FDA.reportPublic FDA data

VICKS NyQuil Kids

Product NDC
84126-311
11-digit product format
841260311
Labeler code
84126
Product ID
84126-311_5d1a1e3f-4187-35f9-e063-6294a90a5cef
Type
HUMAN OTC DRUG
Nonproprietary name
Diphenhydramine Hydrochloride
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-06-25
Substance
DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
12.5 mg/15mL
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
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 Kids
Brand name suffix
FREE OF ARTIFICIAL DYES AND SUGAR COLD and COUGH plus RUNNY NOSE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIPHENHYDRAMINE HYDROCHLORIDE12.5 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
84126-311-06VICKS NyQuil KidsFREE OF ARTIFICIAL DYES AND SUGAR COLD and COUGH plus RUNNY NOSE177 mL in 1 BOTTLE, PLASTICLIQUID1774
84126-311-06Vicks DayQuil Kids and Vicks NyQuil KidsFREE OF ARTIFICIAL DYES and SUGAR COLD and COUGH plus177 mL in 1 BOTTLE, PLASTICLIQUID177 mL12.5 mg in 15mL3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-311VICKS NYQUIL KIDS FREE OF ARTIFICIAL DYES AND SUGAR COLD AND COUGH PLUS RUNNY NOSE (DIPHENHYDRAMINE HYDROCHLORIDE) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]2Current NDC, 1 package rows20240625_81ef58de-7e65-446f-98f0-fb88027124ce.zip
84126-311VICKS 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

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 115 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Tussin DM Sugar freeDEXTROMETHORPHAN HBR AND GUAIFENESINAARNA USA, Inc.3a521b65-fb35-4cc3-b826-88513afda0f92025-05-16WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRHaleon US Holdings LLC51c7628a-c7cf-498f-8fb1-db732e2b8b6e2025-05-16WarningsExact identifier
application number: M012
BACTIMICINA CHILDRENS ALLERGYDIPHENHYDRAMINE HYDROCHLORIDEDLC Laboratories, Inc.eaf554d4-a758-4ed6-bec5-d6cbfedae4082025-05-15WarningsExact identifier
application number: M012
Bactimicina Childrens Cough and ColdCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEDLC Laboratories, Inc.d407a583-07ae-4d47-b15a-24b5865c82da2025-05-15WarningsExact identifier
application number: M012
Mucinex Nightshift Sinus Maximum StrengthACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, AND TRIPROLIDINE HYDROCHLORIDERB Health (US) LLC35322238-d498-1a52-e063-6394a90ac9c42025-05-15WarningsExact identifier
application number: M012
Theraflu Flu Relief Max Strength DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLCa1405038-80f2-45e5-bd8c-8c6b0ee348be2025-05-15WarningsExact identifier
application number: M012
Cold ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIb919f0fe-fae0-4bd8-9ccd-d7569b2a70702025-05-13WarningsExact identifier
application number: M012
Childrens Robitussin Honey Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC6afaf85b-bf0c-4c99-acf3-a34f06be20f12025-05-13WarningsExact identifier
application number: M012
Robitussin Honey Severe Cough, Flu Plus Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC77be57fb-0ae5-4fad-97f3-b6a4b57383a92025-05-13WarningsExact identifier
application number: M012
AllergyCHLORPHENIRAMINE MALEATEBryant Ranch Prepackc948e612-a491-4ad0-adb9-cf31ef76e4d82025-05-12WarningsExact identifier
application number: M012
Maximum Strength Nighttime Severe Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HYDROCHLORIDEProdose, Inc.c3d0b70f-d213-4e38-88ab-1c89d93a391d2025-05-10WarningsExact identifier
application number: M012
Childrens AllergyDIPHENHYDRAMINE HYDROCHLORIDESafeway, Inc.c639a36d-c683-4a4d-90b7-eadec7464aa22025-05-08WarningsExact identifier
application number: M012
Severe ColdACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFIcf2dd1fb-1d5b-428e-8c9a-a46dbd7cb6452025-05-07WarningsExact identifier
application number: M012
Theraflu Severe Cold Relief DaytimeACETAMINOPHEN, DEXTROMETHORPHAN HBRHaleon US Holdings LLC2b962d87-6ff5-4c0f-8504-e5b61c9406122025-05-05WarningsExact identifier
application number: M012
Cough and Sore ThroatACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE LIQUIDCVS2d13564a-e8d1-c357-e063-6394a90ad90e2025-05-02WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal Mist with Cooling MentholOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33fe0e49-3de5-8afd-e063-6294a90a0ad52025-05-02WarningsExact identifier
application number: M012
Daytime and Nighttime High Blood Pressure Cold and Flu LiquidACETAMINOPHEN, DEXTROMETHORPHAN HBR AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacy, Inc.2d13964a-8cc4-f3dc-e063-6394a90aa1052025-05-02WarningsExact identifier
application number: M012
DIPHENHYDRAMINE HCL 12.5 MG PER 5 MLDIPHENHYDRAMINE HCL 12.5 MG PER 5 MLAARNA USA INC.32c26835-f54e-d7e5-e063-6294a90ae1c02025-04-30WarningsExact identifier
application number: M012
SUDAFED OM Sinus Severe No Drip Nasal MistOXYMETAZOLINE HYDROCHLORIDEKenvue Brands LLC33e6239b-364a-0e62-e063-6294a90a50472025-04-29WarningsExact identifier
application number: M012
Childrens Allergy ReliefDIPHENHYDRAMINE HCLCVS Pharmacy8296049c-72fc-4200-9d45-c8e377314cf22025-04-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2685488diphenhydrAMINE hydrochloride 12.5 MG in 15 mL Oral SolutionPSN81ef58de-7e65-446f-98f0-fb88027124ce4
2685488diphenhydramine hydrochloride 0.833 MG/ML Oral SolutionSCD81ef58de-7e65-446f-98f0-fb88027124ce4
2685488diphenhydramine hydrochloride 12.5 MG per 15 mL Oral SolutionSY81ef58de-7e65-446f-98f0-fb88027124ce4
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 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 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 SolutionSY1a143600-24b0-75dc-e063-6394a90afb533
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
84126-311-0684126031106177 mL in 1 BOTTLE, PLASTIC (84126-311-06) 177 ml2024-06-25NoNoCurrent