BIO SPECTRA
- Product NDC
- 61649-733
- 11-digit product format
- 616490733
- Labeler code
- 61649
- Product ID
- 61649-733_124a286a-fd2a-6d1d-e063-6294a90a6c18
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Sodium fluoride and Potassium nitrate
- Dosage form
- PASTE, DENTIFRICE
- Route
- DENTAL
- Labeler
- 9055-7588 Quebec Inc. DBA Attitude
- Application
- M022
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-04-26
- Substance
- POTASSIUM NITRATE; SODIUM FLUORIDE
- Active strength
- 5; .243 g/100g; g/100g
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BIO SPECTRA
- Brand name suffix
- ATTITUDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| POTASSIUM NITRATE | 5 g/100g |
| SODIUM FLUORIDE | .243 g/100g |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | RU45X2JN0Z, 8ZYQ1474W7 |
| Rxcui | 1038800 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 61649-733-01 | BIO SPECTRAATTITUDE | 120 g in 1 TUBE | PASTE, DENTIFRICE | 120 | | 5 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 61649-733 | BIO SPECTRA ATTITUDE (SODIUM FLUORIDE AND POTASSIUM NITRATE) PASTE, DENTIFRICE [9055-7588 QUEBEC INC. DBA ATTITUDE] | 5 | Current NDC, Legacy NDC, 1 package rows | 20240426_42b79ec5-f37f-4dc9-9631-c8b1c153fe88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 61649-733-01 | 61649073301 | 120 g in 1 TUBE (61649-733-01) | 120 g | 2024-04-26 | 0000-00-00 | No | No | Current |