FDA.reportPublic FDA data

Vicks NyQuil ALLERGY

Product NDC
84126-346
11-digit product format
841260346
Labeler code
84126
Product ID
84126-346_5d18d6f8-e38a-a208-e063-6394a90abffc
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
2025-07-01
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 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
84126-346-12Vicks NyQuil ALLERGY354 mL in 1 BOTTLE, PLASTICLIQUID3543
84126-346-24Vicks NyQuil ALLERGY2 in 1 CARTONLIQUID23
84126-346-24Vicks NyQuil ALLERGY354 mL in 1 BOTTLE, PLASTICLIQUID3543

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 155 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nasal decongestant maximum strength non drowsyPSEUDOEPHEDRINE HCLMeijer Distribution Inc8a68ca99-fd76-409a-9769-88830e8720a82024-09-28WarningsExact identifier
application number: M012
good neighbor pharmacy tussin dm maxDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINAmerisource Bergen58687394-b6d2-4d51-bde0-8f2cfa3fe9092024-09-27WarningsExact identifier
application number: M012
good neighbor pharmacy nasalOXYMETAZOLINE HYDROCHLORIDEAmerisource Bergenfaee3aae-e819-4084-a127-3449be353b132024-09-27WarningsExact identifier
application number: M012
Tesalon ChildrenACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAFEISIN USP, PHENYLEPHRINE HCLOPMX LLC2309620a-ccbc-41e9-e063-6394a90a95202024-09-26WarningsExact identifier
application number: M012
adult cough and chest congestionDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINMeijer, Inc.b11c4cee-bbb5-4585-9d38-6787553e13a02024-09-26WarningsExact identifier
application number: M012
COLD AND FLU NIGHTTIME SEVEREACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLTARGET CORP9de9c34e-a0ca-cdf9-e053-2a95a90a93d32024-09-25WarningsExact identifier
application number: M012
Basic Care Daytime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLAmazon.com Services LLC8f3317f6-4ae8-474b-93c3-25e256519cb82024-09-25WarningsExact identifier
application number: M012
berkley and jensen tussin dmDEXTROMETHORPHAN HBR, GUAIFENESINBJWCb2de91c9-6af0-4881-8d2d-a69d90c8dfcd2024-09-24WarningsExact identifier
application number: M012
Tussin DM Cough and Chest Non DrowsyDEXTROMETHORPHAN HBR, GUAIFENESINWinCo Foods, LLC13eb459c-3075-4038-8062-9ee7175b2ab92024-09-24WarningsExact identifier
application number: M012
equaline nasal decongestant non drowsy maximum strengthPSEUDOEPHEDRINE HCLUnited Natural Foods, Inc. dba UNFI8897580a-709a-4643-8264-ad003d90cbff2024-09-22WarningsExact identifier
application number: M012
Chest RubCAMPHOR (SYNTHETIC), EUCALYPTUS OIL, AND MENTHOLDabur India Limited22916978-303d-e62a-e063-6394a90a21002024-09-20WarningsExact identifier
application number: M012
Topcare Nasal Decongestant Maximum Strength Non DrowsyPSEUDOEPHEDRINE HCLTopco Associates LLC1a9e0336-c0c2-43f8-aeea-668d4a2097142024-09-20WarningsExact identifier
application number: M012
Leader Nasal DecongestantPSEUDOEPHEDRINE HCLCardinal Health 110, LLC. dba Leader25609b66-047c-46e7-bc95-20eb8e6c96172024-09-20WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLCVS Pharmacybebe5e78-09ba-4d35-9d34-9f5e343414782024-09-20WarningsExact identifier
application number: M012
equaline nasalPHENYLEPHRINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFI67fdd277-7a7a-4404-8ca2-39802c46405f2024-09-20WarningsExact identifier
application number: M012
equaline tussinDEXTROMETHORPHAN HBR, GUAIFENESINUnited Natural Foods, Inc. dba UNFI8bc7fa7c-d565-48c9-9808-1042c3e9d4282024-09-20WarningsExact identifier
application number: M012
Leader Adult Tussin Mucus and Chest Congestion 541GUAIFENESINCARDINAL HEALTH 110, LLC. DBA LEADERd7fae410-9c1c-4231-9fde-2c51ad3d7e952024-09-20WarningsExact identifier
application number: M012
sinusPSEUDOEPHEDRINE HYDROCHLORIDEKroger Company18812f2a-9b66-45a7-9631-123da6fd1c1f2024-09-20WarningsExact identifier
application number: M012
Good Sense Nasal FourPHENYLEPHRINE HYDROCHLORIDEL. Perrigo Company930469c1-384c-4440-b3e6-9dcd674871c42024-09-19WarningsExact identifier
application number: M012
Cold and Flu Relief Multi Symptom NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWinCo Foods, LLC89272d2d-5533-4ae8-865b-cb204cec6d652024-09-17WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2715412doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN2f9b3bbb-4494-065d-e063-6294a90afcd23
2715412doxylamine succinate 0.417 MG/ML Oral SolutionSCD2f9b3bbb-4494-065d-e063-6294a90afcd23
2715412doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY2f9b3bbb-4494-065d-e063-6294a90afcd23

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-346-1284126034612354 mL in 1 BOTTLE, PLASTIC (84126-346-12) 354 ml2025-07-01NoNoCurrent
84126-346-24841260346242 BOTTLE, PLASTIC in 1 CARTON (84126-346-24) / 354 mL in 1 BOTTLE, PLASTIC2025-07-01NoNoCurrent