Opalescence Whitening
- Product NDC
- 51206-302
- 11-digit product format
- 512060302
- Labeler code
- 51206
- Product ID
- 51206-302_5b14d90f-23ec-372b-e063-6294a90a2066
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium Fluoride
- Dosage form
- GEL, DENTIFRICE
- Route
- DENTAL
- Labeler
- Ultradent Products, Inc
- Application
- M021
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 1994-07-01
- Marketing end
- 2030-09-30
- Substance
- SODIUM FLUORIDE
- Active strength
- 1.1 mg/g
- NDC exclude flag
- No
- 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
- Opalescence Whitening
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM FLUORIDE | 1.1 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 |
|---|---|
| d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | Available on FDA.report |
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 51206-302-06 | Opalescence Whitening | 133 g in 1 TUBE | GEL, DENTIFRICE | 133 | 9 | |
| 51206-302-06 | Opalescence Whitening | 1 in 1 BOX | GEL, DENTIFRICE | 1 | 9 | |
| 51206-302-07 | Opalescence Whitening | 1 in 1 BOX | GEL, DENTIFRICE | 1 | 9 | |
| 51206-302-07 | Opalescence Whitening | 28.35 g in 1 TUBE | GEL, DENTIFRICE | 28.35 | 9 | |
| 51206-302-08 | Opalescence Whitening | 1 in 1 BOX | GEL, DENTIFRICE | 1 | 9 | |
| 51206-302-08 | Opalescence Whitening | 3 in 1 PACKAGE, COMBINATION | GEL, DENTIFRICE | 3 | 9 | |
| 51206-302-09 | Opalescence Whitening | 1 in 1 BOX | GEL, DENTIFRICE | 1 | 9 | |
| 51206-302-09 | Opalescence Whitening | 12 in 1 PACKAGE, COMBINATION | GEL, DENTIFRICE | 12 | 9 | |
| 51206-302-10 | Opalescence Whitening | 24 in 1 PACKAGE, COMBINATION | GEL, DENTIFRICE | 24 | 9 | |
| 51206-302-10 | Opalescence Whitening | 1 in 1 BOX | GEL, DENTIFRICE | 1 | 9 | |
| 51206-302-11 | Opalescence Whitening | 1 in 1 BOX | GEL, DENTIFRICE | 1 | 9 | |
| 51206-302-11 | Opalescence Whitening | 6 in 1 PACKAGE, COMBINATION | GEL, DENTIFRICE | 6 | 9 |
DailyMed Socrata Ingredients#
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 |
|---|---|---|---|---|---|---|
| Murchison Hume Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Buzz Products Inc. | b1a442e1-86cf-cba6-e053-2995a90a593a | 2023-12-20 | Warnings | M021 |
| United Airlines Polaris Kit with Colgate | SODIUM MONOFLUOROPHOSPHATE | Buzz Export Services Pty Ltd (Buzz Products) | de4564a4-1012-baad-e053-2a95a90a11b7 | 2023-12-20 | Warnings | M021 |
| Orajel Complete Protection | SODIUM FLUORIDE | Church & Dwight Co., Inc. | daebd16f-d278-446d-8b7a-33add5a74fdd | 2023-12-19 | Warnings | M021 |
| Orajel Sensitivity Relief | SODIUM FLUORIDE AND POTASSIUM NITRATE | Church & Dwight Co., Inc. | 7b9d9e7d-3844-4d18-ab03-bd0e9dcfccdb | 2023-12-19 | Warnings | M021 |
| ORTHO GUARD | SODIUM FLUORIDE | Massco Dental A Division of Dunagin Pharmaceuticals | 8d3e0dd0-b584-413b-adf3-5c2d05ab72dd | 2023-12-17 | Warnings | M021 |
| Beyond Activated Coconut Charcoal and Sea Salt | SODIUM FLUORIDE | Beyond International Inc | d075fa15-7309-0c10-e053-2995a90a7c95 | 2023-11-28 | Warnings | M021 |
| Pro-Den Rx | STANNOUS FLUORIDE | Den-mat Holdings, Llc | 9036aa8a-59b1-41b0-b3cb-529d3303a1c0 | 2023-11-20 | Warnings | M021 |
| Fluoridex | STANNOUS FLUORIDE RINSE | DEN-MAT HOLDINGS, LLC | 5e81f073-c0ca-aa38-e053-2a91aa0ab37b | 2023-11-20 | Warnings | M021 |
| Hello Vitamin C Whitening | SODIUM FLUORIDE | Colgate-Palmolive Company | 38a0276e-910c-527d-1736-65928b9d4ca4 | 2023-11-20 | Warnings | M021 |
| POP Feeling Peachy | SODIUM FLUORIDE | LG H&H CO., LTD. | 0abaf99b-9547-46ae-e063-6394a90a6c15 | 2023-11-17 | Warnings | M021 |
| UNIVERSAL ANTI-CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | e3356374-befa-41b0-ab0f-edfd5a062601 | 2023-11-16 | Warnings | M021 |
| ANTI CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 421fc2f0-b118-4e7a-a399-ba4780028c54 | 2023-11-16 | Warnings | M021 |
| UNIVERSAL CHARCOAL WITH ALOE VERA ANTI-CAVITY FLUORIDE | SODIUM FLUORIDE | Universal Distribution Center LLC | 3411924d-1002-460c-83e8-c0c7fbff9ad1 | 2023-11-16 | Warnings | M021 |
| ADVANCED WHITENING ANTI CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 8ea8a8d9-b7e4-468f-9a09-4ec634cbd80e | 2023-11-16 | Warnings | M021 |
| UNIVERSAL ADVANCED WHITENING ANTI-CAVITY FLUORIDE | SODIUM MONOFLUOROPHOSPHATE | Universal Distribution Center LLC | 879dfaf0-27c8-41a3-8d01-a1c3eec9edfc | 2023-11-15 | Warnings | M021 |
| EUTHYMOL Extraordinary Pink Whitening | SODIUM FLUORIDE | LG H&H CO., LTD. | 0989936c-237d-dc63-e063-6294a90a885f | 2023-11-07 | Warnings | M021 |
| Eurofresh Whitening | SODIUM FLUORIDE | Farmasi US LLC | b56b2b55-e3a4-785a-e053-2a95a90a7abf | 2023-11-05 | Warnings | M021 |
| Farmasi Whitening | SODIUM FLUORIDE | Farmasi US LLC | 25b3608e-abed-41ca-9971-21981b8a4610 | 2023-11-05 | Warnings | M021 |
| United Airlines Therabody UPP Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | fb6c355b-a67d-c4b4-e053-6394a90a0e66 | 2023-10-26 | Warnings | M021 |
| United Dental Kit | SODIUM MONOFLUOROPHOSPHATE | Wessco International | 7f348fe7-9918-4934-bed0-f0a77c09d046 | 2023-10-26 | Warnings | M021 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1044547 | sodium fluoride 0.25 % Toothpaste | PSN | d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | 9 |
| 1044547 | sodium fluoride 0.0025 MG/MG Toothpaste | SCD | d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | 9 |
| 1044547 | sodium fluoride 0.25 % (fluoride ion 0.15 % ) Toothpaste | SY | d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | 9 |
| 1044547 | sodium fluoride 0.25 % Toothpaste | SY | d07f842e-b6f1-4ae1-b576-f542ecd02dd4 | 9 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 51206-302-06 | 51206030206 | 1 TUBE in 1 BOX (51206-302-06) / 133 g in 1 TUBE | 1 tube | 1994-07-01 | 2030-09-30 | No | No | Current |
| 51206-302-07 | 51206030207 | 1 TUBE in 1 BOX (51206-302-07) / 28.35 g in 1 TUBE | 1 tube | 1994-07-01 | 2030-09-30 | No | No | Current |
| 51206-302-08 | 51206030208 | 3 BOX in 1 PACKAGE, COMBINATION (51206-302-08) / 1 TUBE in 1 BOX / 133 g in 1 TUBE | 3 box | 2016-06-01 | 2030-09-30 | No | No | Current |
| 51206-302-09 | 51206030209 | 12 BOX in 1 PACKAGE, COMBINATION (51206-302-09) / 1 TUBE in 1 BOX / 133 g in 1 TUBE | 12 box | 2016-06-01 | 2030-09-30 | No | No | Current |
| 51206-302-10 | 51206030210 | 24 BOX in 1 PACKAGE, COMBINATION (51206-302-10) / 1 TUBE in 1 BOX / 28.35 g in 1 TUBE | 24 box | 2016-06-01 | 2030-09-03 | No | No | Current |
| 51206-302-11 | 51206030211 | 6 BOX in 1 PACKAGE, COMBINATION (51206-302-11) / 1 TUBE in 1 BOX / 133 g in 1 TUBE | 6 box | 2020-08-24 | 2030-09-30 | No | No | Current |