FDA.reportPublic FDA data

Vicks DayQuil

Product NDC
69423-922
11-digit product format
694230922
Labeler code
69423
Product ID
69423-922_5ce15ab8-4fc6-60ea-e063-6294a90ac606
Type
HUMAN OTC DRUG
Nonproprietary name
DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN and PHENYLEPHRINE HYDROCHLORIDE
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE; GUAIFENESIN
Active strength
10; 5; 200 mg/15mL; mg/15mL; mg/15mL
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks DayQuil
Brand name suffix
Cough DM plus Congestion
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
PHENYLEPHRINE HYDROCHLORIDE5 mg/15mL
GUAIFENESIN200 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-922-12Vicks DayQuilCough DM plus Congestion354 mL in 1 BOTTLE, PLASTICLIQUID3549

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-922VICKS DAYQUIL COUGH DM PLUS CONGESTION (DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN AND PHENYLEPHRINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 1 package rows20241013_c48359ee-6e52-841d-e053-2a95a90ae293.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 126 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens TussnexACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company19e9678d-ac34-4af8-a80f-d08fce0a5f0e2024-12-19WarningsExact identifier
application number: M012
Vaporising Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILNew Pride Corpf66476d5-036b-0b1c-e053-2a95a90a0a072024-12-19WarningsExact identifier
application number: M012
Chest Rub Vaporizing ActionMENTHOL AND CAMPHOR AND EUCALYPTUS OILSinghfam Corporationc6ea663a-9c4f-4d1a-a937-002806a8530a2024-12-19WarningsExact identifier
application number: M012
ELIZABETH HEALTH STYLE CHESTRUB VAPORIZING ACTIONCAMPHOR (SYNTHETIC), LEVOMENTHOL, EUCALYPTUSSinghfam Corporationf1e4caee-b50e-a0a6-e053-2a95a90aadce2024-12-19WarningsExact identifier
application number: M012
Leader Vapor Steam camphor (synthetic)CAMPHOR (SYNTHETIC)LEADER/Cardinal Health 110, Inc.ae580e6c-2efd-c788-e053-2995a90a33602024-12-19WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINStrategic Sourcing Service, LLC0b6689db-ea34-9a06-e063-6394a90abaf72024-12-19WarningsExact identifier
application number: M012
Medicated Chest RubCAMPHOR, MENTHOL, EUCALYPTUS OILJell Pharmaceuticals Pvt Ltd.d80b9cc1-55f5-76d5-e053-2995a90aa9672024-12-19WarningsExact identifier
application number: M012
Health Smart Vaporizing Chest RubMENTHOL AND CAMPHOR AND EUCALYPTUS OILHome Smart Productsacab200e-48bd-69e1-e053-2995a90afde02024-12-19WarningsExact identifier
application number: M012
Halls MENTHO-LYPTUSMENTHOLMondelez Global LLCff21cf0e-9811-4819-bdfc-17a950e9b1142024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold, Flu and Sore ThroatACTEAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company7bddce11-c227-4d95-94c1-6f41ecd7285b2024-12-19WarningsExact identifier
application number: M012
Childrens Tussnex Multi-symptom coldDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company9028676e-d725-4afe-aa14-72235825aa172024-12-19WarningsExact identifier
application number: M012
Tussnex FM Cold and SinusACTEAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company04c6bb6a-d2f8-4322-afba-e240e80901762024-12-19WarningsExact identifier
application number: M012
Tussnex FM Severe cough and congestionDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLGuardian Drug Company387df403-7803-4031-915e-8de9b103a1622024-12-19WarningsExact identifier
application number: M012
Maximum strength Tussnex FM DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINGuardian Drug Company0bae53e3-9661-4bc6-9fcc-da7fa131b0342024-12-19WarningsExact identifier
application number: M012
Vicks Vaposteam LavenderCAMPHOR, (-)-Kaz USA, Inc03bf6b78-cf8e-44c6-bae0-5bd0a85f8aa92024-12-19WarningsExact identifier
application number: M012
Refenesen Mucus Relief DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINReese Pharmaceutical Co6046dc50-f162-4e2d-aa3c-7d27efad477d2024-12-18WarningsExact identifier
application number: M012
Sunmark Chest Congestion Relief PE PEGUAIFENESIN/PHENYLEPHRINEStrategic Sourcing Services LLCf94ae469-4c79-4ce9-9a3d-3bdc645be6d92024-12-18WarningsExact identifier
application number: M012
Quality Choice Mucus Relief DM DMDEXTROMETHORPHAN HYDROBROMIDE / GUAIFENESINChain Drug Marketing Association1c33a01f-1186-4a19-b639-a9cd492452202024-12-18WarningsExact identifier
application number: M012
HealthMart Chest Congestion ReliefGUAIFENESINStrategic Sourcing Services LLCa5d1a8e8-10ba-4fff-b6f7-18c0fde5155c2024-12-18WarningsExact identifier
application number: M012
DG Health Immediate Release Mucus ReliefGUAIFENESINReese Pharmaceutical Cof60a9d1b-7a63-43d3-b843-e1f31cf788732024-12-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166123dextromethorphan Hbr 10 MG / guaiFENesin 200 MG / phenylephrine HCl 5 MG in 15 mL Oral SolutionPSNc48359ee-6e52-841d-e053-2a95a90ae2939
2166123dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML / phenylephrine hydrochloride 0.333 MG/ML Oral SolutionSCDc48359ee-6e52-841d-e053-2a95a90ae2939
2166123dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / phenylephrine hydrochloride 5 MG per 15 ML Oral SolutionSYc48359ee-6e52-841d-e053-2a95a90ae2939

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-922-1269423092212354 mL in 1 BOTTLE, PLASTIC (69423-922-12) 354 ml2021-01-010000-00-00NoNoCurrent