vicks formula 44 vapocool cough and chest congestion

Generic: acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin

Labeler: the procter & gamble manufacturing company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name vicks formula 44 vapocool cough and chest congestion
Generic Name acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin
Labeler the procter & gamble manufacturing company
Dosage Form SOLUTION
Routes
ORAL
Active Ingredients

acetaminophen 650 mg/30mL, dextromethorphan hydrobromide 20 mg/30mL, guaifenesin 400 mg/30mL, phenylephrine hydrochloride 10 mg/30mL

Manufacturer
The Procter & Gamble Manufacturing Company

Identifiers & Regulatory

Product NDC 69423-964
Product ID 69423-964_402e337c-3129-96ea-e063-6294a90ad155
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M012
Listing Expiration 2026-12-31
Marketing Start 2020-10-01

Pharmacologic Class

Established (EPC)
expectorant [epc]
Physiologic Effect
decreased respiratory secretion viscosity [pe] increased respiratory secretions [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 69423964
Hyphenated Format 69423-964

Supplemental Identifiers

RxCUI
1369842
UPC
0323900039780
UNII
362O9ITL9D 9D2RTI9KYH 495W7451VQ 04JA59TNSJ
NUI
N0000193956 N0000008867 N0000009560

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name vicks formula 44 vapocool cough and chest congestion (source: ndc)
Generic Name acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin (source: ndc)
Application Number M012 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 650 mg/30mL
  • 20 mg/30mL
  • 400 mg/30mL
  • 10 mg/30mL
source: ndc
Packaging
  • 236 mL in 1 BOTTLE, PLASTIC (69423-964-08)
source: ndc

Packages (1)

Ingredients (4)

acetaminophen (650 mg/30mL) dextromethorphan hydrobromide (20 mg/30mL) guaifenesin (400 mg/30mL) phenylephrine hydrochloride (10 mg/30mL)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["ORAL"], "spl_id": "402e337c-3129-96ea-e063-6294a90ad155", "openfda": {"nui": ["N0000193956", "N0000008867", "N0000009560"], "upc": ["0323900039780"], "unii": ["362O9ITL9D", "9D2RTI9KYH", "495W7451VQ", "04JA59TNSJ"], "rxcui": ["1369842"], "spl_set_id": ["d3bfce81-9e6d-6741-e053-2a95a90af183"], "pharm_class_pe": ["Decreased Respiratory Secretion Viscosity [PE]", "Increased Respiratory Secretions [PE]"], "pharm_class_epc": ["Expectorant [EPC]"], "manufacturer_name": ["The Procter & Gamble Manufacturing Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "236 mL in 1 BOTTLE, PLASTIC (69423-964-08)", "package_ndc": "69423-964-08", "marketing_start_date": "20201001"}], "brand_name": "Vicks Formula 44 VapoCool Cough and Chest Congestion", "product_id": "69423-964_402e337c-3129-96ea-e063-6294a90ad155", "dosage_form": "SOLUTION", "pharm_class": ["Adrenergic alpha1-Agonists [MoA]", "Decreased Respiratory Secretion Viscosity [PE]", "Expectorant [EPC]", "Increased Respiratory Secretions [PE]", "Sigma-1 Agonist [EPC]", "Sigma-1 Receptor Agonists [MoA]", "Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC]", "Uncompetitive NMDA Receptor Antagonists [MoA]", "alpha-1 Adrenergic Agonist [EPC]"], "product_ndc": "69423-964", "generic_name": "acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin", "labeler_name": "The Procter & Gamble Manufacturing Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Vicks Formula 44", "brand_name_suffix": "VapoCool Cough and Chest Congestion", "active_ingredients": [{"name": "ACETAMINOPHEN", "strength": "650 mg/30mL"}, {"name": "DEXTROMETHORPHAN HYDROBROMIDE", "strength": "20 mg/30mL"}, {"name": "GUAIFENESIN", "strength": "400 mg/30mL"}, {"name": "PHENYLEPHRINE HYDROCHLORIDE", "strength": "10 mg/30mL"}], "application_number": "M012", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20201001", "listing_expiration_date": "20261231"}