FDA.reportPublic FDA data

Vicks NyQuil HOT REMEDY

Product NDC
58933-555
Requested package NDC
58933-555-01
11-digit product format
589330555
Labeler code
58933
Product ID
58933-555_4535d508-ff3e-13ae-e063-6394a90a15de
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Diphenhydramine HCl
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-11
Substance
ACETAMINOPHEN; DIPHENHYDRAMINE HYDROCHLORIDE
Active strength
650; 25 mg/1; mg/1
Pharmacologic classes
Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks NyQuil HOT REMEDY
Brand name suffix
Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN650 mg/1
DIPHENHYDRAMINE HYDROCHLORIDE25 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
362O9ITL9DInternal UNII lookup
TC2D6JAD40Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2670677Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4535d4fe-9de7-f2c6-e063-6394a90a944aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
bf324df6-7127-7deb-def5-2681c136cd03Product name320250325
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
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
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
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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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332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product 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
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e01133ad-4dcd-c7f3-454b-2ff569ee160aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-555-01Vicks NyQuil HOT REMEDYCold and Flu1 in 1 PACKETPOWDER, FOR SOLUTION11
58933-555-01Vicks DayQuil NyQuil HOT REMEDYCold and Flu1 in 1 PACKETPOWDER, FOR SOLUTION1650 mg1
58933-555-08Vicks NyQuil HOT REMEDYCold and Flu8 in 1 PACKAGEPOWDER, FOR SOLUTION81
58933-555-08Vicks NyQuil HOT REMEDYCold and Flu1 in 1 PACKETPOWDER, FOR SOLUTION11

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 1 of 195 · 3,890 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Daytime Nighttime Intense Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEWalgreen Company03aa43fd-4962-4c2c-9edd-e422a629a0e32026-08-06WarningsExact identifier
application number: M012
Allergy Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE AND PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEf311b56f-b959-4070-9b23-82c642dd98b82026-08-06WarningsExact identifier
application number: M012
Cold Relief Multi-SymptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLL.N.K. International, Inc.2ed25f69-89ef-4c50-946a-7e7b9df1ca8a2026-08-06WarningsExact identifier
application number: M012
EucamintMENTHOL, CAMPHORIndiana Botanic Gardensd79bc8de-9efb-4996-a55c-accda0f8edb22026-08-06WarningsExact identifier
application number: M012
DRX CHOICE Daytime and Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL, AND ACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATERaritan Pharmaceuticals Incb745f45d-2042-4daa-9932-241836d7734b2026-08-06WarningsExact identifier
application number: M012
Acetaminophen, Dextromethorphan HBrACETAMINOPHEN, DEXTROMETHORPHAN HBRNUVICARE LLC6713fdff-0e4e-4a9d-b218-34f786339c572026-08-06WarningsExact identifier
application number: M012
Daytime Cold, Nighttime Cold multi-symptomACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLUnited Natural Foods, Inc. dba UNFI3b462a5d-d48b-4b73-b5d4-d7944730bbdd2026-08-06WarningsExact identifier
application number: M012
Sinufrin Quick Relief DecongestantSINUFRINNeilmed pharmaceuticals Inc.0c36a34e-462d-713c-e063-6294a90a17762026-08-05WarningsExact identifier
application number: M012
No DripOXYMETAZOLINE HYDROCHLORIDENeilMed Pharmaceuticals Ince9b799ad-9164-7f30-e053-2a95a90a00c52026-08-05WarningsExact identifier
application number: M012
DM MaxDEXTROMETHORPHAN HBR, GUAIFENESINWalgreen Company78edeb7a-4712-4f04-9d76-d5b2d20ce76d2026-08-04WarningsExact identifier
application number: M012
CareOne Nighttime Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEAmerican Sales Companyc9342ad2-84dc-4f4c-9b05-c6e5c1c7989e2026-08-04WarningsExact identifier
application number: M012
dg health cold and flu reliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATEDolgencorp Inc3d8ce88e-9f40-4b58-a811-160ddbfb81122026-08-04WarningsExact identifier
application number: M012
ValuRx Dye Free Allergy ReliefDIPHENHYDRAMINE HCL 25 MGShield Pharmaceuticals Corpca60a413-b02e-48ce-985d-4d415780c6792026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLWal-Mart Stores Inc150b68ba-3ed4-4533-9118-74e76eaf6e482026-08-04WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HCLRite Aid Corporationce393bff-498b-42e6-a41c-bbfbc58fb42c2026-08-04WarningsExact identifier
application number: M012
Sinus and HeadacheACETAMINOPHEN AND PHENYLEPHRINE HCLCardinal Health 110, LLC. DBA Leader3b8662bf-3abb-4e54-af9c-5fa1d2e190032026-08-04WarningsExact identifier
application number: M012
Mucus Relief PEGUAIFENESIN, PHENYLEPHRINE HCLWalgreen Companycb1c1922-5dc6-520d-e77e-e951726d97012026-08-04WarningsExact identifier
application number: M012
Chest Congestion Relief DMDEXTROMETHORPHAN HBR, GUAIFENESINDOLGENCORP, LLCda053bc3-e790-4ae9-a406-2629640e97e72026-08-04WarningsExact identifier
application number: M012
Cold and Flu plus Congestion NighttimeACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLWALMART INC.1236b463-0073-44b5-a516-5b7c06a408872026-08-04WarningsExact identifier
application number: M012
daytime nitetime cold and fluACETAMINOPHEN, DEXTROMETHORPHAN HBR, DOXYLAMINE SUCCINATE, PHENYLEPHRINE HCLMeijer Distribution Inc80aae1c3-a616-442b-842e-177db957a69c2026-08-04WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2679426{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral Solution) } PackGPCK457180c9-87ea-5b52-e063-6294a90a7e9d1
26794261 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Granules for Oral Solution) PackPSN457180c9-87ea-5b52-e063-6294a90a7e9d1
2679420acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionPSN457180c9-87ea-5b52-e063-6294a90a7e9d1
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionPSN457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral SolutionPSN457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677acetaminophen 650 MG / diphenhydrAMINE HCl 25 MG Powder for Oral SolutionPSN4535d4fe-9de7-f2c6-e063-6394a90a944a1
2679425acetaminophen 650 MG / diphenhydrAMINE hydrochloride 25 MG Granules for Oral SolutionPSN457180c9-87ea-5b52-e063-6294a90a7e9d1
2679420acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionSCD457180c9-87ea-5b52-e063-6294a90a7e9d1
2670598acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSCD457180c9-87ea-5b52-e063-6294a90a7e9d1
2679425acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral SolutionSCD457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral SolutionSCD457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral SolutionSCD4535d4fe-9de7-f2c6-e063-6394a90a944a1
2679426{1 (acetaminophen 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral Solution) / 1 (acetaminophen 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral Solution) } PackSY457180c9-87ea-5b52-e063-6294a90a7e9d1
26794261 daytime (acetaminophen 500 MG / dextromethorphan HBr 20 MG Granules for Oral Solution) / 1 nighttime (acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral Solution) PackSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral SolutionSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677acetaminophen 650 MG / diphenhydramine HCl 25 MG Granules for Oral SolutionSY4535d4fe-9de7-f2c6-e063-6394a90a944a1
2670677acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral SolutionSY4535d4fe-9de7-f2c6-e063-6394a90a944a1
2670677acetaminophen 650 MG / diphenhydramine HCl 25 MG Packet for Oral SolutionSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2679420APAP 500 MG / dextromethorphan hydrobromide 20 MG Granules for Oral SolutionSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2670598APAP 500 MG / dextromethorphan hydrobromide 20 MG Powder for Oral SolutionSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2679425APAP 650 MG / diphenhydramine hydrochloride 25 MG Granules for Oral SolutionSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral SolutionSY457180c9-87ea-5b52-e063-6294a90a7e9d1
2670677APAP 650 MG / diphenhydramine hydrochloride 25 MG Powder for Oral SolutionSY4535d4fe-9de7-f2c6-e063-6394a90a944a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
58933-555-01589330555011 POWDER, FOR SOLUTION in 1 PACKET (58933-555-01) 2025-06-11NoNoCurrent