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 81 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Basic Care Honey Lemon Cough DropsMENTHOLAmazon.comc0937b13-f679-a764-e053-2a95a90abf892025-12-05WarningsExact identifier
application number: M012
Basic Care SF Menthol Cough DropsMENTHOLAmazon.comc0946295-7cf0-1bd8-e053-2a95a90af5af2025-12-05WarningsExact identifier
application number: M012
Basic Care SF Honey Lemon Cough DropsMENTHOLAmazon.comcf82fb0b-1b4d-def1-e053-2995a90a6fd92025-12-05WarningsExact identifier
application number: M012
G-DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis7a4e1d64-2510-405f-a1dc-e02a803b6fbd2025-12-05WarningsExact identifier
application number: M012
Quality Choice Severe Cold and Cough NighttimeACETAMINOPHEN, DIPHENHYDRAMINE, PHENYLEPHRINEChain Drug Manufacturing Assnce658dd5-b683-436e-b16b-0c06f6f87fd92025-12-04WarningsExact identifier
application number: M012
Quality Choice Maximum StrengthOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa87ba15f-b5a9-4983-a721-ca7f705aea862025-12-04WarningsExact identifier
application number: M012
Quality ChoicePHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONa12e2e66-d2f3-47a6-a915-a309ae828d272025-12-04WarningsExact identifier
application number: M012
Childrens Mucus Relief Chest CongestionGUAIFENESINChain Drug Manufacturing Assn034d39c0-9aad-4dff-a158-a041b9f0504f2025-12-04WarningsExact identifier
application number: M012
Quality ChoiceOXYMETAZOLINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATIONd01b8fb6-1ddf-4901-bda6-ae608e94a6a42025-12-04WarningsExact identifier
application number: M012
Childrens Mucus and Cough ReliefGUAIFENESIN AND DEXTROMETHORPHAN HYDROBROMIDEChain Drug Manufacturing Assn06822a28-3f82-471d-8db5-c5981b263a032025-12-04WarningsExact identifier
application number: M012
QUALITY CHOICEPHENYLEPHRINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION14596551-dd82-46b3-8eb8-e69efaea105b2025-12-04WarningsExact identifier
application number: M012
Daytime Cold and Flu Lil Drug Store ProductsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Incfd5c20ed-5520-4db0-bfd4-995f043af2a42025-12-04WarningsExact identifier
application number: M012
Afrin OriginalOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.89c165ba-3ad5-49b5-a5bb-423dc8e15bad2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Powerfast Fizz NightASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a2b30c27-b836-f09f-e053-2995a90ac3832025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast FizzASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.a37c9d9d-52db-23ff-e053-2995a90a8f762025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Cough PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.dd7d8a8c-0f91-5ef1-e053-2a95a90a3c6a2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Cough, Mucus and Congestion Day and Night PowermaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.a68df74d-dd26-3ae9-e053-2995a90a08d62025-12-04WarningsExact identifier
application number: M012
Circle K Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDELil' Drug Store Products, Inc.55662ada-677e-4048-9529-5bca440763162025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Day and Night Cold and FluDEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.b13d5132-cb91-3cf6-e053-2a95a90aa47c2025-12-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Maximum Strength Sinus Congestion and Pain PowerFast FizzCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.bd97e91f-1ae1-379c-e053-2995a90acfdd2025-12-04WarningsExact 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