Broncomar
- Product NDC
- 53113-216
- 11-digit product format
- 531130216
- Labeler code
- 53113
- Product ID
- 53113-216_9093948c-6ef7-48ce-b023-8d979a924cde
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan HBr, Guaifenesin
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Gadal Laboratories Inc
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2014-06-01
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
- Active strength
- 30 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 |
|---|
| 53113-216-06 | BroncomarMaximum | 177 mL in 1 BOTTLE | LIQUID | 177 | | 1 |
| 53113-216-06 | BroncomarMaximum | 1 in 1 CARTON | LIQUID | 1 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| DEXTROMETHORPHAN HYDROBROMIDE | ACTIVE INGREDIENT | 9D2RTI9KYH | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| GUAIFENESIN | ACTIVE INGREDIENT | 495W7451VQ | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| DEXTROMETHORPHAN | ACTIVE MOIETY | 7355X3ROTS | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| GUAIFENESIN | ACTIVE MOIETY | 495W7451VQ | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| ALOE VERA WHOLE | INACTIVE INGREDIENT | KIZ4X2EHYX | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| ANHYDROUS CITRIC ACID | INACTIVE INGREDIENT | XF417D3PSL | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| FD&C RED NO. 40 | INACTIVE INGREDIENT | WZB9127XOA | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| GLYCERIN | INACTIVE INGREDIENT | PDC6A3C0OX | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| HYDROXYMETHYL CELLULOSE | INACTIVE INGREDIENT | 273FM27VK1 | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| SODIUM BENZOATE | INACTIVE INGREDIENT | OJ245FE5EU | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| SORBITOL | INACTIVE INGREDIENT | 506T60A25R | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| SUCRALOSE | INACTIVE INGREDIENT | 96K6UQ3ZD4 | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 53113-216 | BRONCOMAR MAXIMUM (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [GADAL LABORATORIES INC] | 1 | Legacy NDC, 2 package rows | 20140613_afbee087-62dc-4f5d-8155-2d6c1de320ed.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 53113-216-06 | 53113021606 | 177 mL in 1 BOTTLE | 177 ml | Historical |