FDA.reportPublic FDA data

Vicks

Product NDC
84126-320
11-digit product format
841260320
Labeler code
84126
Product ID
84126-320_5d1b801c-3aeb-f78b-e063-6294a90a7a1b
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
2025-06-01
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
Brand name suffix
Vapo Breathers
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
84126-320-40VicksVapo Breathers1 in 1 POUCHLOZENGE11
84126-320-40VicksVapo Breathers40 in 1 BAGLOZENGE401

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 27 of 40 · 786 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Primo Topical AnestheticBENZOCAINETri State Dentalf7862ee9-117a-493d-83ee-5aef588a86de2025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental011c6a04-a489-41a5-ad2f-8ec281e079332025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental45422b0f-f1ac-4bec-851a-c1394bc52fcc2025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLC043c336f-60e3-dc23-e063-6294a90a4b132025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCe67b8def-c728-4952-9b35-874643cbe0f12025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical AnestheticBENZOCAINEBeutlich Pharmaceuticals, LLCe628bd9f-99e5-4c71-ba8a-caa6c337de542025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCfef1f48c-e89d-4b75-9ba0-b1b068daf5822025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalb18c2bfc-638e-40a7-8ecb-60303aa3f5192025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental64b9ebe6-afbe-4db2-b4bf-14ff5d007ea02025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalf5d37a12-9db1-4f2c-9dd1-72a8361e0e572025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dentalcb25c40b-07ef-44b8-9f48-0b8f3f78c8822025-01-08WarningsExact identifier
application number: M022
Primo Topical AnestheticBENZOCAINETri State Dental3ad7867c-b584-4355-9fd7-7582919751bd2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsaaa7d4e2-9154-4c34-a1ec-d89231eda4472025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsc385cc66-7d08-4b63-bfba-a133b5275c6d2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsddc81125-e12b-4170-938d-df7a624a7dfd2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsaaa1390b-d060-43a4-87ee-1497fa82e21b2025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Productsc78b5f2b-4434-4f36-82e3-781409db41622025-01-08WarningsExact identifier
application number: M022
Advance Topical Anesthetic GelBENZOCAINEThe Atlanta Dental Supply Company DBA Advanced Dental Products4545ab53-aa2d-41c4-9395-50bb64c196632025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic GelBENZOCAINEBeutlich Pharmaceuticals, LLCc113773b-dfb0-4797-ae0e-ecc06bfffd682025-01-08WarningsExact identifier
application number: M022
HurriCaine Topical Anesthetic LiquidBENZOCAINEBeutlich Pharmaceuticals, LLC31232583-180c-43d1-bc45-c3f6d9ea50812025-01-08WarningsExact identifier
application number: M022

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1995300menthol 20 MG Oral LozengePSN365b3831-5d58-c607-e063-6294a90a39c91
1995300menthol 20 MG Oral LozengeSCD365b3831-5d58-c607-e063-6294a90a39c91

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
84126-320-408412603204040 POUCH in 1 BAG (84126-320-40) / 1 LOZENGE in 1 POUCH40 pouch2025-06-01NoNoCurrent