FDA.reportPublic FDA data

Vicks VapoFreeze

Product NDC
84126-383
11-digit product format
841260383
Labeler code
84126
Product ID
84126-383_5d192f10-056a-e376-e063-6394a90a54e1
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
LIQUID
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-05-05
Substance
CAMPHOR (SYNTHETIC); LEVOMENTHOL
Active strength
3.6; 16 g/100g; g/100g
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 VapoFreeze
Brand name suffix
PAIN RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CAMPHOR (SYNTHETIC)3.6 g/100g
LEVOMENTHOL16 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-383-03Vicks VapoFreezePAIN RELIEF70.9 g in 1 BOTTLE, WITH APPLICATORLIQUID70.91

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 145 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AMINO ACTIVE Topical Analgesic CreamHISTAMINE DIHYDROCHLORIDEVIREO SYSTEMS, INC.591b1e7e-a8c0-4640-a592-4e0f3538a40e2023-11-11WarningsExact identifier
application number: M017
NERVE ACTIVE Pain Relief CreamMENTHOLTOP DOG DIRECT, LLCa8b85dcb-fd3e-4340-a945-609fc741443c2023-11-11WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine BackLIDOCAINEGeri-Gentle Corporatione4427928-c063-9ca6-e053-2995a90a1aa12023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch Arm and NeckMENTHOLGeri-Gentle Corporatione4429f70-667e-662b-e053-2a95a90a62ba2023-11-10WarningsExact identifier
application number: M017
GeriGentle FrostyHeat Pain Relief Patch BackMENTHOLGeri-Gentle Corporatione442b8ec-a3de-65e8-e053-2995a90af3ec2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.9f948fb4-4275-4a1f-83f8-cd708db4a2962023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF PAIN RELIEFMENTHOLBLUE SPRING WELLNESS, L.L.C.b4278b70-e9a6-4d1f-bbad-257fe437b86a2023-11-10WarningsExact identifier
application number: M017
BLUE SPRING Foot and Leg Comfort Cream with Pain ReliefMENTHOL, CAPSAICINBLUE SPRING WELLNESS, L.L.C.2f9cf514-48be-49ec-b424-0b228b4b874a2023-11-10WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.1231ddd2-7661-45b2-ab15-32f7fdc078a82023-11-10WarningsExact identifier
application number: M017
SUPER WHITE Stuff Pain ReliefMENTHOLBLUE SPRING WELLNESS, L.L.C.7779b26b-ae3b-4639-a6b0-826c7ab37a862023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsa898d2ef-5fa0-4144-8bb5-f6d5fc3ff0d42023-11-10WarningsExact identifier
application number: M017
SUPER BLUE STUFF Pain Relief CreamMENTHOLBLUE SPRING WELLNESS, L.L.C.066a2106-2e25-4df6-9a8d-4417ba1902052023-11-10WarningsExact identifier
application number: M017
INVIGO FLEX Pain Relief GelMENTHOLWYNNPHARM INC.909e1d8c-c517-4d6a-8682-894f042c00f82023-11-10WarningsExact identifier
application number: M017
ARNIMAX Penetrating Pain Relief GelMENTHOLWYNNPHARM INC.3a31f805-19c6-4036-a663-ebef9b2120072023-11-10WarningsExact identifier
application number: M017
KERA HCHYDROCORTISONEClinical Therapeutic Solutionsac215c8f-b224-480c-9295-3a34316293ba2023-11-10WarningsExact identifier
application number: M017
ALO THERAPEUTIC MASSAGE PAIN RELIEVINGMENTHOL, HISTAMINE DIHYDROCHLORIDETheraplex Solutionsda004500-5e48-487b-b96f-520a3094096c2023-11-10WarningsExact identifier
application number: M017
Osteo Bi-Flex JOINT HEALTH PAIN RELIEVINGMENTHOL, METHYL SALICYLATERexall Sundown, LLC55c55f1c-d2b3-6363-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017
NEUROFLEX Topical Pain Relieving LiquidCAMPHOR (SYNTHETIC), MENTHOLAlmark Products Inc6da3aa84-7a01-4041-8792-a4bbf49e6e4e2023-11-10WarningsExact identifier
application number: M017
SMOOTH GATOR 60-second Pain ReliefCAMPHOR (SYNTHETIC), MENTHOLSmooth Gator LLC3b74b542-202f-469e-8025-4372e95e6b012023-11-10WarningsExact identifier
application number: M017
Alo Therapeutic MassageMENTHOL, HISTAMINE DIHYDROCHLORIDECMI Therapy Solutions40f8b8d1-a20b-54b0-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683202camphor 3.6 % / menthol 16 % Topical SprayPSN526cdb40-aa65-4885-e063-6294a90afa0c1
2683202camphor 36 MG/ML / menthol 160 MG/ML Topical SpraySCD526cdb40-aa65-4885-e063-6294a90afa0c1
2683202camphor 3.6 % / menthol 16 % Topical SpraySY526cdb40-aa65-4885-e063-6294a90afa0c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-383-038412603830370.9 g in 1 BOTTLE, WITH APPLICATOR (84126-383-03) 70.9 g2026-05-05NoNoCurrent