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 35 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Allergy Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)047102c4-3d03-4b2d-961d-0ac75980147b2026-05-06WarningsExact identifier
application number: M012
GOOD SENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEL. Perrigo Companyd25f2649-4f8a-4339-8443-faa0b98bdd702026-05-06WarningsExact identifier
application number: M012
Allergy Relief 4 HourCHLORPHENIRAMINE MALEATEWinCo Foods, LLC27e911e1-6d22-4a50-8413-1809c8973cbd2026-05-06WarningsExact identifier
application number: M012
ALKA SELTZER COLD Cold Cough Maximum Strength Fast GelsACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEBayer HealthCare LLC.51173330-d537-fb9c-e063-6394a90ae3422026-05-05WarningsExact identifier
application number: M012
Equate daytime severe vaporice cold and flu nighttime severe vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATEWal-Mart Stores Inc08e74a8d-8e8d-4cda-9adc-ea2ff40683532026-05-05WarningsExact identifier
application number: M012
GOODSENSE COMBO PACK DAYTIME AND NIGHTTIMEACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, GUAIFENESIN, PHENYLEPHRINE HCLL. Perrigo Companye42f9e0d-f990-4c33-af43-75acf5d776382026-05-05WarningsExact identifier
application number: M012
Rugby Mucus and Chest Congestion 541GUAIFENESINRugby Laboratories76472912-b66f-4bb4-937a-4a589683a78c2026-05-04WarningsExact identifier
application number: M012
Sinus Congestion and Pain Daytime Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDEH E Be9dd2d7b-0a19-4a42-b51e-b9914f02406e2026-05-04WarningsExact identifier
application number: M012
Sanatos NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC3dd3ed85-0c0a-8390-e063-6294a90a668e2026-05-04WarningsExact identifier
application number: M012
Good Sense Daytime non drowsy cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL. Perrigo Company0122cd34-5817-4af5-a51a-8d176dee0a302026-05-04WarningsExact identifier
application number: M012
COLD AND FLU RELIEFACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLSafewayd810a6a9-6112-4e9d-a396-36084b7e110e2026-05-04WarningsExact identifier
application number: M012
Benadryl Allergy UltratabDIPHENHYDRAMINE HYDROCHLORIDESavings Distributors LLC8d59d121-62a8-c43b-e053-2a95a90a58472026-05-01WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8e87f8de-f83e-0f8d-e053-2a95a90a8d6a2026-05-01WarningsExact identifier
application number: M012
Tylenol Sinus SevereACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDESavings Distributors LLC8eecb3f0-eb5e-e847-e053-2995a90a86bd2026-05-01WarningsExact identifier
application number: M012
Sinus Pressure and Congestion Relief PE Maximum StrengthPHENYLEPHRINE HCLRite Aid Corporationfccea3c5-42af-4939-82bc-d9409b75f91f2026-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu originalACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLCcfaf4b3d-fab4-424d-adbe-aaedca58912d2026-04-30WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEHarris Teeter, LLC21e7d323-5b78-43aa-b0fc-34c2a864ab9a2026-04-30WarningsExact identifier
application number: M012
daytime severe cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLH E Bec0b5f4b-b58c-445f-acf1-c7ce301bba642026-04-30WarningsExact identifier
application number: M012
Mucus Relief DM Max Maximum StrengthDEXTROMETHORPHAN HBR, GUAIFENESINHarris Teeter, LLC098428ae-e87d-4c29-8f02-1590530da58e2026-04-29WarningsExact identifier
application number: M012
Panadol Cold and Flu DayACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC341761b9-f0be-f816-e063-6394a90a5e632026-04-29WarningsExact 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