BRONCOCHEM
- Product NDC
- 65131-111
- 11-digit product format
- 651310111
- Labeler code
- 65131
- Product ID
- 65131-111_75397c61-93f4-4d4d-9e3a-81107ecb0932
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Acetaminophen-Dextromethorphan HBr-Phenylephrine HCl-Chlorpheniramine Maleate
- Dosage form
- TABLET, COATED
- Route
- ORAL
- Labeler
- LABORATORIO MAGNACHEM INTERNATIONAL SRL
- Application
- C200263
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2010-01-01
- Substance
- ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
- Active strength
- 325; 3; 30; 5 mg/1; mg/1; mg/1; mg/1
- 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
- COLD AND FLU CAPLETS
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ACETAMINOPHEN | 325 mg/1 |
| CHLORPHENIRAMINE MALEATE | 3 mg/1 |
| DEXTROMETHORPHAN HYDROBROMIDE | 30 mg/1 |
| PHENYLEPHRINE HYDROCHLORIDE | 5 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 362O9ITL9D, V1Q0O9OJ9Z, 9D2RTI9KYH, 04JA59TNSJ |
| Rxcui | 1744049 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 65131-111-95 | BRONCOCHEMCOLD AND FLU CAPLETS | 50 in 1 BOX | TABLET, COATED | 50 | | 4 |
| 65131-111-95 | BRONCOCHEMCOLD AND FLU CAPLETS | 2 in 1 POUCH | TABLET, COATED | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 65131-111 | BRONCOCHEM COLD AND FLU CAPLETS (ACETAMINOPHEN-DEXTROMETHORPHAN HBR-PHENYLEPHRINE HCL-CHLORPHENIRAMINE MALEATE) TABLET, COATED [LABORATORIO MAGNACHEM INTERNATIONAL SRL] | 4 | Current NDC, Legacy NDC, 2 package rows | 20241127_ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 65131-111-21 | 65131011121 | 12 BOX in 1 BOX (65131-111-21) > 50 POUCH in 1 BOX (65131-111-95) > 2 TABLET, COATED in 1 POUCH | 12 box | 2016-12-30 | 0000-00-00 | No | No | Current |
| 65131-111-95 | 65131011195 | 50 POUCH in 1 BOX (65131-111-95) / 2 TABLET, COATED in 1 POUCH | 50 pouch | 2024-01-02 | | No | No | Current |