FDA.reportPublic FDA data

Vicks VapoFreeze

Product NDC
84126-303
11-digit product format
841260303
Labeler code
84126
Product ID
84126-303_5d192993-2a3d-c526-e063-6294a90a7f3e
Type
HUMAN OTC DRUG
Nonproprietary name
Camphor, Menthol
Dosage form
SPRAY
Route
TOPICAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-05-21
Substance
MENTHOL; CAMPHOR (SYNTHETIC)
Active strength
.16; .036 g/g; g/g
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 RELIEVING
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL.16 g/g
CAMPHOR (SYNTHETIC).036 g/g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84126-303-03Vicks VapoFreezePAIN RELIEVING85 g in 1 BOTTLE, SPRAYSPRAY854

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84126-303VICKS VAPOFREEZE PAIN RELIEVING (CAMPHOR, MENTHOL) SPRAY [THE PROCTER & GAMBLE MANUFACTURING COMPANY]1Current NDC, 1 package rows20240525_4038e50d-b53b-4f56-b54e-62157e286e08.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 125 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
equaline anti itch maximum strengthHYDROCORTISONEUnited Natural Foods, Inc. dba UNFI070000d7-7d4d-439b-9a91-851ba7c027e62024-10-03WarningsExact identifier
application number: M017
hydrocortisone anti itchHYDROCORTISONEH E Ba1a9fed8-4938-48b5-81f1-d3942d534bb82024-10-03WarningsExact identifier
application number: M017
equaline anti itchHYDROCORTISONEUnited Natural Foods, Inc. dba UNFIef9ea069-9b97-4bf5-aaac-deb85334dbd02024-10-03WarningsExact identifier
application number: M017
Basic Care HydrocortisoneHYDROCORTISONEAmazon.com Services LLC7fa13ab4-5f2d-4a48-816f-1b22d5f757b22024-10-03WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEA-S Medication Solutionsdc388dc1-0c4f-4bf1-8a12-fa39892317bc2024-10-02WarningsExact identifier
application number: M017
Geliga MuscularMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAfb2beb08-0ad6-a89d-e053-6294a90aa6fe2024-10-02WarningsExact identifier
application number: M017
Geliga Muscular BalmMENTHOL, METHYL SALICYLATEPT. EAGLE INDO PHARMAda28097f-4b5c-6159-e053-2a95a90a7d962024-10-02WarningsExact identifier
application number: M017
CircatrixCAPSAICINPureTek Corporationcd3b1256-2df8-dc26-e053-2a95a90ad0492024-10-02WarningsExact identifier
application number: M017
DermacinRx Penetral CreamCAPSAICINPureTek Corporation1e343a52-6071-3230-e054-00144ff8d46c2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEBorden Company (Private) Limited36abfc2c-d424-4df8-968d-866342c96a562024-10-02WarningsExact identifier
application number: M017
Eagle BalmCAMPHOR MENTHOLEagle Indo Pharma, PT87614869-9675-2c76-e053-2a95a90a48a92024-10-02WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEBorden Company (Private) Limitedd9a93daa-4e24-6690-e053-2a95a90a147c2024-10-02WarningsExact identifier
application number: M017
Eagle Extra StrengthMENTHOL METHYL SALICYLATEBorden Company (Private) Limited5e02fbe3-5bc7-430e-b661-3a760ddd8fe02024-10-02WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEBorden Company (Private) Limitedc62a4313-2c07-5f58-e053-2995a90a083a2024-10-02WarningsExact identifier
application number: M017
Eagle Medicated AromaticCAMPHOR MENTHOL METHYL SALICYLATEEagle Indo Pharma, PTe272ec90-3cd9-5b70-e053-2a95a90a1df42024-10-02WarningsExact identifier
application number: M017
RUGBY HYDROCORTISONE WITH ALOEHYDROCORTISONEA-S Medication Solutionsb2674075-aaa4-4c77-bcaa-a76336b3c3212024-10-02WarningsExact identifier
application number: M017
Herb Street Anti-Itch StickHYDROCORTISONEBalassa Laboratories Inc.8717faae-59c3-4c6f-9ef1-285c0d2445ed2024-10-01WarningsExact identifier
application number: M017
Herb Street Backache and Sore Muscle ReliefMENTHOLBalassa Laboratories Inc.aeac1b64-8689-4b3d-a41c-db41061257b52024-10-01WarningsExact identifier
application number: M017
Herb Street Arthritis ReliefMENTHOL/CAMPHORBalassa Laboratories Inc.a9d8ceb7-def0-415f-8fc1-ff8dd3e418552024-10-01WarningsExact identifier
application number: M017
Lido King Lidocaine 4% Pain Relieving Gel-PatchLIDOCAINEGalaxy Bio, Inc.2243734a-4ea2-a5e5-e063-6294a90aba152024-10-01WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2683202camphor 3.6 % / menthol 16 % Topical SprayPSN4038e50d-b53b-4f56-b54e-62157e286e084
2683202camphor 36 MG/ML / menthol 160 MG/ML Topical SpraySCD4038e50d-b53b-4f56-b54e-62157e286e084
2683202camphor 3.6 % / menthol 16 % Topical SpraySY4038e50d-b53b-4f56-b54e-62157e286e084

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-303-038412603030385 g in 1 BOTTLE, SPRAY (84126-303-03) 85 g2024-05-21NoNoCurrent