FDA.reportPublic FDA data

Vicks DayQuil

Product NDC
69423-994
11-digit product format
694230994
Labeler code
69423
Product ID
69423-994_5d1b0e68-9bf7-a439-e063-6394a90aea63
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Phenylephrine Hydrochloride
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-01-01
Substance
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
325; 10; 5 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
COLD and FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 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
69423-994-02Vicks DayQuilCOLD and FLU2 in 1 POUCHCAPSULE, LIQUID FILLED27
69423-994-08Vicks DayQuilCOLD and FLU4 in 1 CARTONCAPSULE, LIQUID FILLED47
69423-994-08Vicks DayQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
69423-994-16Vicks DayQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
69423-994-16Vicks DayQuilCOLD and FLU8 in 1 CARTONCAPSULE, LIQUID FILLED87
69423-994-24Vicks DayQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
69423-994-24Vicks DayQuilCOLD and FLU12 in 1 CARTONCAPSULE, LIQUID FILLED127
69423-994-48Vicks DayQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED27
69423-994-48Vicks DayQuilCOLD and FLU24 in 1 CARTONCAPSULE, LIQUID FILLED247

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-994VICKS DAYQUIL COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 9 package rows20241012_efb982d4-93d0-815f-e053-2995a90a82dd.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 36 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Panadol Cold and Flu NightACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3417993d-8e3c-23d6-e063-6394a90a7d502026-04-29WarningsExact identifier
application number: M012
Halls Sugar Free Mountain MentholMENTHOLMondelez Global LLC509f233e-ff01-8927-e063-6394a90a99292026-04-29WarningsExact identifier
application number: M012
Broncomiel AdultsDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEPharmadel LLC509c61d3-ae16-be5c-e063-6294a90a68da2026-04-29WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINTOP CARE (Topco Associates LLC)aa1eb90c-e565-455f-8978-6f2f9e00a8142026-04-29WarningsExact identifier
application number: M012
Tussin Cough and Chest Congestion DM adultDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLCe1280355-da81-489f-9bd2-ffea9a68010c2026-04-29WarningsExact identifier
application number: M012
Mucus Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOPCO ASSOCIATES LLC7b095ec5-9951-4491-9b68-7ac0a7f100532026-04-29WarningsExact identifier
application number: M012
Mucus Relief Severe Congestion and Cough Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLTOP CARE (Topco Associates LLC)98dd0ba6-0109-46b2-92df-11a0309842402026-04-28WarningsExact identifier
application number: M012
Pain, Headache and CongestionACETAMINOPHEN, GUAIFENESINCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED41a77cbb-6a4d-46a4-ab27-c7affa2cc6822026-04-28WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.dd7da15a-4e0b-405f-e053-2995a90a06d22026-04-28WarningsExact identifier
application number: M012
CAREONE CHILDRENS COLD COUGHBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDERetail Business Services, LLC382f7d51-ceb8-4bdf-9bd5-440b50c65cd32026-04-28WarningsExact identifier
application number: M012
Cold and Flu Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.1a520b4f-6a4b-4e37-94c5-9387f2e4c34a2026-04-27WarningsExact identifier
application number: M012
Childrens Multi-Symptom ColdDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKroger49a7cd2a-8c0e-2196-e063-6294a90a134a2026-04-27WarningsExact identifier
application number: M012
Guaifenesin,Dextromethorphan HbrGUAIFENESIN,DEXTROMETHORPHAN HBRSoftgel Healthcare Pvt Ltd3e5d978f-cc70-60a5-e063-6394a90a67d32026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan Hydrobromide, Doxylamine Succinate and Phenylephrine HydrochlorideACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE AND PHENYLEPHRINE HYDROCHLORIDESoftgel Healthcare Pvt Ltd36ced59c-12dc-441f-e063-6294a90a32392026-04-27WarningsExact identifier
application number: M012
Acetaminophen 325mg, Dextromethorphan HBr 10mg and Phenyleprine Hcl 5mgACETAMINOPHEN, DEXTROMETHORPHAN HBR AND PHENYLEPHRINE HCLSoftgel Healthcare Private Limited30ab39f3-27cc-5728-e063-6394a90a9cbe2026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr and Doxylamine SuccinateACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESoftgel Healthcare Private Limited353f71f7-81e0-08c2-e063-6294a90acb492026-04-27WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBr ,GuaifenesinACETAMINOPHEN, DEXTROMETHORPHAN HBR ,GUAIFENESINSoftgel Healthcare Pvt Ltd353ef34f-760d-ae92-e063-6294a90a5b4a2026-04-27WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HYDROCHLORIDEDIPHENHYDRAMINE HYDROCHLORIDESOFTGEL HEALTHCARE PRIVATE LIMITED0203d919-dc1f-cca0-e063-6394a90aa1aa2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu and Congestion Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.507214ad-1e06-fe21-e063-6294a90a59cd2026-04-27WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Congestion Severe Day Night Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50738a43-7299-270c-e063-6294a90af2cc2026-04-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKefb92829-1007-1c5d-e053-2a95a90a3c9b8
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNefb92829-1007-1c5d-e053-2a95a90a3c9b8
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDefb92829-1007-1c5d-e053-2a95a90a3c9b8
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDefb92829-1007-1c5d-e053-2a95a90a3c9b8
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYefb92829-1007-1c5d-e053-2a95a90a3c9b8
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNefb982d4-93d0-815f-e053-2995a90a82dd7
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDefb982d4-93d0-815f-e053-2995a90a82dd7
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYefb982d4-93d0-815f-e053-2995a90a82dd7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-994-02694230994022 CAPSULE, LIQUID FILLED in 1 POUCH (69423-994-02) 2020-01-010000-00-00NoNoCurrent
69423-994-08694230994084 BLISTER PACK in 1 CARTON (69423-994-08) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2020-01-010000-00-00NoNoCurrent
69423-994-16694230994168 BLISTER PACK in 1 CARTON (69423-994-16) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2020-01-010000-00-00NoNoCurrent
69423-994-246942309942412 BLISTER PACK in 1 CARTON (69423-994-24) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK12 blister pack2020-01-010000-00-00NoNoCurrent
69423-994-486942309944824 BLISTER PACK in 1 CARTON (69423-994-48) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2020-01-010000-00-00NoNoCurrent