FDA.reportPublic FDA data

Vicks Formula 44

Product NDC
37000-997
11-digit product format
370000997
Labeler code
37000
Product ID
37000-997_5d1b858e-e23c-fab5-e063-6394a90a9148
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
2020-11-30
Substance
MENTHOL
Active strength
5.8 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 Formula 44
Brand name suffix
Cough Drops
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL5.8 mg/1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-997-50Vicks Formula 44Cough Drops50 in 1 BAGLOZENGE508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-997VICKS FORMULA 44 COUGH DROPS (MENTHOL) LOZENGE [THE PROCTER & GAMBLE MANUFACTURING COMPANY]6Current NDC, Legacy NDC, 1 package rows20241012_bb9e483e-095d-8a42-e053-2a95a90ad8d6.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 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
476973menthol 5.8 MG Oral LozengePSNbb9e483e-095d-8a42-e053-2a95a90ad8d68
476973menthol 5.8 MG Oral LozengeSCDbb9e483e-095d-8a42-e053-2a95a90ad8d68

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-997-503700009975050 LOZENGE in 1 BAG (37000-997-50) 50 lozenge2020-11-300000-00-00NoNoCurrent