FDA.reportPublic FDA data

Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM

Product NDC
58933-551
11-digit product format
589330551
Labeler code
58933
Product ID
58933-551_48832f07-1ccc-77f8-e063-6394a90a9ff4
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl, 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
PHENYLEPHRINE HYDROCHLORIDE; ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
10; 650; 25 mg/5g; mg/5g; mg/5g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], 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 NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOM
Brand name suffix
Cold and Flu plus Congestion

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE10 mg/5g
ACETAMINOPHEN650 mg/5g
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/5g

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
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1659960Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f771aa19-295a-9f4e-e053-6294a90a1674Available 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

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
58933-551-01Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU PLUS CONGESTION
58933-551-01Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU PLUS CONGESTION
58933-551-08Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU PLUS CONGESTION
58933-551-08Vicks® NyQuil™ HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD & FLU PLUS CONGESTION

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-551-01Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION515
58933-551-08Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION515
58933-551-08Vicks NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion8 in 1 PACKAGEPOWDER, FOR SOLUTION815
58933-551-01Vicks DayQuil NyQuil HOT REMEDY RAPID RELIEF MULTI-SYMPTOMCold and Flu plus Congestion5 g in 1 PACKETPOWDER, FOR SOLUTION5 g650 mg in 5g12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-551VICKS NYQUIL HOT REMEDY RAPID RELIEF MULTI-SYMPTOM COLD AND FLU PLUS CONGESTION (ACETAMINOPHEN, DIPHENHYDRAMINE HCL, PHENYLEPHRINE HCL) POWDER, FOR SOLUTION [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]13Current NDC, 3 package rows20241012_f771aa19-295a-9f4e-e053-6294a90a1674.zip
58933-551VICKS 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

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 41 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr. Simi Nighttime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MGFarmacias De Similares TX LLC4e5772ee-586c-6191-e063-6294a90a132d2026-03-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HCLHyVee Inc75b19163-db1c-42fc-8bbb-364be16b9b2f2026-03-30WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Inca9f23c63-eeda-4de9-aec6-fe482f469e982026-03-27WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCHAIN DRUG MARKETING ASSOCIATION INC7d1b3418-85a8-4ca0-bca7-261b2b58032a2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH COLD, FLU AND SORE THROATACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDECVS Pharmacy, Inc.bfc38500-5706-0d03-e053-2995a90a5c722026-03-26WarningsExact identifier
application number: M012
NIGHTTIME SEVERE COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS HEALTH CORP2baa0861-dbef-7910-e063-6394a90a117e2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME SINUS RELIEFACETAMINOPHEN DEXTROMETHORPHAN HBR GUAIFENESIN PHENYLEPHRINE HCL AND ACETAMINOPHEN DEXTROMETHORPHAN HBR DOXYLAMINE SUCCINATE PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17d5ba7-3302-7931-e053-2a95a90a5a6c2026-03-26WarningsExact identifier
application number: M012
MAXIMUM STRENGTH DAYTIME NIGHTTIME COLD AND FLUACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCL ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLCVS Pharmacy, Inc.c17b8f17-95f6-37e4-e053-2995a90a411a2026-03-26WarningsExact identifier
application number: M012
Ultra concentrated Daytime/ Nighttime Severe SoftgelACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDE SOFTGELCVS PHARMACY, INC24cedaec-06a6-8fde-e063-6394a90a3d7a2026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS HONEY SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.23079537-1c06-1373-e063-6394a90a37d22026-03-26WarningsExact identifier
application number: M012
MGC HealthCOUGH DROPS MENTHOL SUGAR-FREEXiamen Kang Zhongyuan Biotechnology Co., Ltd.29f2fa8c-071f-50ab-e063-6394a90a4a4a2026-03-26WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength Daytime Nighttime Value PackACETAMINOPHEN, DEXTROMETHORPHAN HBR, AND ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC3618ccf0-1f30-42e0-bb50-bfa45cf2b5832026-03-26WarningsExact identifier
application number: M012
Vicks childrens Cough Congestion NightPHENYLEPHRINE HYDROCHLORIDE AND DIPHENHYDRAMINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Company87231460-8b45-b995-e053-2a91aa0a6c432026-03-26WarningsExact identifier
application number: M012
VICKS CHILDRENS COUGH CONGESTIONDEXTROMETHORPHAN HYDROBROMIDE, DIPHENHYDRAMINE HCL, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEThe Procter & Gamble Manufacturing Companyf1d67797-c806-261d-e053-2a95a90a3c152026-03-26WarningsExact identifier
application number: M012
childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEHyVee Inc686f43ea-4296-4eee-b762-9a9e683443402026-03-26WarningsExact identifier
application number: M012
Tussin DM NighttimeDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED59d3a486-97c2-4e60-90e2-1b5bfa7638c72026-03-26WarningsExact identifier
application number: M012
flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRMeijer Distribution Inc1a853e47-21a2-40e1-9e64-290af4843b132026-03-25WarningsExact identifier
application number: M012
cold fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHyVee Incc4dcc427-aeec-4a26-80f3-02a4b227a5202026-03-25WarningsExact identifier
application number: M012
Walgreens Lavender Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company327a1a00-852d-2756-e063-6394a90a5e292026-03-25WarningsExact identifier
application number: M012
Walgreens Chest RubCAMPHOR, EUCALYPTUS OIL, MENTHOLWalgreen Company2d56ddcd-3cc8-51eb-e063-6394a90ae7452026-03-25WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1659960acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG / phenylephrine HCl 10 MG Granules for Oral SolutionPSNf771aa19-295a-9f4e-e053-6294a90a167415
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Granules for Oral SolutionSCDf771aa19-295a-9f4e-e053-6294a90a167415
1659960acetaminophen 650 MG / diphenhydramine HCl 25 MG / phenylephrine HCl 10 MG Packet for Oral SolutionSYf771aa19-295a-9f4e-e053-6294a90a167415
1659960acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG / phenylephrine hydrochloride 10 MG Powder for Oral SolutionSYf771aa19-295a-9f4e-e053-6294a90a167415
1659960APAP 650 MG / Diphenhydramine Hydrochloride 25 MG / Phenylephrine Hydrochloride 10 MG Granules for Oral SolutionSYf771aa19-295a-9f4e-e053-6294a90a167415
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

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-551-01589330551015 g in 1 PACKET (58933-551-01) 5 g2023-03-222027-06-30NoNoHistorical
58933-551-08589330551088 PACKET in 1 PACKAGE (58933-551-08) / 5 g in 1 PACKET8 packet2023-03-222027-06-30NoNoHistorical