FDA.reportPublic FDA data

Vicks DayQuil Kids

Product NDC
84126-310
11-digit product format
841260310
Labeler code
84126
Product ID
84126-310_5d1a1ae4-8a05-cd41-e063-6394a90aee2f
Type
HUMAN OTC DRUG
Nonproprietary name
Dextromethorphan HBr, Guaifenesin
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-25
Substance
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
Active strength
10; 200 mg/15mL; mg/15mL
Pharmacologic classes
Decreased Respiratory Secretion Viscosity [PE], Expectorant [EPC], Increased Respiratory Secretions [PE], 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 DayQuil Kids
Brand name suffix
FREE OF ARTIFICIAL DYES and SUGAR COLD and COUGH plus MUCUS
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DEXTROMETHORPHAN HYDROBROMIDE10 mg/15mL
GUAIFENESIN200 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-310-06Vicks DayQuil Kids and Vicks NyQuil KidsFREE OF ARTIFICIAL DYES and SUGAR COLD and COUGH plus177 mL in 1 BOTTLE, PLASTICLIQUID177 mL10 mg in 15mL3
84126-310-06Vicks DayQuil KidsFREE OF ARTIFICIAL DYES and SUGAR COLD and COUGH plus MUCUS177 mL in 1 BOTTLE, PLASTICLIQUID1773

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-310VICKS DAYQUIL KIDS AND VICKS NYQUIL KIDS FREE OF ARTIFICIAL DYES AND SUGAR COLD AND COUGH PLUS (DEXTROMETHORPHAN HBR, GUAIFENESIN, DIPHENHYDRAMINE HCL) KIT [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC20240625_1a143600-24b0-75dc-e063-6394a90afb53.zip
84126-310VICKS DAYQUIL KIDS FREE OF ARTIFICIAL DYES AND SUGAR COLD AND COUGH PLUS MUCUS (DEXTROMETHORPHAN HBR, GUAIFENESIN) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20240625_19b2422e-517c-8f94-e063-6394a90aba26.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 139 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Poly-Vent IRGUAIFENESIN AND PSEUDOEPHEDRINE HCLPoly Pharmaceuticals, Inc.ce0d8c45-446a-4df4-a36b-5000ba69d30d2024-11-09WarningsExact identifier
application number: M012
basic care tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmazon.com Services LLC306d5914-03ed-410a-9345-c54ba604e9912024-11-09WarningsExact identifier
application number: M012
care one nasal originalOXYMETAZOLINE HYDROCHLORIDEAmerican Sales Companya0c35e06-c9e9-438e-8224-d4760b6e2aff2024-11-09WarningsExact identifier
application number: M012
adult tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINWalgreen Company34174507-cf2e-4ed4-85ec-f915d4b910df2024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl ChewablesDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLCb08f71d8-a06c-41ba-8ed1-fbc41dbc19192024-11-08WarningsExact identifier
application number: M012
SUDAFED PE SINUS CONGESTIONDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCa38fdfb8-db89-487f-9b68-aa9152b91f5f2024-11-08WarningsExact identifier
application number: M012
SUDAFED Sinus CongestionPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLCc05d7e27-6821-468f-b27d-9c0b02a07b0f2024-11-08WarningsExact identifier
application number: M012
BenadrylDIPHENHYDRAMINE HYDROCHLORIDEKenvue Brands LLC2884d2dc-2d4a-4ca6-ab73-688a80b428eb2024-11-08WarningsExact identifier
application number: M012
Extra Strength TYLENOL Cold plus Flu Multi-Action Day/NightACETAMINOPHEN, PSEUDOEPHEDRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDE, AND CHLORPHENIRAMINE MALEATEKenvue Brands LLC712ba011-79aa-469b-9f0f-04a0b4b705bd2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC8538c291-9ce9-4866-b268-f4cbdb52f5bd2024-11-08WarningsExact identifier
application number: M012
Childrens Sudafed Nasal DecongestantPSEUDOEPHEDRINE HYDROCHLORIDEKenvue Brands LLC52e9307b-ad38-4f65-bb2f-4fa262e820102024-11-08WarningsExact identifier
application number: M012
Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC685b51d3-cc25-47b2-ac8a-368924f431372024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus Pressure Plus PainACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC60183922-bfd3-4377-884a-51b2f0a4c93a2024-11-08WarningsExact identifier
application number: M012
Sudafed PE Sinus CongestionPHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC2ca08917-1a75-4365-8520-c083e6a4225a2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus MucusACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCf0739186-41b9-4761-adf7-08101b30a18e2024-11-08WarningsExact identifier
application number: M012
SUDAFED PE Head Congestion Plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC1e528f78-0ced-4a06-935a-84056c9217272024-11-08WarningsExact identifier
application number: M012
TYLENOL Cold Plus Flu Severe and TYLENOL COLD MAX CoPackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC657a1e59-104c-4152-b2c9-00a8b82dc78e2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold plus Flu Severe and Tylenol Cold MaxACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC47c61858-72ce-409b-a3af-a63620cf7d132024-11-08WarningsExact identifier
application number: M012
Childrens Benadryl Allergy Plus CongestionDIPHENHYDRAMINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLCb8b75904-3806-4258-89c1-d6ff486ed41c2024-11-08WarningsExact identifier
application number: M012
Tylenol Cold Plus Flu Severe Day and Tylenol Cold Plus Flu Plus Cough Night 3-PackACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, AND GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEKenvue Brands LLC464de5de-0e7a-41d6-875f-dd0e5fe7893c2024-11-08WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685490{1 (dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral Solution) / 1 (diphenhydramine hydrochloride 0.833 MG/ML Oral Solution) } PackGPCK1a143600-24b0-75dc-e063-6394a90afb533
26854901 daytime (dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral Solution) / 1 nighttime (diphenhydrAMINE hydrochloride 12.5 MG in 15 mL Oral Solution) PackPSN1a143600-24b0-75dc-e063-6394a90afb533
1014005dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral SolutionPSN19b2422e-517c-8f94-e063-6394a90aba263
1014005dextromethorphan HBr 10 MG / guaiFENesin 200 MG in 15 mL Oral SolutionPSN1a143600-24b0-75dc-e063-6394a90afb533
2685488diphenhydrAMINE hydrochloride 12.5 MG in 15 mL Oral SolutionPSN1a143600-24b0-75dc-e063-6394a90afb533
1014005dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral SolutionSCD19b2422e-517c-8f94-e063-6394a90aba263
1014005dextromethorphan hydrobromide 0.667 MG/ML / guaifenesin 13.3 MG/ML Oral SolutionSCD1a143600-24b0-75dc-e063-6394a90afb533
2685488diphenhydramine hydrochloride 0.833 MG/ML Oral SolutionSCD1a143600-24b0-75dc-e063-6394a90afb533
26854901 daytime (dextromethorphan HBr 10 MG / guaifenesin 200 MG per 15 mL Oral Solution) / 1 nighttime (diphenhydramine hydrochloride 12.5 MG per 15 mL Oral Solution) PackSY1a143600-24b0-75dc-e063-6394a90afb533
1014005dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG per 15 ML Oral SolutionSY19b2422e-517c-8f94-e063-6394a90aba263
1014005dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG per 15 ML Oral SolutionSY1a143600-24b0-75dc-e063-6394a90afb533
1014005dextromethorphan hydrobromide 5 MG / guaifenesin 100 MG per 7.5 ML Oral SolutionSY19b2422e-517c-8f94-e063-6394a90aba263
1014005dextromethorphan hydrobromide 5 MG / guaifenesin 100 MG per 7.5 ML Oral SolutionSY1a143600-24b0-75dc-e063-6394a90afb533
2685488diphenhydramine hydrochloride 12.5 MG per 15 mL Oral SolutionSY1a143600-24b0-75dc-e063-6394a90afb533

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-310-0684126031006177 mL in 1 BOTTLE, PLASTIC (84126-310-06) 177 ml2024-06-25NoNoCurrent