FDA.reportPublic FDA data

Vicks NyQuil VapoCOOL

Product NDC
84126-353
11-digit product format
841260353
Labeler code
84126
Product ID
84126-353_5d1b00fb-b689-95aa-e063-6394a90a8554
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Doxylamine Succinate, Dextromethorphan Hydrobromide
Dosage form
TABLET, COATED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-06
Substance
ACETAMINOPHEN; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 6.25; 10 mg/1; mg/1; mg/1
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 VapoCOOL
Brand name suffix
COLD and FLU
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
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
43a1ed49-eae2-4840-8075-cb4b33478540Product name120230425
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
ba088a92-ab5e-b2d4-e908-f5ea691b7587Product name720210201
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
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
c35d1ac8-8885-2ee1-6c52-5a715b242c00Product name120140508
c8753a88-edde-8e17-a396-705537b52ceeProduct name120140508
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
84126-353-02Vicks NyQuil VapoCOOLCOLD and FLU2 in 1 POUCHTABLET, COATED26
84126-353-24Vicks NyQuil VapoCOOLCOLD and FLU12 in 1 CARTONTABLET, COATED126
84126-353-24Vicks NyQuil VapoCOOLCOLD and FLU2 in 1 BLISTER PACKTABLET, COATED26

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-353VICKS NYQUIL VAPOCOOL COLD AND FLU (ACETAMINOPHEN, DOXYLAMINE SUCCINATE, DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, 3 package rows20250507_32819305-9bbd-8843-e063-6294a90a7f2e.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 41 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold and AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLDOLGENCORP, LLCb55452e1-25d0-4db5-9621-83f21ec6c2982026-04-06WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATEStrategic Sourcing Services LLCc9fa8d93-d9d6-4206-a13d-32b9e7555e7f2026-04-02WarningsExact identifier
application number: M012
Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLKroger Company6aaed3fe-ce35-4533-aea4-80096ce8e57a2026-04-02WarningsExact identifier
application number: M012
Nasal FourPHENYLEPHRINE HYDROCHLORIDEHyVee Inc19879fc8-4962-4c6e-87ed-b874d1d564af2026-04-01WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLLidl US LLC7227b330-590b-4731-8a58-e05a0233dd8a2026-04-01WarningsExact identifier
application number: M012
SudoGestCHLORPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HCLMajor Pharmaceuticals7cd8f7f3-c262-4f7c-bcaf-068be2c952f92026-04-01WarningsExact identifier
application number: M012
Sanatos Daytime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLPharmadel LLC4c26be18-733a-e4a8-e063-6294a90a8b022026-04-01WarningsExact identifier
application number: M012
Sanatos Nighttime ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEPharmadel LLC4c26c8bf-0143-ddca-e063-6294a90a35522026-04-01WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINMethod Pharmaceuticals, LLCfe126254-6ee6-48c3-965c-96e4276a53142026-04-01WarningsExact identifier
application number: M012
Good Neighbor Pharmacy Mucus ReliefGUAIFENESINAmerisourceBergen Drug Corp200dddd9-e3ff-4cec-a164-d1c9a698f1212026-03-31WarningsExact identifier
application number: M012
Head and ColdACETAMINOPHEN, GUAIFENESIN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLHi-Tech Nutraceuticals, LLCa39c772b-3cce-14cb-e053-2a95a90a733b2026-03-31WarningsExact identifier
application number: M012
diphenhydramine hydrochlorideDIPHENHYDRAMINE HYDROCHLORIDEHF Acquisition Co LLC, DBA HealthFirst44217a8c-7656-a0f6-e063-6294a90af2ad2026-03-31WarningsExact identifier
application number: M012
Dr Kids Cough and Chest CongestionDEXTROMETHORPHAN HBR, GUAIFENESINCalmCo LLC3f156679-7a91-aff1-e063-6394a90a18f62026-03-31WarningsExact identifier
application number: M012
Codeine-GuaifenesinCODEINE PHOSPHATE AND GUAIFENESINA-S Medication Solutionsc26da6e0-ab1c-46c2-acf5-0074958c03cd2026-03-31WarningsExact identifier
application number: M012
Flu HBP Maximum StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRCardinal Health 110, LLC. DBA Leaderba174fcc-da1e-420c-bf9c-179ad65c28482026-03-31WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLAmerisource Bergen8e0c6f8d-559c-45de-9362-1b713fd78a7a2026-03-30WarningsExact identifier
application number: M012
Dr. Simi Daytime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 10 MG, PHENYLEPHRINE HCL 5 MGFarmacias De Similares TX LLC4e448fd0-cb6b-b69b-e063-6394a90afde82026-03-30WarningsExact identifier
application number: M012
Dr. Simi Nighttime Cold and FluACETAMINOPHEN 325 MG, DEXTROMETHORPHAN HBR 15 MG, DOXYLAMINE SUCCINATE 6.25 MGFarmacias De Similares TX LLC4e5772ee-586c-6191-e063-6294a90a132d2026-03-30WarningsExact identifier
application number: M012
allergyDIPHENHYDRAMINE HCLHyVee Inc75b19163-db1c-42fc-8bbb-364be16b9b2f2026-03-30WarningsExact identifier
application number: M012
nasalOXYMETAZOLINE HYDROCHLORIDEHyVee Inca9f23c63-eeda-4de9-aec6-fe482f469e982026-03-27WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2713312acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral TabletPSN32819305-9bbd-8843-e063-6294a90a7f2e6
2713312acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral TabletSCD32819305-9bbd-8843-e063-6294a90a7f2e6
2713312APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral TabletSY32819305-9bbd-8843-e063-6294a90a7f2e6
2713313{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Tablet) / 1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Tablet) } PackGPCK32f95ea0-3f39-914b-e063-6294a90a2c615
27133131 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral Tablet) PackPSN32f95ea0-3f39-914b-e063-6294a90a2c615
2713312acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG Oral TabletPSN32f95ea0-3f39-914b-e063-6294a90a2c615
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletPSN32f95ea0-3f39-914b-e063-6294a90a2c615
2713312acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral TabletSCD32f95ea0-3f39-914b-e063-6294a90a2c615
2709673acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSCD32f95ea0-3f39-914b-e063-6294a90a2c615
27133131 daytime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG Oral Tablet) / 1 nighttime (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral Tablet) PackSY32f95ea0-3f39-914b-e063-6294a90a2c615
2709673acetaminophen 325 MG / dextromethorphan HBr 10 MG Oral TabletSY32f95ea0-3f39-914b-e063-6294a90a2c615
2713312APAP 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG Oral TabletSY32f95ea0-3f39-914b-e063-6294a90a2c615
2709673APAP 325 MG / dextromethorphan hydrobromide 10 MG Oral TabletSY32f95ea0-3f39-914b-e063-6294a90a2c615

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-353-02841260353022 TABLET, COATED in 1 POUCH (84126-353-02) 2025-05-06NoNoCurrent
84126-353-248412603532412 BLISTER PACK in 1 CARTON (84126-353-24) / 2 TABLET, COATED in 1 BLISTER PACK12 blister pack2025-05-06NoNoCurrent