FDA.reportPublic FDA data

Vicks VapoCool

Product NDC
69423-796
11-digit product format
694230796
Labeler code
69423
Product ID
69423-796_5d18e3cc-6aca-6f8f-e063-6294a90a93ee
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
LOZENGE
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M022
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-07-13
Substance
MENTHOL
Active strength
20 mg/1
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
SEVERE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL20 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69423-796-05Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19
69423-796-05Vicks VapoCoolSEVERE225 in 1 BAGLOZENGE2259
69423-796-18Vicks VapoCoolSEVERE18 in 1 BAGLOZENGE189
69423-796-18Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19
69423-796-45Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19
69423-796-45Vicks VapoCoolSEVERE45 in 1 BAGLOZENGE459
69423-796-70Vicks VapoCoolSEVERE70 in 1 BAGLOZENGE709
69423-796-70Vicks VapoCoolSEVERE1 in 1 POUCHLOZENGE19

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69423-796VICKS VAPOCOOL SEVERE (MENTHOL) LOZENGE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, 8 package rows20250504_c77f8878-5eef-b006-e053-2a95a90a1866.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 40 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
IoliteBENZOCAINEDharma Research, Inc.e4b2d22b-00b3-45a6-9b7d-8ee7195870592023-10-09WarningsExact identifier
application number: M022
IoliteBENZOCAINEDharma Research, Inc.a0e284f6-292f-4231-8596-f7cee4e0a12f2023-10-09WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCfe92637a-c88a-f9dd-e053-6294a90a7fa32023-07-01WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCc979e958-2042-471a-bf03-e84e686201062023-06-20WarningsExact identifier
application number: M022
Orajel Gum Pain 3X MedicatedBENZOCAINE, MENTHOL, ZINC CHLORIDEChurch & Dwight Co., Inc.9a1632ad-2b47-5653-e053-2995a90ae0d92023-01-20WarningsExact identifier
application number: M022
KOLORZ TOPICAL ANESTHETIC TRIPLE MINTBENZOCAINEDMG AMERICA, LLC0f90b227-f938-4e1a-a79e-1967b1a0477e2021-10-01WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995300menthol 20 MG Oral LozengePSNc77f8878-5eef-b006-e053-2a95a90a18669
1995300menthol 20 MG Oral LozengeSCDc77f8878-5eef-b006-e053-2a95a90a18669

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69423-796-0569423079605225 POUCH in 1 BAG (69423-796-05) / 1 LOZENGE in 1 POUCH225 pouch2021-07-13NoNoCurrent
69423-796-186942307961818 POUCH in 1 BAG (69423-796-18) / 1 LOZENGE in 1 POUCH18 pouch2021-07-13NoNoCurrent
69423-796-456942307964545 POUCH in 1 BAG (69423-796-45) / 1 LOZENGE in 1 POUCH45 pouch2021-07-13NoNoCurrent
69423-796-706942307967070 POUCH in 1 BAG (69423-796-70) / 1 LOZENGE in 1 POUCH70 pouch2025-07-01NoNoCurrent