FDA.reportPublic FDA data

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#

NDC, Related label table
NDCRelated label
69423-995-02VICKS ® NyQuil ® COLD & FLU
69423-995-02VICKS ® NyQuil ® COLD & FLU
69423-995-02VICKS ® NyQuil ® COLD & FLU
69423-995-02VICKS ® NyQuil ® COLD & FLU
69423-995-08VICKS ® NyQuil ® COLD & FLU
69423-995-08VICKS ® NyQuil ® COLD & FLU
69423-995-08VICKS ® NyQuil ® COLD & FLU
69423-995-08VICKS ® NyQuil ® COLD & FLU
69423-995-16VICKS ® NyQuil ® COLD & FLU
69423-995-16VICKS ® NyQuil ® COLD & FLU
69423-995-16VICKS ® NyQuil ® COLD & FLU
69423-995-16VICKS ® NyQuil ® COLD & FLU
69423-995-24VICKS ® NyQuil ® COLD & FLU
69423-995-24VICKS ® NyQuil ® COLD & FLU
69423-995-24VICKS ® NyQuil ® COLD & FLU
69423-995-24VICKS ® NyQuil ® COLD & FLU
69423-995-48VICKS ® NyQuil ® COLD & FLU
69423-995-48VICKS ® NyQuil ® COLD & FLU
69423-995-48VICKS ® NyQuil ® COLD & FLU
69423-995-48VICKS ® NyQuil ® COLD & FLU

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 89 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLRite Aid Corporation1affbef6-dd27-40c2-a5d3-b121aa62496a2025-11-15WarningsExact identifier
application number: M012
Cold and Flu Day, NightACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWalgreen Companyb9adfb5d-6576-4ff8-a7d7-a89b867c52922025-11-14WarningsExact identifier
application number: M012
PECGEN DMXDEXTROMETHORPHAN HBR, GUAIFENESINKRAMER NOVISa627824c-5e3d-4672-a047-6c801b50b4322025-11-14WarningsExact identifier
application number: M012
Supress DMDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINKRAMER NOVIS7da0611e-729c-4cf8-88f3-f8877b9f5cfa2025-11-14WarningsExact identifier
application number: M012
G-ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Novisc1aa7060-0f32-4ea1-8e2e-1aa131bd55fc2025-11-14WarningsExact identifier
application number: M012
Tussi Pres BDEXTROMETHORPHAN HYDROBROMIDE, BROMPHENIRAMINE MALEATE, PHENYLEPHRINE HYDROCHLORIDEKRAMER NOVISd0afa44c-3acf-42a5-9889-4e9c102252562025-11-14WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb2c0692c-ed0b-4fcf-b88d-59a788b124c62025-11-14WarningsExact identifier
application number: M012
Guaifenesin 400mgGUAIFENESINMarlex Pharmaceuticals Inc13f4db4e-687e-9d7b-e063-6294a90ab0882025-11-13WarningsExact identifier
application number: M012
Guaifenesin 200mgGUAIFENESINMarlex Pharmaceuticals Inc13b8f480-d1ac-d70c-e063-6394a90ab4f42025-11-13WarningsExact identifier
application number: M012
Diphenhydramine HCLDIPHENHYDRAMINE HCLPD-Rx Pharmaceuticals, Inc.c1873a4c-661f-4896-bcc0-f6d3a655de942025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief NighttimeACETAMINOPHEN, DIPHENHYDRAMINE HCLHaleon US Holdings LLCc24b9489-208c-472b-8ae5-c6e86c12e04d2025-11-13WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief Chest Congestion DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLC8c821671-dc68-4e27-aa87-b4e45ade98172025-11-13WarningsExact identifier
application number: M012
Robitussin Maximum Strength Severe Cough Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDEHaleon US Holdings LLC6a6f5da8-6433-4284-8df7-2d5b099b74dc2025-11-13WarningsExact identifier
application number: M012
equaline allergyDIPHENHYDRAMINE HCLUnited Natural Foods, Inc. dba UNFI8e4eb1eb-5b55-4531-94d2-998425ec80ed2025-11-13WarningsExact identifier
application number: M012
Cold and Flu DayTimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDESafeway, Inc.7a78f24b-7c23-4318-99dc-90c05db185b12025-11-13WarningsExact identifier
application number: M012
ZYNCOFDEXTROMETHORPHAN HBR AND GUAIFENESINKramer Noviscffd6d5f-0cb2-4d38-bdb0-6a21120418cc2025-11-13WarningsExact identifier
application number: M012
equate vapor ice cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEWal-Mart Stores Incb6da1659-8c79-4cce-a817-907a7f061a2d2025-11-13WarningsExact identifier
application number: M012
Tussi PresGUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDEKramer Novis0d4ee530-2a5c-41a0-88bf-ac92d538661b2025-11-12WarningsExact identifier
application number: M012
4 Way Fast ActingPHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLCa8fc41c7-4425-41b8-b1c6-eb22ac0547342025-11-12WarningsExact identifier
application number: M012
Quality Choice Vapor SteamCAMPHOR (SYNTHETIC)Chain Drug Marketing Association, Inc.1f1e6be5-d407-330c-e063-6294a90a4e802025-11-12WarningsExact 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