FDA.reportPublic FDA data

Fortify

Product NDC
69204-003
11-digit product format
692040003
Labeler code
69204
Product ID
69204-003_471f730a-d3c4-2428-e063-6294a90a14ed
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
OIL
Route
TOPICAL
Labeler
Natures Formulae Health Products Ltd.
Application
M012
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-16
Substance
MENTHOL
Active strength
24 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Fortify
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL24 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
L7T10EIP3AInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
781d53cf-b3dc-3e2b-e053-2a91aa0a7dcdAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69204-003-03Fortify1 in 1 BOXOIL12
69204-003-03Fortify30 mL in 1 BOTTLE, DROPPEROIL302
69204-003-04Fortify10 mL in 1 BOTTLE, DROPPEROIL102
69204-003-04Fortify1 in 1 BOXOIL12
69204-003-05Fortify6 mL in 1 BOTTLE, DROPPEROIL62
69204-003-05Fortify1 in 1 BOXOIL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69204-003FORTIFY (MENTHOL) OIL [NATURES FORMULAE HEALTH PRODUCTS LTD.]1Current NDC, Legacy NDC, 6 package rows20181014_781d53cf-b3dc-3e2b-e053-2a91aa0a7dcd.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 80 of 180 · 3,583 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
cherry throat relief lozengesBENZOCAINECintas Corporation49b25e9e-1d47-4a10-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
cherry sore throat lozengeBENZOCAINECVS Pharmacy3c54974d-9d15-2fa1-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
honey lemon sore throat lozengesBENZOCAINECVS Pharmacy3c55009c-4b3e-135e-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free menthol cough dropsMENTHOLCVS Pharmacy3bdd24a8-3b44-00cd-e054-00144ff8d46c2025-12-07WarningsExact identifier
application number: M012
sugar free honey lemon cough dropsMENTHOLCVS Pharmacy3c125b3a-e58f-5c06-e054-00144ff88e882025-12-07WarningsExact identifier
application number: M012
CVS Menthol Cough DropsMENTHOLCVS Pharmacyde97d13b-bb67-d0e6-e053-2995a90aeb2c2025-12-07WarningsExact identifier
application number: M012
menthol cough dropsMENTHOLAmerican Sales34dd34d1-1a08-3470-e054-00144ff8d46c2025-12-06WarningsExact identifier
application number: M012
DOLOGENACETAMINOPHEN, DEXBROMPHENIRAMINE MALEATEKramer Novis656ea9ba-c9cf-44c6-af40-b8ba292ce38a2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLCa79b5541-864b-412a-a085-96986ed6af592025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Extra MoisturizingOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.346f32cb-74cb-4896-b770-76d5f829a17d2025-12-05WarningsExact identifier
application number: M012
Afrin No Drip Original Pump MistOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.530b2d27-5883-489e-87fa-90b45eb93b3c2025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Cough and Cold Cough Suppressant, AntihistamineCHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN HYDROBROMIDEBayer HealthCare LLC.ee666963-e686-4374-b52b-a677f1cd41142025-12-05WarningsExact identifier
application number: M012
Afrin No-Drip Allergy SinusOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC3beb5839-7422-449d-e054-00144ff88e882025-12-05WarningsExact identifier
application number: M012
Coricidin HBP Nighttime Multi-Symptom ColdACETAMINOPHEN,DEXTROMETHORPHAN HYDROBROMIDE, DOXYLAMINE SUCCINATEBayer HealthCare LLC.513ca24f-1262-4a2d-e054-00144ff8d46c2025-12-05WarningsExact identifier
application number: M012
Afrin Severe CongestionOXYMETAZOLINE HYDROCHLORIDEBayer HealthCare LLC.a49a506e-aca2-4af0-a50b-dca2c031e61d2025-12-05WarningsExact identifier
application number: M012
Throat Coat Sweet Orange FennelMENTHOLTraditional Medicinals, Inc.a746cef4-1fb4-45cf-e053-2995a90a02c82025-12-05WarningsExact identifier
application number: M012
GuaifenesinGUAIFENESINHealth Pharma USA LLC31755594-3e1c-b290-e063-6394a90aba612025-12-05WarningsExact identifier
application number: M012
Tabcin Extra StrengthACETAMINOPHEN, CHLORPHENIRAMINE MALEATE, DEXTROMETHORPHAN HBR, PHENYLEPHRINE HCL,Pharmadel LLC0670c33e-8a3c-ae00-e063-6294a90a165b2025-12-05WarningsExact identifier
application number: M012
Severe Sinus Congestion and PainACETAMINOPHEN, GUAIFENESIN, PHENYLEPHRINEShield Pharmaceuticals Corpd0dd4a75-da65-4c66-b65f-54ee141008462025-12-05WarningsExact identifier
application number: M012
Basic Care Cherry Cough DropsMENTHOLAmazon.comc0588221-0c84-66d8-e053-2995a90a874f2025-12-05WarningsExact identifier
application number: M012

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69204-003-03692040003031 BOTTLE, DROPPER in 1 BOX (69204-003-03) / 30 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
69204-003-04692040003041 BOTTLE, DROPPER in 1 BOX (69204-003-04) / 10 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent
69204-003-05692040003051 BOTTLE, DROPPER in 1 BOX (69204-003-05) / 6 mL in 1 BOTTLE, DROPPER2016-10-160000-00-00NoNoCurrent