Giltuss Cough And Cold Tablet
NDC Package 58552-331-20
Package Information
Giltuss Cough And Cold (dextromethorphan hbr, guaifenesin, phenylephrine hcl) tablets is usesTemporarily relieves the symptoms associated with a cough, the common cold, hay fever, or other upper respiratory allergies. This formulation utilizes a tablet delivery system. Marketed by Gil Pharmaceutical Corp, this product is identified by NDC 58552-331 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 2167784 - dextromethorphan HBr 28 MG / guaiFENesin 388 MG / phenylephrine HCl 10 MG Oral Tablet
- RxCUI: 2167784 - dextromethorphan hydrobromide 28 MG / guaifenesin 388 MG / phenylephrine hydrochloride 10 MG Oral Tablet
Clinical Specifications
- Adrenergic alpha1-Agonists - [MoA] (Mechanism of Action)
- Decreased Respiratory Secretion Viscosity - [PE] (Physiologic Effect)
- Expectorant - [EPC] (Established Pharmacologic Class)
- Increased Respiratory Secretions - [PE] (Physiologic Effect)
- 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
- 58552-331 - Giltuss Cough And Cold
- 58552-331-20 - 2 BLISTER PACK in 1 CARTON / 10 TABLET in 1 BLISTER PACK
- 58552-331 - Giltuss Cough And Cold
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 58552-331-20 identifies a specific commercial package of 2 blister pack in 1 carton / 10 tablet in 1 blister pack of Giltuss Cough And Cold, a human over the counter drug labeled by Gil Pharmaceutical Corp. This product is billed for "EA" each discreet unit and contains an estimated amount of 2 billable units per package. This tablet is formulated for oral use and contains dextromethorphan hydrobromide; guaifenesin; 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 April 01, 2021. 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: 58552033120. Quantities are measured in per "each", products billed on a per each basis are usually products dispensed in discreet units.. There are 2 total billable units per package. 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.