NDC 53113-215

Broncomar

Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Broncomar is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Gadal Laboratories Inc. The primary component is Acetaminophen; Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 53113-215_c84aa6c7-3e51-4b6a-9fee-e6af3856f0ae
• NDC: 53113-215
• Product Type: Human Otc Drug
• Proprietary Name: Broncomar
• Generic Name: Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2014-06-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Gadal Laboratories Inc
• Substance Name: ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 250 mg/10mL; mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: E
• Listing Certified Through: 2017-12-31

Packaging

NDC 53113-215-06

1 BOTTLE in 1 CARTON (53113-215-06) > 177 mL in 1 BOTTLE

• Marketing Start Date: 2014-06-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53113-215-06 [53113021506]

Broncomar LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2014-06-01
• Inactivation Date: 2019-11-27

Drug Details

Active Ingredients

Ingredient	Strength
ACETAMINOPHEN	250 mg/10mL

OpenFDA Data

• SPL SET ID: 058cdaf3-ed98-44b2-9ecc-fd810dcac12e
• Manufacturer:
  • Gadal Laboratories Inc
• UNII:
  • 362O9ITL9D
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ

NDC Crossover Matching brand name "Broncomar" or generic name "Acetaminophen, Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
53113-215	Broncomar	Broncomar
0113-7603	Basic Care Daytime Cold and Flu Severe	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-7303	basic care mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0640	Cold and Flu	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0299	good sense cold and flu severe	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0234	good sense cold head congestion	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0381	Good Sense Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-1913	good sense mucus relief cold flu and sore throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0579	good sense severe cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0113-0548	Good Sense Severe Daytime	acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0603	Good Sense Severe Daytime Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0113-9007	Good Sense Severe Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-0616	Mucus Relief	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0538	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0719	Mucus Relief Cold Flu Sore Throat	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0372	Mucus Relief Plus	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0410	Mucus Relief Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0503	Severe Cold	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0603	Severe Cold and Flu	acetaminophen, dextromethorphan hbr, guaifenesin, phenylephrine hcl
0363-0524	Sinus Relief	Acetaminophen, Dextromethorphan HBR, Guaifenesin, Phenylephrine HCl
0067-8145	Theraflu ExpressMax Severe Cold and Flu Caplets	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0067-8132	Theraflu ExpressMax Severe Cold and Flu Syrup	Acetaminophen, Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-0051	Wal Tussin CF Max	Acetaminophen, dextromethorphan HBr, guaifenesin, phenylephrine HCl