Brontuss
- Product NDC
- 49963-381
- 11-digit product format
- 499630381
- Labeler code
- 49963
- Product ID
- 49963-381_148d8c18-9501-4127-9357-24372c7a84c3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- Portal Pharmaceutical
- Application
- part341
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2011-12-22
- Marketing end
- 0000-00-00
- Substance
- DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 15 mg/5mL; mg/5mL; mg/5mL
- 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 |
|---|
| 49963-381-01 | BrontussSF-NR | 30 mL in 1 BOTTLE | LIQUID | 30 | | 1 |
| 49963-381-04 | BrontussSF-NR | 118 mL in 1 BOTTLE | LIQUID | 118 | | 1 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| Dextromethorphan Hydrobromide | ACTIVE INGREDIENT | 9D2RTI9KYH | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Guaifenesin | ACTIVE INGREDIENT | 495W7451VQ | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Phenylephrine Hydrochloride | ACTIVE INGREDIENT | 04JA59TNSJ | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Dextromethorphan | ACTIVE MOIETY | 7355X3ROTS | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Guaifenesin | ACTIVE MOIETY | 495W7451VQ | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Phenylephrine | ACTIVE MOIETY | 1WS297W6MV | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Citric Acid Monohydrate | INACTIVE INGREDIENT | 2968PHW8QP | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Glycerin | INACTIVE INGREDIENT | PDC6A3C0OX | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Saccharin Sodium | INACTIVE INGREDIENT | SB8ZUX40TY | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Sodium Citrate | INACTIVE INGREDIENT | 1Q73Q2JULR | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Sorbitol | INACTIVE INGREDIENT | 506T60A25R | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
| Water | INACTIVE INGREDIENT | 059QF0KO0R | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49963-381 | BRONTUSS SF-NR (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE) LIQUID [PORTAL PHARMACEUTICAL] | 1 | Legacy NDC, 2 package rows | 20120309_5732c79c-9717-498b-b511-f6da2dfbb867.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Status |
|---|
| 49963-381-01 | 49963038101 | 30 mL in 1 BOTTLE | 30 ml | Historical |
| 49963-381-04 | 49963038104 | 118 mL in 1 BOTTLE | 118 ml | Historical |