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 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
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