Vicks NyQuil

Product NDC
69423-995
11-digit product format
694230995
Labeler code
69423
Product ID
69423-995_5d1b1356-ec59-a707-e063-6394a90a3604
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, and Doxylamine Succinate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-01-01
Substance
DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE; ACETAMINOPHEN
Active strength
15; 6.25; 325 mg/1; mg/1; mg/1
Pharmacologic classes
Antihistamine [EPC], Histamine Receptor Antagonists [MoA], 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
Brand name suffix
COLD and FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1
ACETAMINOPHEN325 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-995-02Vicks NyQuilCOLD and FLU2 in 1 POUCHCAPSULE, LIQUID FILLED212
69423-995-08Vicks NyQuilCOLD and FLU4 in 1 CARTONCAPSULE, LIQUID FILLED412
69423-995-08Vicks NyQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED212
69423-995-16Vicks NyQuilCOLD and FLU8 in 1 CARTONCAPSULE, LIQUID FILLED812
69423-995-16Vicks NyQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED212
69423-995-24Vicks NyQuilCOLD and FLU8 in 1 CARTONCAPSULE, LIQUID FILLED812
69423-995-24Vicks NyQuilCOLD and FLU3 in 1 BLISTER PACKCAPSULE, LIQUID FILLED312
69423-995-48Vicks NyQuilCOLD and FLU2 in 1 BLISTER PACKCAPSULE, LIQUID FILLED212
69423-995-48Vicks NyQuilCOLD and FLU24 in 1 CARTONCAPSULE, LIQUID FILLED2412

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-995VICKS NYQUIL COLD AND FLU (ACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND DOXYLAMINE SUCCINATE) CAPSULE, LIQUID FILLED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]9Current NDC, Legacy NDC, 9 package rows20241012_efe4e649-7514-32dd-e053-2995a90a0492.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 131 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin Multi Symptom Cold CFDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINEBest Choice (Valu Merchandisers Company)539b8972-2a46-468e-ad27-6672d746feb72024-12-10WarningsExact identifier
application number: M012
DUAL ACTION GLACIER MINT COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola USA Inc.db2ab9be-507d-4768-9d00-188f751b77262024-12-10WarningsExact identifier
application number: M012
Adult Allergy ReliefCALMCO ALLERGY RELIEFCalmCo08288825-0f38-b6a3-e063-6394a90aa3582024-12-07WarningsExact identifier
application number: M012
Original Herb Cough DropsMENTHOLRicola Agc142663f-086e-4ab7-a758-9107d70775372024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag984c9793-163c-4b97-b244-9b471966a1222024-12-05WarningsExact identifier
application number: M012
BENZEDREXPROPYLHEXEDRINEBF ASCHER AND CO INC00d8c237-3eee-1d9f-e063-6394a90aeb862024-12-05WarningsExact identifier
application number: M012
Cold Multi Symptom Daytime NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDEChain Drug Marketing Associationd5cbb5b0-564c-429e-b680-fa683e7963932024-12-05WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCarede8a623f-7b10-4d56-a74b-3737e7716ffe2024-12-05WarningsExact identifier
application number: M012
Cold Max DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC9773958b-c5e5-4da7-a8e9-6b6c223a2b302024-12-05WarningsExact identifier
application number: M012
Cold Plus Head Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND PHENYLEPHRINE HYDROCHLORIDETopCo Associates LLC399e0e51-c2a7-451c-b74d-d3db140cef692024-12-05WarningsExact identifier
application number: M012
Head Congestion Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI09531edc-8dbd-451f-ae02-f922e9e8c2482024-12-05WarningsExact identifier
application number: M012
DUAL ACTION CHERRY COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag71ca8af7-172d-40da-be1e-ff3ab5568e742024-12-05WarningsExact identifier
application number: M012
SUGAR FREE ORIGINAL SWISS HERB COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Agb790a91c-33be-4bc3-bdeb-eae6f366f0852024-12-05WarningsExact identifier
application number: M012
EXTRA STRENGTH WITH NATURAL MENTHOL GLACIER MINT COUGH SUPPRESSANTMENTHOLRicola Agea42e516-2ef8-41c9-ae4e-571f0147bc6b2024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE SWISS CHERRYMENTHOLRicola Ag8b2d5c0f-509e-447d-b071-d73c4785f1202024-12-05WarningsExact identifier
application number: M012
SUGAR FREE GREEN TEA WITH ECHINACEA COUGH SUPPRESSANT THROAT DROPSMENTHOLRicola Ag8ae0e21a-44a0-4a2c-9880-54eeeaea07ea2024-12-05WarningsExact identifier
application number: M012
MOUNTAIN HERB SUGAR FREE WITH STEVIA COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Ag6d82469b-d51c-4824-9830-6c1874ad4fe42024-12-05WarningsExact identifier
application number: M012
RICOLA MAX THROAT CARE COOL PEPPERMINTMENTHOLRicola Age8bedf6f-4a2e-4a76-ba8c-bdb249fb6ce52024-12-05WarningsExact identifier
application number: M012
DUAL ACTION HONEY LEMON COUGH SUPPRESSANT ORAL ANESTHETICMENTHOLRicola Aga535717d-ba55-45e9-9fc3-711b5d7dbf572024-12-05WarningsExact identifier
application number: M012
THE ORIGINAL NATURAL HERB COUGH DROPSMENTHOLRicola Ag4330ee8d-0b37-4a93-886b-5fc6e6598da72024-12-05WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNefe4e649-7514-32dd-e053-2995a90a049212
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDefe4e649-7514-32dd-e053-2995a90a049212
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYefe4e649-7514-32dd-e053-2995a90a049212
2634564{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral Capsule) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral Capsule) } PackGPCKefb92829-1007-1c5d-e053-2a95a90a3c9b8
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackPSNefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral CapsulePSNefb92829-1007-1c5d-e053-2a95a90a3c9b8
1094549acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral CapsulePSNefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSCDefb92829-1007-1c5d-e053-2a95a90a3c9b8
1094549acetaminophen 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSCDefb92829-1007-1c5d-e053-2a95a90a3c9b8
26345641 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / phenylephrine HCl 5 MG Oral Capsule) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG Oral Capsule) PackSYefb92829-1007-1c5d-e053-2a95a90a3c9b8
1086997APAP 325 MG / dextromethorphan hydrobromide 10 MG / phenylephrine hydrochloride 5 MG Oral CapsuleSYefb92829-1007-1c5d-e053-2a95a90a3c9b8
1094549APAP 325 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG Oral CapsuleSYefb92829-1007-1c5d-e053-2a95a90a3c9b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69423-995-02694230995022 CAPSULE, LIQUID FILLED in 1 POUCH (69423-995-02) 2021-01-010000-00-00NoNoCurrent
69423-995-08694230995084 BLISTER PACK in 1 CARTON (69423-995-08) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK4 blister pack2021-01-010000-00-00NoNoCurrent
69423-995-16694230995168 BLISTER PACK in 1 CARTON (69423-995-16) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2021-01-010000-00-00NoNoCurrent
69423-995-24694230995248 BLISTER PACK in 1 CARTON (69423-995-24) / 3 CAPSULE, LIQUID FILLED in 1 BLISTER PACK8 blister pack2021-01-01NoNoCurrent
69423-995-486942309954824 BLISTER PACK in 1 CARTON (69423-995-48) / 2 CAPSULE, LIQUID FILLED in 1 BLISTER PACK24 blister pack2021-01-010000-00-00NoNoCurrent