FDA.reportPublic FDA data

Vicks NyQuil-D

Product NDC
84126-364
11-digit product format
841260364
Labeler code
84126
Product ID
84126-364_5ce1023d-ccd4-8f93-e063-6294a90aa069
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Pseudoephedrine HCl, Doxylamine Succinate, Dextromethorphan HBr
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-09-08
Substance
DOXYLAMINE SUCCINATE; ACETAMINOPHEN; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
Active strength
6.25; 500; 15; 30 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha-Agonists [MoA], 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], alpha-Adrenergic Agonist [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-D
Brand name suffix
COLD and SINUS plus SEVERE CONGESTION
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DOXYLAMINE SUCCINATE6.25 mg/1
ACETAMINOPHEN500 mg/1
DEXTROMETHORPHAN HYDROBROMIDE15 mg/1
PSEUDOEPHEDRINE HYDROCHLORIDE30 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
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
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
0fdb98e2-b951-a1ce-5715-2b187ba500efProduct name420170718
377068df-225f-7318-a910-a1987cdfa361Product name320170608
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229
e974e22d-8688-7d92-1e87-40c1079e170cProduct name320151125
4fe95224-f543-4dbb-9445-8cca122b48c8Product name120150609
e8718272-64cb-4436-969b-176c3067c8f4Product name120150609
106ff02a-57e1-4c4c-a307-fd582ff4e311Product name120150212
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
30c51294-7ae9-8007-7de6-58222684a0beProduct name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
4f26f669-fc6c-40ef-9e26-1c7b2390ee66Product name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
70a83adc-6047-bbea-5a08-dfd304aa47d2Product name120140508
76633df9-0d59-4b88-03ed-21dee1b966f8Product name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
858ce051-9941-aafc-8c7c-44a8e0227463Product name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
b893258d-0942-3d8a-3411-056ea0788ff5Product name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product 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
84126-364-12Vicks NyQuil-DCOLD and SINUS plus SEVERE CONGESTION12 in 1 BOTTLECAPSULE, LIQUID FILLED121

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 107 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ACTIDOGESICDEXBROMPHENIRAMINE MALEATE, ACETAMINOPHENACTIPHARMA, LLC697da3f9-9888-4d41-ba83-87ca9bf1e54b2025-08-18WarningsExact identifier
application number: M012
Night Time Cold and Flu Relief Multi SymptomACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERite Aid Corporation5f9c9c48-4e8f-4ace-a6fb-1c1bccaf02a02025-08-18WarningsExact identifier
application number: M012
MAJOR NASAL DECONGESTANTOXYMETAZOLINE HYDROCHLORIDEA-S Medication Solutions4b78b9af-0975-43f8-8b44-daddef0478be2025-08-15WarningsExact identifier
application number: M012
Dr Simi Mucus Relief ExpectorantGUAIFENESINFarmacias De Similares TX LLC3c6d0e75-a685-6020-e063-6294a90a5c1b2025-08-15WarningsExact identifier
application number: M012
Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATERite Aid Corporation25bf4390-23f7-4bb6-b86e-c40eaf8d92da2025-08-15WarningsExact identifier
application number: M012
Childrens Chewable Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEKROGER COMPANY2cac72be-4830-ad49-e063-6394a90a78322025-08-14WarningsExact identifier
application number: M012
GOOD NEIGHBOR PHARMACY MUCUS RELIEF DM MAXIMUM STRENGTHDEXTROMETHORPHAN HBR AND GUAIFENESINAMERISOURCE BERGEN2ea1e7bf-1bb9-4627-bbd4-4a78920a8b6e2025-08-12WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWalmart Inc.16fae164-28db-8ef1-e063-6294a90ab5da2025-08-12WarningsExact identifier
application number: M012
Exchange Select Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.fbece335-a7e5-4732-a086-561b237415792025-08-12WarningsExact identifier
application number: M012
MGC Health Cough Drops Original HerbMENTHOLXiamen Kang Zhongyuan Biotechnology Co., Ltd.779ddb89-b6e2-4bfb-bcb5-8c7ec916675a2025-08-12WarningsExact identifier
application number: M012
Equaline NasalOXYMETAZOLINE HYDROCHLORIDEUnited Natural Foods, Inc. dba UNFId7fa1720-eac4-4e82-9401-77215ce4f5452025-08-12WarningsExact identifier
application number: M012
Diabetic Tussin DM Maximum StrengthDEXTROMETHORPHAN HYDROBROMIDE AND GUAIFENESINMEDTECH PRODUCTS INCa10a3b33-7503-4334-8ed7-2bb881df43272025-08-08WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDECabinet Health, Inc26a55d74-f772-5d17-e063-6394a90a55832025-08-07WarningsExact identifier
application number: M012
Daytime SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDEH E Bb7434978-44a8-4c51-979d-0bc446461e432025-08-06WarningsExact identifier
application number: M012
Tussin DMDEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATECVS Pharmacyfc1e224c-5c57-43fc-ae6e-36aa0a4ae4392025-08-06WarningsExact identifier
application number: M012
childrens cold cough dmBROMPHENIRAMINE MALEATE, DEXTROMETHORPHAN HYDROBROMIDEPublix Super Markets Inc6efe7097-2a99-4654-9d94-b47f2e64d19d2025-08-05WarningsExact identifier
application number: M012
Quality Choice Throat Soothing Drops Creamy StrawberryPECTINChain Drug Marketing Association, Inc.3b7548ee-7cd3-62c3-e063-6294a90a06122025-08-03WarningsExact identifier
application number: M012
Vaporizing chest rubCAMPHOR, EUCALYPTUS OIL, MENTHOLLJ Pharma065bb666-e482-4e96-ac75-c6577dcc5b482025-08-01WarningsExact identifier
application number: M012
Nighttime Cough-KidsCHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRGenexa024bb864-4214-1d8b-e063-6394a90aa5732025-08-01WarningsExact identifier
application number: M012
Antigrip Cough and ColdACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBRPharmadel LLC3b53e5fc-f258-c2b9-e063-6394a90ab5002025-08-01WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2723023{1 (acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG Oral Capsule) / 1 (acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG Oral Capsule) } PackGPCK3c1cbe58-f5a2-c96e-e063-6294a90a74e61
27230231 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG Oral Capsule) / 1 nighttime (acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG Oral Capsule)PSN3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723022acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaiFENesin 200 MG / pseudoephedrine HCl 30 MG Oral CapsulePSN3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723021acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG Oral CapsulePSN3c176ea9-62a0-b86f-e063-6294a90ab8f71
2723021acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG Oral CapsulePSN3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723022acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSCD3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723021acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSCD3c176ea9-62a0-b86f-e063-6294a90ab8f71
2723021acetaminophen 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSCD3c1cbe58-f5a2-c96e-e063-6294a90a74e61
27230231 daytime (acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / pseudoephedrine HCl 30 MG Oral Capsule) / 1 nighttime (acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG Oral Capsule) PackSY3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723022acetaminophen 325 MG / dextromethorphan HBr 10 MG / guaifenesin 200 MG / pseudoephedrine HCl 30 MG Oral CapsuleSY3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723021acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG Oral CapsuleSY3c176ea9-62a0-b86f-e063-6294a90ab8f71
2723021acetaminophen 500 MG / dextromethorphan HBr 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine HCl 30 MG Oral CapsuleSY3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723022APAP 325 MG / dextromethorphan hydrobromide 10 MG / guaifenesin 200 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSY3c1cbe58-f5a2-c96e-e063-6294a90a74e61
2723021APAP 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSY3c176ea9-62a0-b86f-e063-6294a90ab8f71
2723021APAP 500 MG / dextromethorphan hydrobromide 15 MG / doxylamine succinate 6.25 MG / pseudoephedrine hydrochloride 30 MG Oral CapsuleSY3c1cbe58-f5a2-c96e-e063-6294a90a74e61

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
84126-364-128412603641212 CAPSULE, LIQUID FILLED in 1 BOTTLE (84126-364-12) 2025-09-08NoNoCurrent