Vicks Formula 44 Solution
NDC Package 69423-964-08
Package Information
Vicks Formula 44 (acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin) solution is take only as directedonly use the dose cup provideddo not exceed 4 doses per 24 hrsadults & children 12 yrs & over 30 mL every 4 hrs children 4 to under 12 yrs ask a doctor children under 4 yrs do not use. This formulation utilizes a solution delivery system. Marketed by The Procter & Gamble Manufacturing Company, this product is identified by NDC 69423-964 and is authorized under FDA application M012.
Identification & Billing
- RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral Solution
- RxCUI: 1369842 - acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral Solution
- RxCUI: 1369842 - acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral Solution
- RxCUI: 1369842 - acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral Solution
- RxCUI: 1369842 - APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral Solution
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
- 69423 - The Procter & Gamble Manufacturing Company
- 69423-964 - Vicks Formula 44
- 69423-964-08 - 236 mL in 1 BOTTLE, PLASTIC
- 69423-964 - Vicks Formula 44
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 69423-964-08 identifies a specific commercial package of 236 ml in 1 bottle, plastic of Vicks Formula 44 Vapocool Cough And Chest Congestion, a human over the counter drug labeled by The Procter & Gamble Manufacturing Company. This solution is formulated for oral use and contains acetaminophen; 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 The Procter & Gamble Manufacturing Company on October 01, 2020. The current certification is valid through December 31, 2026.
How is this The Procter & Gamble Manufacturing Company product billed for insurance claims?
For medical billing and reimbursement, this package follows the 11-digit CMS format: 69423096408. 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.