PURPLE TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 291f0312-238c-71d5-e063-6294a90a39e1 | 2026-03-02 | Warnings | M021 |
| Professional Choice | PROFESSIONAL CHOICE TOOTHPASTE | Guangzhou City Caiye Cosmetics CO., Ltd | 28406739-6a8c-1ce8-e063-6394a90a08f8 | 2026-03-02 | Warnings | M021 |
| Anticavity | SODIUM FLUORIDE | The Kroger Co. | 27a98b64-8369-4f3d-b487-d7ce98abc69f | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | The Kroger Co. | 390dd1b5-2dd1-4b55-b4b3-e441ada61238 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | The Kroger Co. | 5459eeee-adf0-4afe-b190-62d4fa113806 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Oral Antivavity | SODIUM FLUORIDE | The Kroger Co. | 932723b8-9875-4f37-8c11-018c94ae0ae1 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | The Kroger Co. | d0c552d8-44ad-4d95-b3fb-17015f44b334 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Walmart Inc. | 3beb65e4-ae8e-4e51-b9ba-181cbec41eff | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | 61669087-0af6-4192-b514-afcfe7d8ba98 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | e79e43e6-d6b6-4df4-9d9f-fe9fe35f180d | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Alcohol-Free Anticavity | SODIUM FLUORIDE | Walmart Inc. | 1fd2f3ca-066e-282a-e063-6294a90a05a9 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | af5b93e7-5cce-4e01-8df2-54494d8b2910 | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Anticavity | SODIUM FLUORIDE | Walmart Inc. | 4590ca97-130c-46b2-9ba0-38f4703ef30a | 2026-02-27 | Warnings, Adverse reactions | M021 |
| Colgate Anticavity | SODIUM MONOFLUOROPHOSPHATE | MING FAI ENTERPRISE (CAMBODIA) CO., LTD. | 4ba81636-cdb7-e904-e063-6394a90a8bd5 | 2026-02-25 | Warnings | M021 |
| Anticavity Rinse | SODIUM FLUORIDE | Family Dollar Stores, Inc | 32a92add-c9db-4733-8e35-613825fdf081 | 2026-02-24 | Warnings, Adverse reactions | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 545626 | sodium monofluorophosphate 0.76 % Toothpaste | PSN | 0074630f-9d8d-9209-e063-6294a90a4f01 | 6 |
| 545626 | sodium monofluorophosphate 0.0076 MG/MG Toothpaste | SCD | 0074630f-9d8d-9209-e063-6294a90a4f01 | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.12 % )Toothpaste | SY | 0074630f-9d8d-9209-e063-6294a90a4f01 | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.13 % )Toothpaste | SY | 0074630f-9d8d-9209-e063-6294a90a4f01 | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.14 % )Toothpaste | SY | 0074630f-9d8d-9209-e063-6294a90a4f01 | 6 |
| 545626 | sodium monofluorophosphate 0.76 % (fluoride ion 0.15 % )Toothpaste | SY | 0074630f-9d8d-9209-e063-6294a90a4f01 | 6 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 11673-385-08 | 11673038508 | 1 in 1 CARTON | Historical | ||||
| 11673-385-09 | 11673038509 | 2 TUBE in 1 CARTON (11673-385-09) / 113 g in 1 TUBE | 2 tube | 2025-01-24 | No | No | Current |