NDC 58552-331

Giltuss Cough and Cold

Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl

Giltuss Cough and Cold is a Oral Tablet in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Guaifenesin; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 58552-331_8590fcc9-c0de-f43b-e053-2991aa0a692e
• NDC: 58552-331
• Product Type: Human Otc Drug
• Proprietary Name: Giltuss Cough and Cold
• Generic Name: Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl
• Dosage Form: Tablet
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-11
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Gil Pharmaceutical Corp
• Substance Name: GUAIFENESIN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 388 mg/1; mg/1; mg/1
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58552-331-20

2 BLISTER PACK in 1 CARTON (58552-331-20) > 10 TABLET in 1 BLISTER PACK

• Marketing Start Date: 2018-10-11
• NDC Exclude Flag: N
• Sample Package?: Y

NDC SPL Data Element Entries

NDC 58552-331-20 [58552033120]

Giltuss Cough and Cold TABLET

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: EA
• Marketing Start Date: 2018-10-11

Drug Details

Active Ingredients

Ingredient	Strength
GUAIFENESIN	388 mg/1

OpenFDA Data

• SPL SET ID: 8590fcc9-c0dd-f43b-e053-2991aa0a692e
• Manufacturer:
  • Gil Pharmaceutical Corp
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 899263

NDC Crossover Matching brand name "Giltuss Cough and Cold" or generic name "Dextromethorphan Hbr, Guaifenesin, Phenylephrine Hcl"

NDC	Brand Name	Generic Name
58552-331	Giltuss Cough and Cold	Giltuss Cough and Cold
58552-130	Giltuss Cough and Cold	Giltuss Cough and Cold
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