NDC 65131-111
BRONCOCHEM COLD AND FLU CAPLETS
Acetaminophen-dextromethorphan Hbr-phenylephrine Hcl-chlorpheniramine Maleate
BRONCOCHEM COLD AND FLU CAPLETS is a Oral Tablet, Coated in the Human Otc Drug category. It is labeled and distributed by Labotorio Magnachem International Srl. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride; Chlorpheniramine Maleate.
| Product ID | 65131-111_ade271a2-acb3-481c-98f6-4d6861d0737a |
| NDC | 65131-111 |
| Product Type | Human Otc Drug |
| Proprietary Name | BRONCOCHEM COLD AND FLU CAPLETS |
| Generic Name | Acetaminophen-dextromethorphan Hbr-phenylephrine Hcl-chlorpheniramine Maleate |
| Dosage Form | Tablet, Coated |
| Route of Administration | ORAL |
| Marketing Start Date | 2010-01-01 |
| Marketing Category | OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL |
| Application Number | part341 |
| Labeler Name | LABOTORIO MAGNACHEM INTERNATIONAL SRL |
| Substance Name | ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; CHLORPHENIRAMINE MALEATE |
| Active Ingredient Strength | 325 mg/1; mg/1; mg/1; mg/1 |
| NDC Exclude Flag | N |
| Listing Certified Through | 2020-12-31 |
Packaging
NDC 65131-111-21
12 BOX in 1 BOX (65131-111-21) > 50 POUCH in 1 BOX (65131-111-95) > 2 TABLET, COATED in 1 POUCH
| Marketing Start Date | 2016-12-30 |
| NDC Exclude Flag | N |
| Sample Package? | N |
NDC SPL Data Element Entries
NDC 65131-111-95 [65131011195]
BRONCOCHEM COLD AND FLU CAPLETS TABLET, COATED
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2010-01-01 |
NDC 65131-111-21 [65131011121]
BRONCOCHEM COLD AND FLU CAPLETS TABLET, COATED
| Marketing Category | OTC monograph final |
| Application Number | part341 |
| Product Type | HUMAN OTC DRUG |
| Marketing Start Date | 2016-12-30 |
Drug Details
Active Ingredients
| Ingredient | Strength |
|---|---|
| ACETAMINOPHEN | 325 mg/1 |
OpenFDA Data
| SPL SET ID: | ac4f6a39-e455-4d33-8bb8-ae8dc6ebc2f6 |
| Manufacturer | |
| UNII | |
| RxNorm Concept Unique ID - RxCUI |
Trademark Results [BRONCOCHEM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 BRONCOCHEM 85365505 4102132 Live/Registered |
Global Corporation 2011-07-07 |
 BRONCOCHEM 75813839 2405940 Dead/Cancelled |
GLOBAL CORPORATION 1999-10-04 |
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.