NDC 58552-131

Giltuss Childrens Cough and Cold

Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride

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

• Product ID: 58552-131_852b77ae-a59a-3ead-e053-2a91aa0a54bd
• NDC: 58552-131
• Product Type: Human Otc Drug
• Proprietary Name: Giltuss Childrens Cough and Cold
• Generic Name: Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-11-07
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Gil Pharmaceutical Corp
• Substance Name: DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 8 mg/2.5mL; mg/2.5mL; mg/2.5mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58552-131-04

1 BOTTLE in 1 CARTON (58552-131-04) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2018-11-07
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58552-131-04 [58552013104]

Giltuss Childrens Cough and Cold SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-11-07

Drug Details

Active Ingredients

Ingredient	Strength
DEXTROMETHORPHAN HYDROBROMIDE	7.5 mg/2.5mL

OpenFDA Data

• SPL SET ID: 852b77ae-a5ac-3ead-e053-2a91aa0a54bd
• Manufacturer:
  • Gil Pharmaceutical Corp
• UNII:
  • 04JA59TNSJ
  • 9D2RTI9KYH
  • 495W7451VQ
• RxNorm Concept Unique ID - RxCUI:
  • 1251031

NDC Crossover Matching brand name "Giltuss Childrens Cough and Cold" or generic name "Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
58552-131	Giltuss Childrens Cough and Cold	Giltuss Childrens Cough and Cold
0113-7400	basic care mucus relief severe congestion and cough	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
49963-381	Brontuss	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
49963-813	Brontuss	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
49963-913	Brontuss	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41520-937	CareOne Tussin CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
11584-1046	DESPEC	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
11584-1110	Despec	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41163-388	equaline tussin	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
49035-516	Equate Tussin CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
30142-454	fast mucus relief	dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
24385-904	Good Neighbor Pharmacy Tussin CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0113-0703	Good Sense Tussin CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
37808-317	H E B MAX SEVERE CONGESTION and COUGH	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
41520-037	Mucus Relief	dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-0337	Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
0363-0681	Mucus Relief Severe Congestion and Cough	dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
41250-605	multi symptom cold	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
41190-516	ShopRite Adult Tussin	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
49738-280	smart sense multi symptom cold	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
49873-306	Stona Cough	dextromethorphan hydrobromide, guaifenesin, phenylephrine hydrochloride
49348-737	SUNMARK TUSSIN CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
36800-516	topcare tussin CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
50066-504	Tukol Multi Symptom Cold	DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
30142-516	tussin cf	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
37012-516	Tussin CF	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
0363-0516	Wal Tussin	Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride