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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1086997Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ff0a4054-0745-f649-e053-6394a90af904Available on FDA.report

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 19 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Kids Pain and FeverACETAMINOPHENCalmCo LLC2ee6df99-727a-34c6-e063-6294a90a6bbc2026-07-06WarningsExact identifier
application number: M012
Dr Kids Allergy ReliefDIPHENHYDRAMINE HCLCalmCo LLC28ec213e-fabb-28ec-e063-6394a90ad1022026-07-06WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRSelect Consumer Group55fc7d6f-cc44-b4c0-e063-6294a90ae4fc2026-07-06WarningsExact identifier
application number: M012
Allergy Plus Sinus HeadacheACETAMINOPHEN, DIPHENHYDRAMINE HCL AND PHENYLEPHRINE HCLDOLGENCORP, LLCf2eacb1b-8b29-41ec-828a-c1f902ac09342026-07-06WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDESelect Consumer Group55d10292-e673-9896-e063-6294a90a56742026-07-04WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDESelect Consumer Group55bddbea-5ad9-6a18-e063-6394a90a461d2026-07-03WarningsExact identifier
application number: M012
CONTAC COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE AND DOXYLAMINE SUCCINATEVESPYR BRANDS LLCf72d510b-e370-4137-8d4f-d9afd5d19a192026-07-03WarningsExact identifier
application number: M012
Nite time Severe Cold and Flu Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Incf8f84be1-e3b1-4e93-8e1c-ee93e1f4af132026-07-02WarningsExact identifier
application number: M012
COUGH AND CHEST CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.9d355bf8-6398-4f3a-902a-c41cf5840c152026-07-02WarningsExact identifier
application number: M012
TUSSIN CF SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC01d6c897-619d-4a6d-8950-4d6d32346b9b2026-07-01WarningsExact identifier
application number: M012
NITE TIME INTENSE FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.161c34b4-3cd2-40b4-b13e-ad980ad4249c2026-07-01WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)437cd589-f5da-4390-b178-609d4537eaab2026-07-01WarningsExact identifier
application number: M012
Cold and Flu Nighttime SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLL.N.K. International, Inc.9167a80e-fcf0-4b64-97e6-8a8ac566f1342026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS CHERRYDISCOUNT DRUG MART55653790-9400-e63b-e063-6394a90ae5f72026-06-29WarningsExact identifier
application number: M012
DISCOUNT DRUG MARTCOUGH DROPS MENTHOLDISCOUNT DRUG MART55656a74-9721-62cf-e063-6394a90a7eb72026-06-29WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS CHERRYMedical Group Care LLC5565f02b-ce38-339f-e063-6294a90a671c2026-06-29WarningsExact identifier
application number: M012
DAYTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEMeijer, Inc.b3be2068-39e8-45f8-950e-afaee2c2520f2026-06-29WarningsExact identifier
application number: M012
NIGHTTIME COUGH DMDEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED646f65f4-b9e4-4291-aadc-d2070848d35c2026-06-29WarningsExact identifier
application number: M012
Sinus Pressure, Pain and CoughACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLDOLGENCORP, LLC259b6f12-50c0-4e7a-9a44-bdf7e9a20a562026-06-29WarningsExact identifier
application number: M012
Diphenhydramine HydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHealth Pharma USA LLC31755678-825c-b84a-e063-6294a90a5a832026-06-27WarningsExact 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