FDA.reportPublic FDA data

NyQuil Severe Plus VapoCOOL Cold and Flu

Product NDC
66715-9905
11-digit product format
667159905
Labeler code
66715
Product ID
66715-9905_06be9e28-b6c3-a4e4-e063-6294a90a3400
Type
HUMAN OTC DRUG
Nonproprietary name
Acetaminophen, Phenylephrine Hydrochloride, Doxylamine Succinate, and Dextromethorphan Hydrobromide
Dosage form
TABLET, COATED
Route
ORAL
Labeler
Lil' Drug Store Products, Inc.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-01
Substance
ACETAMINOPHEN; PHENYLEPHRINE HYDROCHLORIDE; DOXYLAMINE SUCCINATE; DEXTROMETHORPHAN HYDROBROMIDE
Active strength
325; 5; 6.25; 10 mg/1; mg/1; mg/1; mg/1
Pharmacologic classes
Adrenergic alpha1-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-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
NyQuil Severe Plus VapoCOOL Cold and Flu
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ACETAMINOPHEN325 mg/1
PHENYLEPHRINE HYDROCHLORIDE5 mg/1
DOXYLAMINE SUCCINATE6.25 mg/1
DEXTROMETHORPHAN HYDROBROMIDE10 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
V9BI9B5YI2Internal UNII lookup
362O9ITL9DInternal UNII lookup
9D2RTI9KYHInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1546881Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e7355543-6dd7-4560-8fe0-9c1ebd4d2c0bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
f4368033-af8c-41bf-a84b-ff77392b8522Product name120161229

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
66715-9905-2NyQuil Severe Plus VapoCOOL Cold and Flu2 in 1 POUCHTABLET, COATED27
66715-9905-2NyQuil Severe Plus VapoCOOL Cold and Flu2 in 1 CARTONTABLET, COATED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
66715-9905NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, CVP HEALTH (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED NYQUIL SEVERE PLUS VAPOCOOL COLD AND FLU, TRAVEL BASIX (ACETAMINOPHEN, PHENYLEPHRINE HYDROCHLORIDE, DOXYLAMINE SUCCINATE, AND DEXTROMETHORPHAN HYDROBROMIDE) TABLET, COATED [LIL' DRUG STORE PRODUCTS, INC.]7Current NDC, Legacy NDC, 2 package rows20231003_e7355543-6dd7-4560-8fe0-9c1ebd4d2c0b.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 76 of 178 · 3,551 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Good Sense Cherry Cough DropsMENTHOLGeiss, Destin, Dunnc72db7f0-9324-8ed2-e053-2995a90a98682025-12-12WarningsExact identifier
application number: M012
Good Sense Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunnc72e557f-0211-81b9-e053-2995a90a14372025-12-12WarningsExact identifier
application number: M012
Good Sense Cherry Benzocaine LozengesBENZOCAINEGeiss, Destin, Dunnc7404c94-09eb-5cc5-e053-2995a90af0212025-12-12WarningsExact identifier
application number: M012
Good Sense SF Honey Lemon Cough DropsMENTHOLGeiss, Destin, Dunne11ed21f-6ceb-5908-e053-2995a90aea462025-12-12WarningsExact identifier
application number: M012
Severe Congestion Relief Maximum Strength SinusACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINE HCLWal-Mart Stores Inc59918b8b-5c91-468f-834e-66020dc1ae122025-12-12WarningsExact identifier
application number: M012
Daytime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCLSALADO SALES INC.8f66f5bc-7c77-420b-9feb-911c980fbfdc2025-12-12WarningsExact identifier
application number: M012
Cold and FluACETAMINOPHEN, DEXTROMETHORPHAN HBR, GUAIFENESIN, PHENYLEPHRINE HCLWALMART INC.de55a9fd-53a2-4f3e-82b7-cabcbe287d462025-12-12WarningsExact identifier
application number: M012
Nighttime Cold and Flu ReliefACETAMINOPHEN, DEXTROMETHORPHAN HBR AND DOXYLAMINE SUCCINATESALADO SALES INC.cc73b668-cc6a-41d6-800a-4988c59c04492025-12-12WarningsExact identifier
application number: M012
Allergy ReliefCHLORPHENIRAMINE MALEATECHAIN DRUG MARKETING ASSOCIATION INC75269bcc-3bb2-49a0-8788-6b7da18796d32025-12-12WarningsExact identifier
application number: M012
Suphedrine PE Sinus plus AllergyCHLORPHENIRAMINE MALEATE, PHENYLEPHRINE HCLARMY AND AIR FORCE EXCHANGE SERVICEaffac07f-d645-4999-98ee-7467902f5adc2025-12-12WarningsExact identifier
application number: M012
Sinus Congestion and Pain Relief Non-DrowsyACETAMINOPHEN, PHENYLEPHRINE HCLWinCo Foods, LLCf7e925f4-7da6-4157-a97f-e6a3e399911f2025-12-11WarningsExact identifier
application number: M012
Sinus Relief Severe Congestion and PainACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDECARDINAL HEALTH645f8075-e33f-4e1a-9249-7368261cdcb92025-12-11WarningsExact identifier
application number: M012
Geri-TussinGUAIFENESINGeri-Care Pharmaceuticals, Corp8fd0071b-c6ca-49e6-b159-45dead71b6642025-12-11WarningsExact identifier
application number: M012
Geri-Tussin DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp098582dc-3e12-782f-e063-6394a90aa1a12025-12-11WarningsExact identifier
application number: M012
GUAIASORB DMDEXTROMETHORPHAN HBR, GUAIFENESINGeri-Care Pharmaceuticals, Corp09866b9c-aa32-45eb-e063-6394a90a49032025-12-11WarningsExact identifier
application number: M012
Allergy ReliefDIPHENHYDRAMINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYd6947661-a6dd-4bc4-a0ca-932db1840f582025-12-11WarningsExact identifier
application number: M012
Mucus Relief Sinus Severe Congestion ReliefACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY2e751d67-51b4-4b74-a9e8-7f3bc56369842025-12-11WarningsExact identifier
application number: M012
Pressure and Pain Plus Mucus PEACETAMINOPHEN, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY232acb86-7383-4992-b333-1e47bf7c06ad2025-12-11WarningsExact identifier
application number: M012
Sinus Pressure plus Pain PEACETAMINOPHEN AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANY72847721-9f59-4af1-8f20-dc84497429182025-12-11WarningsExact identifier
application number: M012
Cold plus Flu SevereACETAMINOPHEN, DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, AND PHENYLEPHRINE HYDROCHLORIDEVALU MERCHANDISERS COMPANYf6401317-0295-14b3-e053-2a95a90acbb42025-12-11WarningsExact identifier
application number: M012

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1546881acetaminophen 325 MG / dextromethorphan HBr 10 MG / doxylamine succinate 6.25 MG / phenylephrine HCl 5 MG Oral TabletPSNe7355543-6dd7-4560-8fe0-9c1ebd4d2c0b7
1546881acetaminophen 325 MG / dextromethorphan hydrobromide 10 MG / doxylamine succinate 6.25 MG / phenylephrine hydrochloride 5 MG Oral TabletSCDe7355543-6dd7-4560-8fe0-9c1ebd4d2c0b7
1546881APAP 325 MG / Dextromethorphan Hydrobromide 10 MG / doxylamine succinate 6.25 MG / Phenylephrine Hydrochloride 5 MG Oral TabletSYe7355543-6dd7-4560-8fe0-9c1ebd4d2c0b7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
66715-9905-2667159905022 POUCH in 1 CARTON (66715-9905-2) / 2 TABLET, COATED in 1 POUCH2 pouch2019-05-010000-00-00NoNoCurrent