NDC 53145-040

Breacold Adult

Guaifenesin, Dextromethorphan Hbr

Breacold Adult is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Menper Distributors, Inc.. The primary component is Dextromethorphan Hydrobromide; Guaifenesin.

• Product ID: 53145-040_0aeb98ab-943c-4f17-a025-89e7a4f85194
• NDC: 53145-040
• Product Type: Human Otc Drug
• Proprietary Name: Breacold Adult
• Generic Name: Guaifenesin, Dextromethorphan Hbr
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2012-02-21
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Menper Distributors, Inc.
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
• Active Ingredient Strength: 20 mg/10mL; mg/10mL
• Pharm Classes: Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 53145-040-04

1 BOTTLE in 1 CARTON (53145-040-04) > 120 mL in 1 BOTTLE

• Marketing Start Date: 2012-02-21
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53145-040-04 [53145004004]

Breacold Adult LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-02-21
• Inactivation Date: 2020-01-31
• Reactivation Date: 2020-03-15

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	100 mg/5mL

OpenFDA Data

• SPL SET ID: 69878145-6ac2-44c1-8eb6-56df46dd89f1
• Manufacturer:
  • Menper Distributors, Inc.
• UNII:
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 996520

NDC Crossover Matching brand name "Breacold Adult" or generic name "Guaifenesin, Dextromethorphan Hbr"

NDC	Brand Name	Generic Name
53145-040	Breacold Adult	Breacold Adult
47682-217	Medique Guaicon DMS	Guaifenesin, Dextromethorphan Hbr
0904-6233	MUCUS RELIEF DM	GUAIFENESIN, DEXTROMETHORPHAN HBr
11822-0733	Mucus Relief DM	Guaifenesin, Dextromethorphan HBr
11822-7340	Mucus Relief DM	Guaifenesin, Dextromethorphan HBr
21130-933	Mucus Relief DM	Guaifenesin, Dextromethorphan HBr
37012-729	Mucus Relief DM	Guaifenesin, Dextromethorphan HBr
49035-825	Mucus Relief DM	Guaifenesin, Dextromethorphan HBr
11673-833	Mucus Relief DM Extended Release	Guaifenesin, Dextromethorphan HBr
0363-0437	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
0363-0733	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
0536-1161	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
0536-1213	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
37012-730	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
41250-633	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
41250-934	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
49035-824	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr
50090-6020	Mucus Relief DM Extended Release Caplets	Guaifenesin, Dextromethorphan HBr