FDA.reportPublic FDA data

Vicks VapoCOOL

Product NDC
84126-341
11-digit product format
841260341
Labeler code
84126
Product ID
84126-341_5d1ae450-95c7-2a35-e063-6294a90a9187
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
2026-01-08
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
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
84126-341-12Vicks VapoCOOL12 in 1 PACKAGELOZENGE121
84126-341-12Vicks VapoCOOL1 in 1 POUCHLOZENGE11

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 28 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PureLife Topical AnestheticBENZOCAINEPureLife Dental4e68a4b9-a08c-4360-92b7-53d0f9df092d2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental103da78b-5de9-4fb4-9451-fd0269d296a52025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental833f0a44-dd32-4d5d-938d-fd56e7b23fcc2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental27772bcc-a338-4de4-8b16-cf647e4e08f62025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental9f2bdc10-6b41-4606-a65c-560d204fdb972025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dentalea8e5036-8c30-4527-9f0b-5c474bb0debd2025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dentalf9b9b085-ff61-4771-8d41-758bd061d9082025-01-08WarningsExact identifier
application number: M022
PureLife Topical AnestheticBENZOCAINEPureLife Dental8c2cec48-d19c-45b5-9f9a-c35358f369272025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.e629fbd0-7dc7-4c26-b221-6c5db80faa3c2025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.170ce528-7115-463c-b360-1d7a958bbd812025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.2a93e8fb-bb0d-4b0f-b5e7-ff1fe4ebb7982025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.c85e741b-da75-44ce-805e-5dde39795bd92025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.9fb0c45e-19b1-4b3b-adb7-e467bde03aa42025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentalc75195b6-f8b4-4fda-a162-5dd95bd9ab312025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dentalb6e25b54-4734-4769-9d1e-2d1187fdae192025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental1142e94e-0de1-4e8a-8eaf-a8dc0d08a2902025-01-08WarningsExact identifier
application number: M022
Health-Tec Topical AnestheticBENZOCAINEDental Health Products, Inc.9a9d71ff-121c-f6af-e053-2995a90ad27f2025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental4429a22e-2e3e-4519-b0a3-c1d86a62aba22025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental89b7e919-2656-4b1b-ab5c-5b11d42b52f32025-01-08WarningsExact identifier
application number: M022
BencoCaine Topical AnestheticBENZOCAINEBenco Dental05cf428c-3bc8-5fcb-e063-6394a90a962a2025-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995300menthol 20 MG Oral LozengePSN3de4268b-61a0-b92f-e063-6394a90a40b91
1995300menthol 20 MG Oral LozengeSCD3de4268b-61a0-b92f-e063-6394a90a40b91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-341-128412603411212 POUCH in 1 PACKAGE (84126-341-12) / 1 LOZENGE in 1 POUCH12 pouch2026-01-08NoNoCurrent