FDA.reportPublic FDA data

Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM

Product NDC
58933-550
11-digit product format
589330550
Labeler code
58933
Product ID
58933-550_48824b85-d831-1ada-e063-6294a90a3793
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan HBr, Phenylephrine HCl
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-03-22
Marketing end
2027-06-30
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
500; 10; 20 mg/5g; mg/5g; mg/5g
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
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 HOT REMEDY RAPID RELIEF MULTI-SYMPTOM
Brand name suffix
Cold and Flu plus Congestion

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN500 mg/5g
PHENYLEPHRINE HYDROCHLORIDE10 mg/5g
DEXTROMETHORPHAN HYDROBROMIDE20 mg/5g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
04JA59TNSJInternal 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
1189316Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f77226c0-b6d5-9fd0-e053-6294a90a4b57Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-550-01Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION5 g500 mg in 5g12
58933-550-01Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION59
58933-550-08Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion8 in 1 PACKAGEPOWDER, FOR SOLUTION89
58933-550-08Vicks DayQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION59

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-550VICKS DAYQUIL NYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) KIT [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]10Current NDC20250223_f691734b-5cf4-6eb8-e053-2a95a90aee80.zip
58933-550VICKS DAYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]7Current NDC, 3 package rows20241012_f77226c0-b6d5-9fd0-e053-6294a90a4b57.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 37 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ALKA SELTZER COLD Cold and Flu Severe Day Night Fast DissolveASPIRIN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.50762d7c-5efd-4f83-e063-6294a90abf7f2026-04-27WarningsExact identifier
application number: M012
Cold and Flu Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEL.N.K. International, Inc.6427b418-89d1-4eac-b25b-0adfefc204fc2026-04-27WarningsExact identifier
application number: M012
Nighttime Sleep AidDIPHENHYDRAMINE HCLCare One (American Sales Company)bd5de3b3-7cb5-4403-b664-23ac70b9957f2026-04-27WarningsExact identifier
application number: M012
Leader Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLCardinal Health 110, LLC. dba Leader333c7042-95b8-4d98-9df1-4287017afa362026-04-25WarningsExact identifier
application number: M012
foster and thrive nasalOXYMETAZOLINE HYDROCHLORIDESportpharm LLCf2d55d1b-c3d4-4c35-b761-681ed50273bd2026-04-24WarningsExact identifier
application number: M012
Geri-Dryl allergy reliefDIPHENHYDRAMINE HCLSportpharm LLC2c4e0d5e-958d-4274-876a-52126c795c0f2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Headache Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.50364a42-3333-51fe-e063-6394a90ab71e2026-04-24WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Flu Severe Fast DissolveCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5036dc50-e95b-ea8d-e063-6394a90a6cfe2026-04-24WarningsExact identifier
application number: M012
Cold and Flu Daytime NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDdcb33d5f-87fa-4043-9b6d-36adec96796c2026-04-24WarningsExact identifier
application number: M012
Diphenhydramine HClDIPHENHYDRAMINE HCLCardinal Health 107, LLCabc0e348-8532-4658-bd8c-d7dbe5a28c7d2026-04-23WarningsExact identifier
application number: M012
nitetime severeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEPublix Super Markets Incc5535aaf-c029-48d8-97d1-105a49b5fd952026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Cough Maximum Strength Fast DissolveASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer Healthcare LLC.50228b3c-d54a-485d-e063-6394a90a44032026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Flu Severe Fast ChewablesCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.5025a333-6378-bf59-e063-6394a90af4f02026-04-23WarningsExact identifier
application number: M012
POLY-HIST DMDEXCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HBRPOLY PHARMACEUTICALS, INC.5025c99f-b946-e2e0-e063-6394a90a13fb2026-04-23WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold and Allergy Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE , DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.5026611c-93e7-8f90-e063-6394a90a7baa2026-04-23WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLDOLGENCORP, LLCc9c1db0f-6ba4-433c-b0ce-e99e9351c0b02026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Plus CongestionACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLCOSTCO WHOLESALE CORPORATION5180abbc-c6c4-4b82-b6e7-4504e3bcff0f2026-04-23WarningsExact identifier
application number: M012
Severe Cold and Flu Night timeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLHyVee Inc4f963491-e1f0-494d-acb6-5f4d2b267d4a2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE MOISTURIZING ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbHf4b01827-7444-3bfc-e053-2a95a90aebed2026-04-22WarningsExact identifier
application number: M012
Vicks Sinex SEVERE ORIGINAL ULTRA FINE MISTOXYMETAZOLINE HYDROCHLORIDEProcter & Gamble Manufacturing GmbH,cfd43b8f-8064-6b88-e053-2a95a90a329e2026-04-22WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2640034{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral Solution) } PackGPCKf691734b-5cf4-6eb8-e053-2a95a90aee8012
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackPSNf691734b-5cf4-6eb8-e053-2a95a90aee8012
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNf691734b-5cf4-6eb8-e053-2a95a90aee8012
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNf691734b-5cf4-6eb8-e053-2a95a90aee8012
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDf691734b-5cf4-6eb8-e053-2a95a90aee8012
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDf691734b-5cf4-6eb8-e053-2a95a90aee8012
26400341 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral Solution) PackSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYf691734b-5cf4-6eb8-e053-2a95a90aee8012
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNf77226c0-b6d5-9fd0-e053-6294a90a4b579
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDf77226c0-b6d5-9fd0-e053-6294a90a4b579
1189316acetaminophen 500 MG / dextromethorphan HBr 20 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYf77226c0-b6d5-9fd0-e053-6294a90a4b579
1189316acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYf77226c0-b6d5-9fd0-e053-6294a90a4b579
1189316APAP 500 MG / Dextromethorphan Hydrobromide 20 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYf77226c0-b6d5-9fd0-e053-6294a90a4b579

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-550-01589330550015 g in 1 PACKET (58933-550-01) 5 g2023-03-222027-06-30NoNoHistorical
58933-550-08589330550088 PACKET in 1 PACKAGE (58933-550-08) / 5 g in 1 PACKET8 packet2023-03-222027-06-30NoNoHistorical