BRONCO SILEN-DM
- Product NDC
- 59561-202
- 11-digit product format
- 595610202
- Labeler code
- 59561
- Product ID
- 59561-202_e90ddf21-87ce-462b-8344-5a578b17d52c
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN
- Dosage form
- SOLUTION
- Route
- ORAL
- Labeler
- Caribe Natural, LLC
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2015-11-05
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 20 mg/10mL; mg/10mL
- NDC exclude flag
- E
- Listing certified through
- 2017-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 59561-202-04 | BRONCO SILEN-DM | 118 mL in 1 BOTTLE, PLASTIC | SOLUTION | 118 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| CITRIC ACID MONOHYDRATE | INACTIVE INGREDIENT | 2968PHW8QP | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%) | INACTIVE INGREDIENT | 2Q40985DRM | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| MENTHOL, UNSPECIFIED FORM | INACTIVE INGREDIENT | L7T10EIP3A | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| POLYETHYLENE GLYCOLS | INACTIVE INGREDIENT | 3WJQ0SDW1A | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| PROPYLPARABEN | INACTIVE INGREDIENT | Z8IX2SC1OH | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| SODIUM CITRATE | INACTIVE INGREDIENT | 1Q73Q2JULR | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 59561-202 | BRONCO SILEN-DM (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN) SOLUTION [CARIBE NATURAL, LLC] | 1 | Legacy NDC, 1 package rows | 20151112_baf96bf1-7e70-4f08-9514-6f0d4cde6d88.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 59561-202-04 | 59561020204 | 118 mL in 1 BOTTLE, PLASTIC | 118 ml | Historical |