FDA.reportPublic FDA data

Vicks VapoCool

Product NDC
37000-928
11-digit product format
370000928
Labeler code
37000
Product ID
37000-928_5d2e1d79-d9d2-df18-e063-6394a90ac551
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine and Menthol
Dosage form
LIQUID
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-10-09
Substance
BENZOCAINE; MENTHOL
Active strength
5; 1 g/100mL; g/100mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [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 VapoCool
Brand name suffix
Sore Throat
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE5 g/100mL
MENTHOL1 g/100mL

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2021-02-12VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
2021-02-12VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
2021-02-12VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
2021-01-29VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
2021-01-29VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray
2021-01-29VICKS VAPOCOOL SORE THROAT BENZOCAINE & MENTHOL - ORAL ANESTHETICS Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-928-06Vicks VapoCoolSore Throat177 mL in 1 BOTTLE, PUMPLIQUID17710

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37000-928-06ML - Milliliter37000-9286b019a87-e4e9-43b9-9514-f231ee27c72312021-03-02

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-928VICKS VAPOCOOL SORE THROAT (BENZOCAINE AND MENTHOL) LIQUID [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, Legacy NDC, 1 package rows20241012_8749824b-6d04-430d-e053-2995a90a2db8.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 6 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AHLO PRO Healthy GumsCETYLPYRIDINIUM CHLORIDEGervest USA Inc4f5a0ccb-26e5-ebb6-e063-6394a90abbc52026-04-13WarningsExact identifier
application number: M022
Crest Scope Original Clean MintCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company4f1db6f4-acd7-a665-e063-6294a90a826b2026-04-10WarningsExact identifier
application number: M022
Sore ThroatPHENOL GLYCERINWalgreens1e845299-178e-49ce-9d08-7e9d548a5a6d2026-04-09WarningsExact identifier
application number: M022
Sore throat cherryPHENOLWalgreens67bed85e-e1e2-49ba-98d6-dfd4e1cd68562026-04-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.5eb437c5-a2af-4c0d-b7b9-9ab7d093db852026-04-06WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)269b9e7f-c5c8-4023-a3ea-e39040ade2712026-04-06WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c3fb6705-c647-4fe6-9aca-29735d01d8ea2026-04-02WarningsExact identifier
application number: M022
AntisepticEUCALYPTOL, MENTHOL, METHYL SALICYLATE, THYMOLFamily Dollar (FAMILY WELLNESS)f061ec82-7f0e-4b93-afa6-ae9fe14ab4ea2026-04-01WarningsExact identifier
application number: M022
CloSYS Silver Healthy GumsCETYLPYRIDINIUM CHLORIDERowpar Pharmaceuticals, Inc.11fd3f31-ee0c-43d2-a856-929d1298277c2026-04-01WarningsExact identifier
application number: M022
Crest Pro-Health Bold Fresh BreathCETYLPYRIDINIUM CHLORIDEThe Procter & Gamble Manufacturing Company5692c0ce-a914-08c4-e063-6394a90adf152026-04-01WarningsExact identifier
application number: M022
Anticavity FluorideSODIUM FLUORIDE AND ACIDULATED PHOSPHATEFamily Dollar (FAMILY WELLNESS)1666fff6-9a8b-40f9-ae53-914152db386b2026-04-01WarningsExact identifier
application number: M022
Sodium Chloride Normal SaltSODIUM CHLORIDETWIN MED LLC10230c8a-e5e5-44f1-b41d-80930899d6b92026-03-31WarningsExact identifier
application number: M022
Sootheez Birthday CakePECTINPrimrose Candy Co.4e5d8234-0521-0c8a-e063-6294a90ae62d2026-03-31WarningsExact identifier
application number: M022
Sootheez Watermelon MintPECTINPrimrose Candy Co.4e5e4342-4647-ef25-e063-6394a90a1d132026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC4e5a67a0-f989-50df-e063-6394a90aae732026-03-31WarningsExact identifier
application number: M022
PeriogelHYDROGEN PEROXIDEPERIO PROTECT, LLC1f9686b1-eac2-65b7-e063-6394a90a74fb2026-03-31WarningsExact identifier
application number: M022
PERIOGELXHYDROGEN PEROXIDEPERIO PROTECT, LLC1f7ecd75-bb59-2f4f-e063-6294a90ace842026-03-31WarningsExact identifier
application number: M022
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corped63df26-3879-46df-8e09-10be569b25be2026-03-31WarningsExact identifier
application number: M022
Benzocaine 20%BENZOCAINE 20%PAI Holdings, LLC dba PAI Pharma7fbce9a5-00dc-4a4a-8709-ab752bdf2f592026-03-25WarningsExact identifier
application number: M022
Kroger Extra WhiteningFLUORIDEKrogere704c690-1383-4cd6-be85-28bdd9ff936b2026-03-24WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2166147benzocaine 5 % / menthol 1 % Mucosal SprayPSN8749824b-6d04-430d-e053-2995a90a2db810
2166147benzocaine 50 MG/ML / menthol 10 MG/ML Mucosal SpraySCD8749824b-6d04-430d-e053-2995a90a2db810
2166147benzocaine 5 % / menthol 1 % Mucosal SpraySY8749824b-6d04-430d-e053-2995a90a2db810

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-928-0637000092806177 mL in 1 BOTTLE, PUMP (37000-928-06) 177 ml2019-10-090000-00-00NoNoCurrent