Giltuss Allergy Plus Solution
NDC Package 58552-138-04
Package Information
Giltuss Allergy Plus (chlorpheniramine maleate, dextromethorphan hydrobromide, phenylephrine hydrochloride) solution is usestemporarily relievescough due to minor throat and bronchial irritation associated with a cold or inhaled irritantsnasal congestion due to the common cold, hay fever or other upper respiratory allergiestemporarily relieves these symptoms due to hay fever (allergic rhinitis):runny nosesneezingitchy, watery eyesitching of the nose or throattemporarily restores freer breathing through the nose. This formulation utilizes a solution delivery system. Marketed by Gil Pharmaceutical Corp, this product is identified by NDC 58552-138 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1363752 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG in 5 mL Oral Solution
- RxCUI: 1363752 - chlorpheniramine maleate 0.4 MG/ML / dextromethorphan hydrobromide 2 MG/ML / phenylephrine hydrochloride 1 MG/ML Oral Solution
- RxCUI: 1363752 - chlorpheniramine maleate 2 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG per 5 ML Oral Solution
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Histamine H1 Receptor Antagonists - [MoA] (Mechanism of Action)
- Histamine-1 Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Agonist - [EPC] (Established Pharmacologic Class)
- Sigma-1 Receptor Agonists - [MoA] (Mechanism of Action)
- Uncompetitive N-methyl-D-aspartate Receptor Antagonist - [EPC] (Established Pharmacologic Class)
- Uncompetitive NMDA Receptor Antagonists - [MoA] (Mechanism of Action)
- alpha-1 Adrenergic Agonist - [EPC] (Established Pharmacologic Class)
Regulatory & Marketing
Hierarchy Structure
- 58552 - Gil Pharmaceutical Corp
- 58552-138 - Giltuss Allergy Plus
- 58552-138-04 - 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
- 58552-138 - Giltuss Allergy Plus
The NDC Directory contains ONLY information on final marketed drugs submitted to FDA electronically by labelers. A labeler might be a manufacturer, re-packager or re-labeler. The product information included in the NDC directory does not indicate that FDA has verified the information provided by the product labeler. Assigned NDC numbers are not in any way an indication of FDA approval of the product.
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Frequently Asked Questions
What is the distribution configuration for this product package?
The code 58552-138-04 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Giltuss Allergy Plus Cough And Congestion, a human over the counter drug labeled by Gil Pharmaceutical Corp. This solution is formulated for oral use and contains chlorpheniramine maleate; dextromethorphan hydrobromide; phenylephrine hydrochloride as the active substance.
Is this product currently listed with the FDA?
Yes, this product is active and verified within the NDC Directory. It was introduced to the market by Gil Pharmaceutical Corp on October 02, 2018. The current certification is valid through December 31, 2026.
How is this Gil Pharmaceutical Corp product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 58552013804. Quantities are measured in per "ml or milliliter", products billed per milliliter are usually products measured by liquid volume.. The table below illustrates the segment conversion from the 10-digit labeler code to the 11-digit provider format.
11-Digit Code Conversion
Billing payers usually require a 5-4-2 segment configuration. Below is the conversion from the 10-digit package format to the 11-digit billing format:
Note: The zero is added to the Product segment to maintain the 5-4-2 structure.