FDA.reportPublic FDA data

Vicks NyQuil

Product NDC
84126-357
Requested package NDC
84126-357-08
11-digit product format
841260357
Labeler code
84126
Product ID
84126-357_5d1aef37-73c8-3753-e063-6294a90a0bed
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Dextromethorphan Hydrobromide, 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
ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; DOXYLAMINE SUCCINATE
Active strength
1000; 30; 12.5 mg/30mL; mg/30mL; mg/30mL
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
INTENSE FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN1000 mg/30mL
DEXTROMETHORPHAN HYDROBROMIDE30 mg/30mL
DOXYLAMINE SUCCINATE12.5 mg/30mL

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
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6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
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d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
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53855190-7124-8179-f018-e792f7c27f28Product name120140508
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
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c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
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cd4f9ae2-1343-ecd2-ce0f-97db0c2b51ceProduct name120140508
cf3a804d-0326-aa22-0142-c184b5657d85Product name120140508
d83c592c-dd97-4cbf-36ac-13da806684bdProduct name120140508
e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-357-08Vicks NyQuilINTENSE FLU236 mL in 1 BOTTLE, PLASTICLIQUID2362
84126-357-12Vicks NyQuilINTENSE FLU354 mL in 1 BOTTLE, PLASTICLIQUID3542
84126-357-12Vicks DayQuil and Vicks NyQuilINTENSE FLU354 mL in 1 BOTTLE, PLASTICLIQUID354 mL12.5 mg in 30mL1

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 154 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sugar Free Cough DropsMENTHOLTopco Associates LLCefcf2edd-21a3-45f9-e053-2995a90a38652024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff65505-8846-35c2-e053-2a95a90a6b792024-10-07WarningsExact identifier
application number: M012
Sugar Free Cough DropsMENTHOLTopco Associates LLCeff0fdfe-695a-4e62-e053-2a95a90ab50f2024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff1a70f-fa71-52b2-e053-2995a90a038c2024-10-07WarningsExact identifier
application number: M012
Honey Lemon Menthol Cough DropsHONEY LEMON MENTHOLTopco Associates LLCf5be283b-524d-26af-e053-2995a90a39722024-10-07WarningsExact identifier
application number: M012
Cough DropsMENTHOLTopco Associates LLCeff16ba3-7e30-aa93-e053-2995a90a64cb2024-10-07WarningsExact identifier
application number: M012
Menthol Cough DropsMENTHOLTarget Corporation Inc.ebf6bcf5-9384-052a-e053-2a95a90a30a52024-10-07WarningsExact identifier
application number: M012
Rompe Pecho SF Flu SF FluBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBREfficient Laboratories Inc06eac696-e8f6-ac50-e063-6394a90a2ed62024-10-07WarningsExact identifier
application number: M012
dg health nasal fourPHENYLEPHRINE HYDROCHLORIDEDolgencorp, LLCceeeb016-8e46-40b8-9923-8a4270475f452024-10-04WarningsExact identifier
application number: M012
Topcare Nasal FourPHENYLEPHRINE HYDROCHLORIDETopco Associates LLC99bc8829-167b-4cf8-8421-57da369f24cd2024-10-04WarningsExact identifier
application number: M012
basic care nasalPHENYLEPHRINE HYDROCHLORIDEAmazon.com Services LLC858648f6-f454-4008-9ea8-ad060c2178332024-10-04WarningsExact identifier
application number: M012
Alka-Seltzer Plus Severe Cold and Flu PowerFast FizzCHLORPHENIRAMINE MALEATE, ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DEXTROMETHORPHAN HYDROBROMIDENavajo Manufacturing Company Inc.f6068011-ad56-59b4-e053-2995a90ac0162024-10-03WarningsExact identifier
application number: M012
Benadryl UltratabsDIPHENHYDRAMINE HYDROCHLORIDENavajo Manufacturing Company Inc.76433e3c-142c-4704-8b2b-d602f008c3772024-10-02WarningsExact identifier
application number: M012
AfrinOXYMETAZOLINE HYDROCHLORIDENavajo Manufacturing Company Inc.65bf1556-f234-9439-e053-2a91aa0a31942024-10-02WarningsExact identifier
application number: M012
Nasal DecongestantPSEUDOEPHEDRINE HCLProficient Rx LP4eab4344-d95e-4b19-a21e-9c8ad033863a2024-10-01WarningsExact identifier
application number: M012
pseudoephedrine hydrochloridePSEUDOEPHEDRINE HCLProficient Rx LPa910320b-0585-40bd-928c-0406346281d02024-10-01WarningsExact identifier
application number: M012
CareOne Nasal and Sinus DecongestantPSEUDOEPHEDRINE HCLAmerican Sales Company81b31070-9b03-4ce4-8aac-a334544842ae2024-10-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINProficient Rx LP20f35f9f-5f3b-4305-b9e4-ab9a8fae9c1d2024-10-01WarningsExact identifier
application number: M012
meijer Nighttime Cold and Flu SOFTGELACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEMeijer, Inc.1bec5167-5fc5-2405-e063-6294a90a53582024-09-30WarningsExact identifier
application number: M012
good sense tussin dmDEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESINA-S Medication Solutions19b3db33-86d1-48f3-9525-c7c87a4b68992024-09-29WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1042684acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN326e3a20-7bcb-0e24-e063-6394a90af3272
1042684acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD326e3a20-7bcb-0e24-e063-6394a90af3272
1042684acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY326e3a20-7bcb-0e24-e063-6394a90af3272
1042684acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY326e3a20-7bcb-0e24-e063-6394a90af3272
1042684APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY326e3a20-7bcb-0e24-e063-6394a90af3272
1242575{1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral Solution) / 1 (acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral Solution) } PackGPCK32bea3dc-9889-22dd-e063-6394a90afa1b1
12425751 nighttime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral Solution) / 1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG in 15 mL Oral Solution) PackPSN32bea3dc-9889-22dd-e063-6394a90afa1b1
1042684acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG in 15 mL Oral SolutionPSN32bea3dc-9889-22dd-e063-6394a90afa1b1
1359455acetaminophen 500 MG / dextromethorphan HBr 15 MG in 15 mL Oral SolutionPSN32bea3dc-9889-22dd-e063-6394a90afa1b1
1042684acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSCD32bea3dc-9889-22dd-e063-6394a90afa1b1
1359455acetaminophen 33.3 MG/ML / dextromethorphan hydrobromide 1 MG/ML Oral SolutionSCD32bea3dc-9889-22dd-e063-6394a90afa1b1
12425751 nighttime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral Solution) / 1 daytime (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral Solution) PackSY32bea3dc-9889-22dd-e063-6394a90afa1b1
1042684acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG / doxylamine succinate 12.5 MG per 30 ML Oral SolutionSY32bea3dc-9889-22dd-e063-6394a90afa1b1
1359455acetaminophen 1000 MG / dextromethorphan hydrobromide 30 MG per 30 ML Oral SolutionSY32bea3dc-9889-22dd-e063-6394a90afa1b1
1042684acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG per 15 ML Oral SolutionSY32bea3dc-9889-22dd-e063-6394a90afa1b1
1359455acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG per 15 ML Oral SolutionSY32bea3dc-9889-22dd-e063-6394a90afa1b1
1042684APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML / doxylamine succinate 0.417 MG/ML Oral SolutionSY32bea3dc-9889-22dd-e063-6394a90afa1b1
1359455APAP 33.3 MG/ML / Dextromethorphan Hydrobromide 1 MG/ML Oral SolutionSY32bea3dc-9889-22dd-e063-6394a90afa1b1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-357-0884126035708236 mL in 1 BOTTLE, PLASTIC (84126-357-08) 236 ml2025-07-07NoNoCurrent