FDA.reportPublic FDA data

Vicks Formula 44

Product NDC
69423-964
11-digit product format
694230964
Labeler code
69423
Product ID
69423-964_eb5399d1-373a-7876-e053-2995a90a2104
Type
HUMAN OTC DRUG
Nonproprietary name
acetaminophen, phenylephrine hydrochloride, dextromethorphan hydrobromide, and guaifenesin
Dosage form
SOLUTION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2020-10-01
Marketing end
0000-00-00
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
650 mg/30mL; mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
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]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct69423-964DDiscontinued by firm2026-10-23
excluded packagepackage69423-96469423-964-08DDiscontinued by firm2026-10-23

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-964-08Vicks Formula 44VapoCool Cough and Chest Congestion236 mL in 1 BOTTLE, PLASTICSOLUTION23611

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-964VICKS FORMULA 44 VAPOCOOL COUGH AND CHEST CONGESTION (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND GUAIFENESIN) SOLUTION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Legacy NDC, 1 package rows20241012_d3bfce81-9e6d-6741-e053-2a95a90af183.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 174 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
StonaACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESato Pharmaceutical Co., Ltd.8b89f50d-88f8-4773-92ea-5ada617660562023-11-28WarningsExact identifier
application number: M012
StonaDEXTROMETHORPHAN HYDROBROMIDESato Pharmaceutical Co., Ltd.1ccc9e56-32a4-450f-8412-5814b6aef2852023-11-28WarningsExact identifier
application number: M012
Neo-Synephrine MaximumPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab8682a4-1f66-6709-e053-2995a90a8b4a2023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine RegularPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INCab860c10-b8cf-3f92-e053-2a95a90a73172023-11-16WarningsExact identifier
application number: M012
Neo-Synephrine MildPHENYLEPHRINE HYDROCHLORIDEBF ASCHER AND CO INC9b8e9162-e4da-14d9-e053-2995a90a22692023-11-16WarningsExact identifier
application number: M012
Universal Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUSUniversal Distribution Center LLCb1d25572-da21-408d-aab3-3a0741dfff122023-11-16WarningsExact identifier
application number: M012
Daytime Cold and Flu Severe, Caseys 4googACETAMINOPHEN, PHENYLEPHRINE, DEXTROMETHORPHAN HBR, GUAIFENESIN TABLET, FILM COATEDLil' Drug Store Products, Inc.0334259d-587e-b2d5-e063-6394a90a3e562023-11-14WarningsExact identifier
application number: M012
Stona CoughDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINSato Pharmaceutical Co., Ltd.0b638db4-5ed3-4665-abcd-f95e677adbd82023-11-12WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc6c90b415-4c5f-49e5-beb6-4cf225797b212023-11-06WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Inc8b8582c0-8aef-482f-9738-2f1d4e325d642023-11-06WarningsExact identifier
application number: M012
Cold and Flu Severe Daytime/NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATETopco Associates LLC27ade5f8-2003-4dc6-9244-42676791e1f82023-11-06WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDEJones Healthcare Group - Packaging Services, Incec2070df-8a8a-4cd1-8830-62655433fb3b2023-11-05WarningsExact identifier
application number: M012
Daytime Nighttime Ultra Concentrated Cold and FluDAYTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR AND NIGHTTIME - ACETAMINOPHEN, DEXTROMETHROPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION093eed84-79b1-7914-e063-6394a90a37af2023-11-03WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff68377-2273-6c6c-e053-2995a90a36b22023-11-03WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLC096bbcaa-fce1-0fc2-e063-6294a90ad5972023-11-03WarningsExact identifier
application number: M012
TopCare Nite Time SEVERE Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDETopco Associates LLCadc8edf5-ebbe-4d94-9018-aa0dbe1181122023-11-03WarningsExact identifier
application number: M012
MUCOSAGUAIFENESINTIME CAP LABORATORIES,INCd34ef2e8-adc2-48e5-a572-e354937daec62023-11-02WarningsExact identifier
application number: M012
Daytime Severe and Nighttime Severe cold and fluDAYTIME SEVERE - ACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN AND NIGHTTIME SEVERE-ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATETARGET CORPORATION09286d15-b63f-a9de-e063-6294a90ab9482023-11-02WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEAMERIFOODS TRADING COMPANYf6cece6c-23e4-7811-e053-6394a90a106a2023-11-02WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDERETAIL BUSINESS SERVICES , LLC.eb64750f-19ac-655f-e053-2995a90a33b52023-11-02WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNd3bfce81-9e6d-6741-e053-2a95a90af18311
1369842acetaminophen 21.7 MG/ML / dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDd3bfce81-9e6d-6741-e053-2a95a90af18311
1369842acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / phenylephrine HCl 5 MG per 15 ML Oral SolutionSYd3bfce81-9e6d-6741-e053-2a95a90af18311
1369842acetaminophen 650 MG / dextromethorphan HBr 20 MG / guaifenesin 400 MG / phenylephrine HCl 10 MG per 30 ML Oral SolutionSYd3bfce81-9e6d-6741-e053-2a95a90af18311
1369842APAP 21.7 MG/ML / Dextromethorphan Hydrobromide 0.667 MG/ML / Guaifenesin 13.3 MG/ML / Phenylephrine Hydrochloride 0.333 MG/ML Oral SolutionSYd3bfce81-9e6d-6741-e053-2a95a90af18311

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-964-0869423096408236 mL in 1 BOTTLE, PLASTIC (69423-964-08) 236 ml2018-07-100000-00-00NoNoCurrent