FDA.reportPublic FDA data

Vicks DayQuil

Product NDC
69423-800
11-digit product format
694230800
Labeler code
69423
Product ID
69423-800_5d18ed78-3913-83cd-e063-6294a90a58d8
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-06
Substance
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
5; 325; 10 mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], 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
ULTRA CONCENTRATED COLD and FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-800-48Vicks DayQuilULTRA CONCENTRATED COLD and FLU1 in 1 CARTONCAPSULE, LIQUID FILLED111
69423-800-48Vicks DayQuilULTRA CONCENTRATED COLD and FLU48 in 1 BOTTLECAPSULE, LIQUID FILLED4811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-800VICKS DAYQUIL ULTRA CONCENTRATED COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 2 package rows20241012_ff0a4054-0745-f649-e053-6394a90af904.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 113 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Relief Diphenhydramine HCl 25mg SoftGelDIPHENHYDRAMINE HYDROCHLORIDENUVICARE LLCbb728ceb-8eb0-4192-a8b0-742756819a052025-06-26WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDETIME CAP LABORATORIES, INC7aee34b5-1583-4a8a-8ffb-b17ef2722ac12025-06-25WarningsExact identifier
application number: M012
ALLERGY RELIEFDIPHENHYDRAMINE HYDROCHLORIDEWALGREENSc0270298-e7c5-e500-e053-2995a90aed232025-06-25WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEWalmart Inc.24ff91f2-02db-56a2-e063-6394a90a31c92025-06-25WarningsExact identifier
application number: M012
Cough and Chest Congestion Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINGenexa Inc.e920b700-30d3-3266-e053-2a95a90a06392025-06-24WarningsExact identifier
application number: M012
good sense childrens cold coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEL. Perrigo Company2ffe0fbc-236d-417b-bbfd-5b9294f3c90a2025-06-23WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38034ad2-5eab-9caf-e063-6294a90abb8f2025-06-20WarningsExact identifier
application number: M012
Herbal Cough DropsHERBAL MENTHOLMeijer, Inc.380364be-4e52-fa52-e063-6394a90a713c2025-06-20WarningsExact identifier
application number: M012
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE TABLET, COATEDLil' Drug Store Products, Inc.37c55543-e05e-2f7c-e063-6394a90a45342025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.38049d29-f47e-9478-e063-6294a90aa2a42025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.3804a271-9a11-848d-e063-6394a90af87d2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Menthol Sugar FreeMENTHOLArmy & Air Force Exchange Service3805ef07-247d-0df7-e063-6394a90ac45b2025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drop Black Cherry Sugar FreeMENTHOLArmy & Air Force Exchange Service3805f8f5-562f-0ba8-e063-6394a90ac9d92025-06-20WarningsExact identifier
application number: M012
Exchange Select Cough Drops Honey Lemon Sugar-FreeMENTHOLArmy & Air Force Exchange Service3805f90e-bd89-128d-e063-6394a90afa012025-06-20WarningsExact identifier
application number: M012
TARGET Multi Symptom Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRTARGET CORPORATIONaebe3c15-53ef-46ea-af39-8c9b8114595f2025-06-20WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTCbe95332d-a2e0-42e8-bfb3-8850d74990ff2025-06-19WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEMorning Star OTC37e939c6-064b-3548-e063-6294a90a337d2025-06-19WarningsExact identifier
application number: M012
Capron DMDEXTROMETHORPHAN HBR AND PYRILAMINE MALEATECapital Pharmaceutical, LLCcf778c5f-475e-4a86-a87c-2be1e665f5a52025-06-18WarningsExact identifier
application number: M012
Cough OutGUAIFENESINEfficient Laboratories Inc.fe4c3921-8d30-4cd6-ba90-9211b362a38a2025-06-18WarningsExact identifier
application number: M012
Guaifenesin STRAWBERRY-BANANA FLAVORGUAIFENESINInnovida Pharmaeutique Corporation1006906e-d6d7-4f49-92bf-3cb2d2cdbb162025-06-18WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNff0a4054-0745-f649-e053-6394a90af90411
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDff0a4054-0745-f649-e053-6394a90af90411
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYff0a4054-0745-f649-e053-6394a90af90411
1648203{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) } PackGPCKff356128-95ea-0fbe-e053-6294a90adcb88
16482031 daytime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNff356128-95ea-0fbe-e053-6294a90adcb88
1426334acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral CapsulePSNff356128-95ea-0fbe-e053-6294a90adcb88
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNff356128-95ea-0fbe-e053-6294a90adcb88
1426334acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDff356128-95ea-0fbe-e053-6294a90adcb88
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDff356128-95ea-0fbe-e053-6294a90adcb88
16482031 daytime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYff356128-95ea-0fbe-e053-6294a90adcb88
1426334APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral CapsuleSYff356128-95ea-0fbe-e053-6294a90adcb88
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYff356128-95ea-0fbe-e053-6294a90adcb88

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-800-48694230800481 BOTTLE in 1 CARTON (69423-800-48) / 48 CAPSULE, LIQUID FILLED in 1 BOTTLE1 bottle2023-07-06NoNoCurrent