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
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 163 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Severe Cold and Flu Daytime HoneyACETAMINOPHEN, DEXTROMETHROPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLKroger10b0fa3d-d6b2-272a-e063-6394a90a12052024-05-08WarningsExact identifier
application number: M012
Childrens Plus Multi Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWalgreensdd967cfb-96b4-4cdc-82e2-a4838001c9e32024-05-08WarningsExact identifier
application number: M012
Childrens Wal Tap Elixer Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreens3f438f28-d1ad-44da-a573-f1b0824b051c2024-05-08WarningsExact identifier
application number: M012
Cough Cold and Sore Throat ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens400a0998-e276-4c8d-9b41-145b1b405fff2024-05-08WarningsExact identifier
application number: M012
Mucus Congestion and Cough Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCIWalgreens19cd2409-d56b-4319-833c-eacc7dc498c12024-05-08WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger10b12f0e-dba7-fd71-e063-6294a90a42c12024-05-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATEKroger10b15337-b9c5-4dc8-e063-6394a90ac0562024-05-06WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger1014da86-3a0e-136f-e063-6294a90ac9312024-05-04WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLC09e20842-2b75-43b9-ae5f-3515b35e655b2024-05-03WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)f958d8ba-ede9-4b1a-8317-2404b68a91292024-05-03WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLCfab57d70-ba54-416f-9f14-b64d2238ea162024-05-03WarningsExact identifier
application number: M012
Tussin CF Non Drowsy Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLC8ee27600-4f8e-406a-8ea3-eade691448f62024-05-03WarningsExact identifier
application number: M012
SanaTos Children Cough and Congestion CherryDEXTROMETHORPHAN HBR AND GUAIFENESINPharmadel LLC60437d86-9e13-8d8a-e053-2991aa0a23172024-05-02WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC0b41da13-18a1-4987-ae43-1319bfa274842024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)dbfb8971-a122-4a97-a665-e3f0d494876e2024-05-01WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLCc08b150c-d821-466c-8521-f77535d6af1e2024-04-30WarningsExact identifier
application number: M012
childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Company7848bb09-2af8-47f6-b32d-96635a750a552024-04-29WarningsExact 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