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 24 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc9315bd7c-44db-42c8-a9df-aaaa66153c172025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc56185c5f-6f6c-4976-bf18-540b076d90a62025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc88cadb9e-17ab-44bb-b4fe-fcfd6b7334652025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf71b0ab5-0605-4807-b835-903e19aaf2a82025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc37e2d51d-8526-4766-9f15-0ef4bc1f11552025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Inc1c0770a4-5a82-46d4-a660-7553632d749b2025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf1289991-c809-48cb-8bc1-724bc233dfe92025-01-09WarningsExact identifier
application number: M022
Astra-dent Topical Anesthetic GelBENZOCAINEZag Usa Incf2a3a496-c9e0-4eb1-94cc-4c6c5fd60fee2025-01-09WarningsExact identifier
application number: M022
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc6d8078e9-b0d8-4220-b90a-3f14fa0e43f42025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc26128466-939b-445f-aa64-04c7283d306c2025-01-09WarningsExact identifier
application number: M022
BurkhartSTANNOUS FLUORIDEBurkhart Dental Supply Inc048c9978-e32e-4f77-9a4e-40acd5fcdfaf2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa09dcc0-e641-4c6d-8a84-ba890c0fce4c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc4255da05-d264-4a4c-bd67-53d4862c06822025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc2282ea74-94c1-40be-a77f-290763a762502025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc99bce4c6-4593-40a1-b28d-8334a79b9d422025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incaa233c68-c6ac-44a5-b50e-3f5cd843bd252025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incbb11bfb4-1b50-48c6-8273-452b47b478332025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Inc867cef7b-fe6e-4a45-87c1-35579a681c6c2025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incc6238079-0bcc-4c35-9b73-455252d41ee52025-01-09WarningsExact identifier
application number: M022
Burkhart Topical AnestheticBENZOCAINEBurkhart Dental Supply Incb144aca9-91d1-4106-a39c-b928192ad41e2025-01-09WarningsExact 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