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 | 2026-10-15 |
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 |
|---|---|---|---|---|---|---|
| Crest Pro Health Sensitive and Enamel Shield | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb48b15c-f821-e5cd-e053-6294a90ac64c | 2026-01-08 | Warnings | M021 |
| Crest 3D White Brilliance Luminous Purple | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | fbfcd837-4d88-5f82-e053-6394a90afbf6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health with a Touch of Scope | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb572b41-36cd-55d7-e053-6394a90a71c8 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Whitening Gel | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | fb5b1e94-bed6-8486-e053-6294a90a3a84 | 2026-01-08 | Warnings | M021 |
| Crest 3D White Ultra Vivid Mint | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | cba96ef0-0519-059f-e053-2a95a90a43ad | 2026-01-08 | Warnings | M021 |
| Crest 4in1 | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | ce545406-3c4f-1ba7-e053-2a95a90a91ac | 2026-01-08 | Warnings | M021 |
| Crest 3D White Advanced Whitening | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d218ddc0-1d5f-f39b-e053-2995a90a96ed | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Antibacterial Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d58bc842-2687-e52d-e053-2995a90a5433 | 2026-01-08 | Warnings | M021 |
| Scope Stay Strong | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | d65b3153-2026-a8c0-e053-2a95a90a31d6 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Charcoal | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6f68485-b92f-41c7-e053-2995a90a4fe5 | 2026-01-08 | Warnings | M021 |
| KIDS Crest Advanced Enamel Plus Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d837ecde-249a-7868-e053-2a95a90a56ae | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Whitening Intensive Cleaning | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d6fa4187-a651-647b-e053-2995a90a8567 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Gum Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7729dde-c828-34e6-e053-2a95a90a5ee6 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Whitening | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d811306f-4994-7a5a-e053-2995a90adf16 | 2026-01-08 | Warnings | M021 |
| Crest Densify Daily Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d810d4e5-ba66-efe1-e053-2995a90abfc0 | 2026-01-08 | Warnings | M021 |
| Crest Braces Care Cavity Protection | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d823cba4-c4cf-7d7a-e053-2995a90a01f0 | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Sensitive Relief | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d7730674-7513-52cf-e053-2995a90ab32c | 2026-01-08 | Warnings | M021 |
| Kids Crest Bubblegum Flavor | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 26a7a892-5da4-4749-bbb6-566efab7d749 | 2026-01-08 | Warnings | M021 |
| Crest Complete Multi-Benefit Plus Scope | SODIUM FLUORIDE | The Procter & Gamble Manufacturing Company | 8c91095d-88c0-4d22-a79a-7d0f0d05302b | 2026-01-08 | Warnings | M021 |
| Crest Pro Health Advanced Deep Clean Mint | STANNOUS FLUORIDE | The Procter & Gamble Manufacturing Company | d774295f-8ebd-9877-e053-2a95a90a9a0e | 2026-01-08 | Warnings | 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 |