FDA.reportPublic FDA data

Vicks VapoCOOL

Product NDC
37000-597
11-digit product format
370000597
Labeler code
37000
Product ID
37000-597_401edda2-a00f-26d0-e063-6294a90afcc8
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
2017-12-29
Substance
MENTHOL
Active strength
20 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Vicks VapoCOOL
Brand name suffix
Severe WINTERFROST
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL20 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui1995300

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-597-18Vicks VapoCOOLSevere WINTERFROST1 in 1 POUCHLOZENGE15
37000-597-18Vicks VapoCOOLSevere WINTERFROST18 in 1 BAGLOZENGE185
37000-597-20Vicks VapoCOOLSevere WINTERFROST1 in 1 POUCHLOZENGE15
37000-597-20Vicks VapoCOOLSevere WINTERFROST200 in 1 BAGLOZENGE2005
37000-597-45Vicks VapoCOOLSevere WINTERFROST1 in 1 POUCHLOZENGE15
37000-597-45Vicks VapoCOOLSevere WINTERFROST45 in 1 BAGLOZENGE455
37000-597-70Vicks VapoCOOLSevere WINTERFROST1 in 1 POUCHLOZENGE15
37000-597-70Vicks VapoCOOLSevere WINTERFROST70 in 1 BAGLOZENGE705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-597VICKS VAPOCOOL SEVERE WINTERFROST (MENTHOL) LOZENGE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]3Current NDC, 8 package rows20241011_06579fc7-7d91-2a7b-e063-6394a90ae516.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995300menthol 20 MG Oral LozengePSN06579fc7-7d91-2a7b-e063-6394a90ae5165
1995300menthol 20 MG Oral LozengeSCD06579fc7-7d91-2a7b-e063-6394a90ae5165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37000-597-183700005971818 POUCH in 1 BAG (37000-597-18) / 1 LOZENGE in 1 POUCH18 pouch2017-12-29NoNoHistorical
37000-597-2037000059720200 POUCH in 1 BAG (37000-597-20) / 1 LOZENGE in 1 POUCH200 pouch2019-07-09NoNoHistorical
37000-597-453700005974545 POUCH in 1 BAG (37000-597-45) / 1 LOZENGE in 1 POUCH45 pouch2017-12-29NoNoHistorical
37000-597-703700005977070 POUCH in 1 BAG (37000-597-70) / 1 LOZENGE in 1 POUCH70 pouch2025-05-12NoNoHistorical