Winco Foods Childrens Multi Symptom Cold Suspension
NDC Package 67091-355-18
Package Information
Winco Foods Childrens Multi Symptom Cold (dextromethorphan hydrobromide, guaifenesin, and phenylephrine hydrochloride) suspension is ▪do not give more than 6 doses in any 24-hour period▪measure only with dosing cup provided▪do not use dosing cup with other products▪dose as follows or as directed by a doctorAgeDosechildren 6 years to under 12 years of age10 mL every 4 hourschildren 4 to under 6 years of age5 mL every 4 hourschildren under 4 years of agedo not use. This formulation utilizes a suspension delivery system. Marketed by Winco Foods, Llc, this product is identified by NDC 67091-355 and is authorized under FDA application M012.
Identification & Billing
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
- 67091 - Winco Foods, Llc
- 67091-355 - Winco Foods Childrens Multi Symptom Cold
- 67091-355-18 - 1 BOTTLE in 1 CARTON / 118 mL in 1 BOTTLE
- 67091-355 - Winco Foods Childrens Multi Symptom 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 67091-355-18 identifies a specific commercial package of 1 bottle in 1 carton / 118 ml in 1 bottle of Winco Foods Childrens Multi Symptom Cold, a human over the counter drug labeled by Winco Foods, Llc. This suspension 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 Winco Foods, Llc on March 30, 2020. The current certification is valid through December 31, 2026.
How is this Winco Foods, Llc product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 67091035518. 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.