FDA.reportPublic FDA data

Vicks NyQuil Alcohol Free

Product NDC
69423-899
11-digit product format
694230899
Labeler code
69423
Product ID
69423-899_5d18d9ea-6f08-6642-e063-6294a90a97a7
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Chlorpheniramine maleate, and Dextromethorphan Hydrobromide
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-20
Substance
ACETAMINOPHEN; CHLORPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
650; 4; 30 mg/30mL; mg/30mL; mg/30mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], Sigma-1 Agonist [EPC], Sigma-1 Receptor Agonists [MoA], Uncompetitive N-methyl-D-aspartate Receptor Antagonist [EPC], Uncompetitive NMDA Receptor Antagonists [MoA]
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 NyQuil Alcohol Free
Brand name suffix
Cold and Flu Nighttime Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/30mL
CHLORPHENIRAMINE MALEATE4 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d17a97fa-387f-690e-d2be-0083ab044a03Product name320170725
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
c6fba691-a132-4ede-95c6-f8c6bd696636Product name120150902
c0200ab5-4954-454e-9676-30b741b245bdProduct name120150730

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69423-899-122024-01-30C16284748780-11030e365-2116-111a-e063-dadaa90a10e2VICKS ® NyQuil Alcohol Free COLD & FLU
69423-899-122024-01-30C16284748780-11030e365-2116-111a-e063-dadaa90a10e2VICKS ® NyQuil Alcohol Free COLD & FLU

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-899-12Vicks NyQuil Alcohol FreeCold and Flu Nighttime Relief354 mL in 1 BOTTLE, PLASTICLIQUID3547

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-899VICKS NYQUIL ALCOHOL FREE COLD AND FLU NIGHTTIME RELIEF (ACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, AND DEXTROMETHORPHAN HYDROBROMIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]5Current NDC, Legacy NDC, 1 package rows20241012_ec57c15e-cb6d-44a9-e053-2a95a90ae774.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 137 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family Wellness Oxymetazoline Sinus SevereOXYMETAZOLINEFAMILY DOLLAR (Family Wellness)13237d31-c60a-49f8-9b96-4414cf766a082024-11-21WarningsExact identifier
application number: M012
DayTime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.5b55d1df-275b-40d8-bde3-fc43313b7eb32024-11-20WarningsExact identifier
application number: M012
Halls Green AppleMENTHOLMondelez Global LLC1bb8dcb2-c3a8-a64e-e063-6294a90ae4a22024-11-20WarningsExact identifier
application number: M012
Halls BlueberryMENTHOLMondelez Global LLC275a6935-ea44-486e-e063-6394a90ae19a2024-11-20WarningsExact identifier
application number: M012
No Drip Nasal MistOXYMETAZOLINE SPRAYWalgreens Company234bd567-4e3c-419f-a000-fdfc28cafc8b2024-11-20WarningsExact identifier
application number: M012
NICE Assorted Cough DropsMENTHOLLeosons Overseas Corp96db0f37-41cc-1ebd-e053-2a95a90a32152024-11-19WarningsExact identifier
application number: M012
Nice Cherry Cough DropsMENTHOLLeosons Overseas Corp98e52604-6e41-6408-e053-2995a90a6bc82024-11-19WarningsExact identifier
application number: M012
NICE Citrus Cough DropsMENTHOLLeosons Overseas Corp96d9527d-9bf9-ce82-e053-2995a90aff0c2024-11-19WarningsExact identifier
application number: M012
NICE Menthol Cough DropsMENTHOLLeosons Overseas Corp96d77897-475c-482c-e053-2995a90a2da42024-11-19WarningsExact identifier
application number: M012
NICE Honey Lemon Cough DropsMENTHOLLeosons Overseas Corp96da2c9d-2d0d-6252-e053-2995a90ac3382024-11-19WarningsExact identifier
application number: M012
SanaTos BoostDEXTROMETHORPHAN HBRPharmadel LLCae6a424f-f3f0-3f6c-e053-2995a90a972d2024-11-18WarningsExact identifier
application number: M012
SanaTos Turbo Max StrengthDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLPharmadel LLCd56a071c-a747-5397-e053-2995a90aad8b2024-11-18WarningsExact identifier
application number: M012
cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLH E B404ef5f4-7b7b-4c08-b159-9175a91be1322024-11-17WarningsExact identifier
application number: M012
equaline childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIa24021a0-ef68-4bce-ba53-d262d1025cc02024-11-17WarningsExact identifier
application number: M012
Cold and Cough DMBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPublix Super Markets Inc4d5f93c1-7752-4948-ba58-c4385cfc24c82024-11-17WarningsExact identifier
application number: M012
Good Sense Childrens Cold and CoughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company8a87104f-94a4-4585-afd5-d610eea32e392024-11-17WarningsExact identifier
application number: M012
equate childrens cold and coughBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLWal-Mart Stores Incc91e94f4-4c51-4fe7-ad2e-0b9dc58b51e42024-11-17WarningsExact identifier
application number: M012
foster and thrive childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEStrategic Sourcing Services LLC1eac715b-351c-4b47-8d1d-6e921813c1a42024-11-15WarningsExact identifier
application number: M012
basic care daytime severe cold and flu nighttime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEAmazon.com Services LLC298d2796-5ae5-4346-b6d2-2ced2dd29dc32024-11-15WarningsExact identifier
application number: M012
dg health day time severe cold and flu relief night time severe cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEDolgencorp, LLCf721b393-9ad5-4fc6-a2c5-bd89e58caf162024-11-15WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1046384acetaminophen 650 MG / chlorpheniramine maleate 4 MG / dextromethorphan HBr 30 MG in 30 mL Oral SolutionPSNec57c15e-cb6d-44a9-e053-2a95a90ae7747
1046384acetaminophen 21.7 MG/ML / chlorpheniramine maleate 0.133 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCDec57c15e-cb6d-44a9-e053-2a95a90ae7747
1046384acetaminophen 325 MG / chlorpheniramine maleate 2 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSYec57c15e-cb6d-44a9-e053-2a95a90ae7747
1046384acetaminophen 650 MG / chlorpheniramine maleate 4 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSYec57c15e-cb6d-44a9-e053-2a95a90ae7747
1046384APAP 21.7 MG/ML / Chlorpheniramine Maleate 0.133 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSYec57c15e-cb6d-44a9-e053-2a95a90ae7747

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-899-1269423089912354 mL in 1 BOTTLE, PLASTIC (69423-899-12) 354 ml2021-01-200000-00-00NoNoCurrent