NDC 58552-138

Giltuss Allergy Plus Cough and Congestion

Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride

Giltuss Allergy Plus Cough and Congestion is a Oral Solution in the Human Otc Drug category. It is labeled and distributed by Gil Pharmaceutical Corp. The primary component is Chlorpheniramine Maleate; Dextromethorphan Hydrobromide; Phenylephrine Hydrochloride.

• Product ID: 58552-138_85065cf3-386e-22d5-e053-2a91aa0a72da
• NDC: 58552-138
• Product Type: Human Otc Drug
• Proprietary Name: Giltuss Allergy Plus Cough and Congestion
• Generic Name: Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
• Dosage Form: Solution
• Route of Administration: ORAL
• Marketing Start Date: 2018-10-02
• Marketing Category: OTC MONOGRAPH FINAL / OTC MONOGRAPH FINAL
• Application Number: part341
• Labeler Name: Gil Pharmaceutical Corp
• Substance Name: CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
• Active Ingredient Strength: 4 mg/10mL; mg/10mL; mg/10mL
• NDC Exclude Flag: N
• Listing Certified Through: 2020-12-31

Packaging

NDC 58552-138-04

1 BOTTLE in 1 CARTON (58552-138-04) > 118 mL in 1 BOTTLE

• Marketing Start Date: 2018-10-02
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 58552-138-04 [58552013804]

Giltuss Allergy Plus Cough and Congestion SOLUTION

• Marketing Category: OTC monograph final
• Application Number: part341
• Product Type: HUMAN OTC DRUG
• Billing Unit: ML
• Marketing Start Date: 2018-10-02

Drug Details

Active Ingredients

Ingredient	Strength
CHLORPHENIRAMINE MALEATE	4 mg/10mL

OpenFDA Data

• SPL SET ID: 85065cf3-386d-22d5-e053-2a91aa0a72da
• Manufacturer:
  • Gil Pharmaceutical Corp
• UNII:
  • V1Q0O9OJ9Z
  • 04JA59TNSJ
  • 9D2RTI9KYH
• RxNorm Concept Unique ID - RxCUI:
  • 1363752

NDC Crossover Matching brand name "Giltuss Allergy Plus Cough and Congestion" or generic name "Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride"

NDC	Brand Name	Generic Name
45737-250	BIO-RYTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
49963-532	Bronkids	Chlorpheniramine Maleate, Dextromethorphan Hydrobromide, Phenylephrine Hydrochloride
52083-650	GENCONTUSS	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
58552-138	Giltuss Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
58552-139	Giltuss Childrens Allergy Plus	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE
76117-001	Rycontuss	CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDE