BURBLE
- Product NDC
- 83557-001
- 11-digit product format
- 835570001
- Labeler code
- 83557
- Product ID
- 83557-001_46f3fd57-d2fa-5999-e063-6294a90a6bee
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- SODIUM CHLORIDE
- Dosage form
- TABLET, FOR SOLUTION
- Route
- NASAL
- Labeler
- LETS BURBLE, INC.
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2024-05-08
- Substance
- CALCIUM BICARBONATE; SODIUM CHLORIDE
- Active strength
- 65; 2860 mg/1; mg/1
- Pharmacologic classes
- Alkalinizing Activity [MoA]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BURBLE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CALCIUM BICARBONATE | 65 mg/1 |
| SODIUM CHLORIDE | 2860 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 7PRA4BLM2L, 451W47IQ8X |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 83557-001-30 | BURBLE | 30 in 1 BAG | TABLET, FOR SOLUTION | 30 | | 3 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 83557-001 | BURBLE (SODIUM CHLORIDE) TABLET, FOR SOLUTION [LETS BURBLE, INC.] | 2 | Current NDC, 1 package rows | 20241213_17f48d4f-907c-3829-e063-6394a90ab202.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Sample | Exclude flag | Status |
|---|
| 83557-001-30 | 83557000130 | 30 TABLET, FOR SOLUTION in 1 BAG (83557-001-30) | 2024-05-08 | No | No | Historical |