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 122 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Menthol Cough DropsMENTHOLTarget Corporation Inc.eb4c2c3f-91d7-e4c6-e053-2a95a90a4e8a2025-01-26WarningsExact identifier
application number: M012
Walgreens Menthol Cough DropsMENTHOLWalgreens2c62f690-8dfb-d28e-e063-6394a90a45a22025-01-23WarningsExact identifier
application number: M012
Walgreens Cherry Cough DropsMENTHOLWalgreens2c65d836-e724-50d6-e063-6394a90a08272025-01-23WarningsExact identifier
application number: M012
Walgreens Honey Lemon Cough DropsMENTHOLWalgreens2c67424c-2fb0-cc15-e063-6394a90a02ca2025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Analgesic GelMENTHOLAmerican Consumer Products Corp6f0725f2-833f-f3a0-e053-2a91aa0a39112025-01-23WarningsExact identifier
application number: M012
Pharmacys Prescription Vapor RubMENTHOLAmerican Consumer Products Corp6ef328ff-f5c3-515d-e053-2a91aa0a32d32025-01-23WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLBest Choice0035e6a4-b3ef-4e0b-aa7f-7453dd065f4d2025-01-22WarningsExact identifier
application number: M012
GOOD REMEDIES Allergy Relief SOFTGELDIPHENHYDRAMINE HYDROCHLORIDEStrive Pharmaceuticals Inc.26a02737-2cfd-769f-e063-6394a90af3522025-01-22WarningsExact identifier
application number: M012
PharbechlorCHLORPHENIRAMINE MALEATE 4MGUlai Health LLC6a1a5cef-e946-4ba8-9402-557c6adf45f92025-01-20WarningsExact identifier
application number: M012
PharbinexGUAIFENESIN 400MGUlai Health LLC4eafa81a-aeee-4c97-85d6-594902b109192025-01-20Exact identifier
application number: M012
Pharbinex-PEGUAIFENESIN 400MG AND PHENYLEPHRINE HCL 10MGUlai Health LLCe459bb83-b1d6-42fc-aa46-99ad117e61442025-01-20Exact identifier
application number: M012
Pharbinex-DMGUAIFENESIN 400MG AND DEXTROMETHORPHAN HBR 20MGUlai Health LLCaf80d10e-3fb2-405a-a803-1f876b8dcd102025-01-20Exact identifier
application number: M012
Alka-Seltzer Plus Multi-Symptom Cold and Flu Day and Night Liquid GelsACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLBayer HealthCare LLC.34b2e77f-5d04-15a7-e054-00144ff8d46c2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold PowerFast Fizz Orange ZestASPIRIN, CHLORPHENIRAMINE MALEATE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.a23a6db6-4585-2882-e053-2a95a90ab01a2025-01-17WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold Night PowerFast FizzASPIRIN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE BITARTRATEBayer HealthCare LLC.fc754dff-cecd-fc6b-e053-6394a90ab3712025-01-17WarningsExact identifier
application number: M012
Kroger DayTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEThe Kroger Co.2499210b-c162-76b9-e063-6294a90adbc32025-01-17WarningsExact identifier
application number: M012
Childrens Multi Symptom Cold Very BerryDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLCVS2a849ae9-338f-4642-e063-6394a90a1ca42025-01-17WarningsExact identifier
application number: M012
Kroger NightTime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEThe Kroger Co.24a73de3-e9eb-4cd4-e063-6394a90aa2632025-01-17WarningsExact identifier
application number: M012
Diphenhydramine HCl Oral SolutionDIPHENHYDRAMINE HCL ORALEverpharm LLCd7aaf874-69ac-49cf-93be-6d4a38b9a5572025-01-16WarningsExact identifier
application number: M012
Cough ReliefDEXTROMETHORPHAN HBRBest Choice (Valu Merchandisers Company)204a7fc4-142d-45fd-8a77-0612857132be2025-01-16WarningsExact 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