BRONCOCHEM
- Product NDC
- 65131-116
- 11-digit product format
- 651310116
- Labeler code
- 65131
- Product ID
- 65131-116_383c518a-2d0c-4346-894c-9e089094d612
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBr-GUAIFENESIN-PHENYLEPHRINE HCl
- Dosage form
- SYRUP
- Route
- ORAL
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Application
- part343
- Marketing category
- OTC MONOGRAPH NOT FINAL
- Marketing start
- 2016-12-30
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 250; 4; 13.33; 200; 5 mg/10mL; mg/10mL; mg/10mL; mg/10mL; mg/10mL
- Pharmacologic classes
- Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA], alpha-1 Adrenergic Agonist [EPC]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- BRONCOCHEM
- Brand name suffix
- EXPECTORANT II
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 250 mg/10mL |
| CHLORPHENIRAMINE MALEATE | 4 mg/10mL |
| DEXTROMETHORPHAN HYDROBROMIDE | 13.33 mg/10mL |
| GUAIFENESIN | 200 mg/10mL |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/10mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 495W7451VQ, 04JA59TNSJ |
| Rxcui | 1743369 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65131-116-87 | BRONCOCHEMEXPECTORANT II | 1 in 1 BOX | SYRUP | 1 | | 2 |
| 65131-116-87 | BRONCOCHEMEXPECTORANT II | 120 mL in 1 BOTTLE, PLASTIC | SYRUP | 120 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65131-116 | BRONCOCHEM EXPECTORANT II (ACETAMINOPHEN-CHLORPHENIRAMINE MALEATE-DEXTROMETHORPHAN HBR-GUAIFENESIN-PHENYLEPHRINE HCL) SYRUP [LABORATORIO MAGNACHEM INTERNATIONAL SRL] | 2 | Current NDC, Legacy NDC, 2 package rows | 20161230_d0426469-9dd1-4bd1-b81e-69d33187daa2.zip |
DailyMed RxNorm Mappings#
RxCUI, RxNorm string, TTY table| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|
| 1743369 | acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 13.33 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 10 mL Oral Solution | PSN | d0426469-9dd1-4bd1-b81e-69d33187daa2 | 2 |
| 1743369 | acetaminophen 25 MG/ML / chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 1.33 MG/ML / guaifenesin 20 MG/ML / phenylephrine hydrochloride 0.5 MG/ML Oral Solution | SCD | d0426469-9dd1-4bd1-b81e-69d33187daa2 | 2 |
| 1743369 | acetaminophen 250 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 13.33 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 10 ML Oral Solution | SY | d0426469-9dd1-4bd1-b81e-69d33187daa2 | 2 |
| 1743369 | APAP 25 MG/ML / Chlorpheniramine Maleate 0.4 MG/ML / Dextromethorphan Hydrobromide 1.33 MG/ML / Guaifenesin 20 MG/ML / Phenylephrine Hydrochloride 0.5 MG/ML Oral Solution | SY | d0426469-9dd1-4bd1-b81e-69d33187daa2 | 2 |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65131-116-87 | 65131011687 | 1 BOTTLE, PLASTIC in 1 BOX (65131-116-87) / 120 mL in 1 BOTTLE, PLASTIC | 2016-12-30 | 0000-00-00 | No | No | Current |