FDA.reportPublic FDA data

Vicks NyQuil Kids ALLERGY

Product NDC
84126-345
11-digit product format
841260345
Labeler code
84126
Product ID
84126-345_5d18d45f-8284-5fe0-e063-6294a90a4139
Type
HUMAN OTC DRUG
Nonproprietary name
Doxylamine Succinate
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-01
Substance
DOXYLAMINE SUCCINATE
Active strength
6.25 mg/15mL
Pharmacologic classes
Antihistamine [EPC], Histamine 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 Kids ALLERGY
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE6.25 mg/15mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-345-08Vicks NyQuil Kids ALLERGY236 mL in 1 BOTTLE, PLASTICLIQUID2362

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 163 of 178 · 3,550 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Childrens Plus Multi Symptom ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDE, PHENYLEPHRINE HYDROCHLORIDEWalgreensdd967cfb-96b4-4cdc-82e2-a4838001c9e32024-05-08WarningsExact identifier
application number: M012
Childrens Wal Tap Elixer Cold and AllergyBROMPHENIRAMINE MALEATE, PHENYLEPHRINE HCLWalgreens3f438f28-d1ad-44da-a573-f1b0824b051c2024-05-08WarningsExact identifier
application number: M012
Cough Cold and Sore Throat ChildrensACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWalgreens400a0998-e276-4c8d-9b41-145b1b405fff2024-05-08WarningsExact identifier
application number: M012
Mucus Congestion and Cough Relief ChildrensDEXTROMETHORPHAN HBR, GUAIFENSIN, PHENYLEPHRINE HCIWalgreens19cd2409-d56b-4319-833c-eacc7dc498c12024-05-08WarningsExact identifier
application number: M012
Severe Cold and Flu Nighttime HoneyACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLKroger10b12f0e-dba7-fd71-e063-6294a90a42c12024-05-06WarningsExact identifier
application number: M012
Daytime Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL AND ACETAMINOPHEN, DEXTROMETHORPHAN HBRDOXYLAMINE SUCCINATEKroger10b15337-b9c5-4dc8-e063-6394a90ac0562024-05-06WarningsExact identifier
application number: M012
Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLKroger1014da86-3a0e-136f-e063-6294a90ac9312024-05-04WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Cough and Chest Congestion DMDEXTROMETHORPHAN HBR, GUAIFENESINHaleon US Holdings LLCeaa10aed-5b1e-48bf-bc05-7a5638851daf2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal DecongestantACETAMINOPHEN, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLCe35cb719-9e7d-4b2b-81a4-29e147dd74fa2024-05-03WarningsExact identifier
application number: M012
Theraflu-D Flu Relief Max Strength plus Nasal Decongestant NighttimeACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PSEUDOEPHEDRINE HCLHaleon US Holdings LLC09e20842-2b75-43b9-ae5f-3515b35e655b2024-05-03WarningsExact identifier
application number: M012
Cold and Flu ReliefACETAMINOPHEN DEXTROMETHORPHAN HBR PHENYLEPHRINE HCLFamily Dollar (FAMILY WELLNESS)f958d8ba-ede9-4b1a-8317-2404b68a91292024-05-03WarningsExact identifier
application number: M012
Daytime Nighttime Cold and Flu Relief Multi-SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWinCo Foods, LLCfab57d70-ba54-416f-9f14-b64d2238ea162024-05-03WarningsExact identifier
application number: M012
Tussin CF Non Drowsy Multi SymptomDEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWinCo Foods, LLC8ee27600-4f8e-406a-8ea3-eade691448f62024-05-03WarningsExact identifier
application number: M012
SanaTos Children Cough and Congestion CherryDEXTROMETHORPHAN HBR AND GUAIFENESINPharmadel LLC60437d86-9e13-8d8a-e053-2991aa0a23172024-05-02WarningsExact identifier
application number: M012
Robitussin Honey Maximum Strength Nighttime Cough DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEHaleon US Holdings LLC0b41da13-18a1-4987-ae43-1319bfa274842024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)07c7c0d9-f063-4efc-8a08-2a1bfa9ca84a2024-05-01WarningsExact identifier
application number: M012
Night Time Cold and Flu Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEQUALITY CHOICE (Chain Drug Marketing Association)dbfb8971-a122-4a97-a665-e3f0d494876e2024-05-01WarningsExact identifier
application number: M012
Daytime Cold and Flu Non DrowsyACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLP & L Development, LLCc08b150c-d821-466c-8521-f77535d6af1e2024-04-30WarningsExact identifier
application number: M012
childrens allergy reliefDIPHENHYDRAMINE HYDROCHLORIDEWalgreen Company7848bb09-2af8-47f6-b32d-96635a750a552024-04-29WarningsExact identifier
application number: M012
NASAL and SINUS DECONGESTANTPHENYLEPHRINE HYDROCHLORIDEJHK Inc dba American Safety & First Aid63e51305-2575-49c4-9fda-7b3e1b4b6ede2024-04-26WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715412doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN2f9a6d65-f849-af0a-e063-6394a90ae4352
2715412doxylamine succinate 0.417 MG/ML Oral SolutionSCD2f9a6d65-f849-af0a-e063-6394a90ae4352
2715412doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY2f9a6d65-f849-af0a-e063-6394a90ae4352

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-345-0884126034508236 mL in 1 BOTTLE, PLASTIC (84126-345-08) 236 ml2025-06-01NoNoCurrent