NDC 53041-617

Tussnex FM Severe cough and congestion

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Tussnex FM Severe cough and congestion is a Oral Liquid in the Human Otc Drug category. It is labeled and distributed by Guardian Drug Company. The primary component is Dextromethorphan Hydrobromide; Guaifenesin; Phenylephrine Hydrochloride.

• Product ID: 53041-617_2d85a0db-2a04-48d5-ad40-e4cb65aa7e67
• NDC: 53041-617
• Product Type: Human Otc Drug
• Proprietary Name: Tussnex FM Severe cough and congestion
• Generic Name: Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Liquid
• Route of Administration: ORAL
• Marketing Start Date: 2012-12-01
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Guardian Drug Company
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 20 mg/20mL; mg/20mL; mg/20mL
• Pharm Classes: Adrenergic alpha1-Agonists [MoA], 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], alpha-1 Adrenergic Agonist [EPC]
• NDC Exclude Flag: N
• Listing Certified Through: 2023-12-31

Packaging

NDC 53041-617-58

177 mL in 1 BOTTLE (53041-617-58)

• Marketing Start Date: 2012-12-01
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 53041-617-58 [53041061758]

Tussnex FM Severe cough and congestion LIQUID

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Marketing Start Date: 2012-12-01

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	20 mg/20mL

OpenFDA Data

• SPL SET ID: 387df403-7803-4031-915e-8de9b103a162
• Manufacturer:
  • Guardian Drug Company
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1043543
• UPC Code:
  • 0053041617584

NDC Crossover Matching brand name "Tussnex FM Severe cough and congestion" or generic name "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
53041-617	Tussnex FM Severe cough and congestion	Tussnex FM Severe cough and congestion
11026-2780	Broncotron PED	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
11026-2790	Broncotron PED	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
30142-839	Childrens Mucus Relief	dextromethorphan HBr, guaifenesin, phenylephrine HCl
11822-0839	childrens mucus relief multi symptom cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
0363-9839	childrens multi symptom cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
41163-839	equaline childrens mucus relief	dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0839	Good Sense Childrens Mucus Relief	dextromethorphan HBr, guaifenesin, phenylephrine HCl
0113-0296	good sense tussin	dextromethorphan hbr, guaifenesin, phenylephrine hcl
37808-407	Mucus Multi Symptom Cold Relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
41250-137	Mucus Relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-6480	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
11822-3370	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
11822-3722	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCL
36800-037	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
41163-047	Mucus Relief Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
41163-037	Mucus Relief Severe Congestion Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
0363-6048	Severe Congestion and Cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
21130-817	Severe Congestion and Cough Relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
21130-272	Signature Care Childrens Multi Symptom Cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
36800-839	topcare childrens mucus relief multi symptom cold	dextromethorphan HBr, guaifenesin, phenylephrine HCl
36800-220	Topcare mucus relief	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
36800-296	topcare tussin cf max	dextromethorphan hbr, guaifenesin, phenylephrine hcl
15127-412	Tussin CF	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl
11673-747	Up and Up mucus relief severe congestion and cough	Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl