FDA.reportPublic FDA data

ORTHOGEL Menthol 3.5%

Product NDC
71726-007
11-digit product format
717260007
Labeler code
71726
Product ID
71726-007_cea6fae7-e526-454c-81a2-72dea124b5c2
Type
HUMAN OTC DRUG
Nonproprietary name
Menthol
Dosage form
GEL
Route
TOPICAL
Labeler
LiquidCapsule Manufacturing LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-06-06
Substance
MENTHOL
Active strength
3.5 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
ORTHOGEL Menthol 3.5%
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MENTHOL3.5 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiL7T10EIP3A
Rxcui808955

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71726-007-02ORTHOGEL Menthol 3.5%113.4 g in 1 TUBEGEL113.42
71726-007-03ORTHOGEL Menthol 3.5%113.4 g in 1 JARGEL113.42
71726-007-04ORTHOGEL Menthol 3.5%453.6 g in 1 BOTTLEGEL453.62
71726-007-05ORTHOGEL Menthol 3.5%907.2 g in 1 BOTTLEGEL907.22
71726-007-06ORTHOGEL Menthol 3.5%3580 g in 1 JUGGEL35802

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
808955menthol 3.5 % Topical GelPSN4fd4b7ac-1971-4abe-8fbb-74ab69e120612
808955menthol 0.035 MG/MG Topical GelSCD4fd4b7ac-1971-4abe-8fbb-74ab69e120612
808955menthol 3.5 % Topical GelSY4fd4b7ac-1971-4abe-8fbb-74ab69e120612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
71726-007-0271726000702113.4 g in 1 TUBE (71726-007-02) 113.4 g2025-06-06NoNoHistorical
71726-007-0371726000703113.4 g in 1 JAR (71726-007-03) 113.4 g2025-06-06NoNoHistorical
71726-007-0471726000704453.6 g in 1 BOTTLE (71726-007-04) 453.6 g2025-06-06NoNoHistorical
71726-007-0571726000705907.2 g in 1 BOTTLE (71726-007-05) 907.2 g2025-06-06NoNoHistorical
71726-007-06717260007063580 g in 1 JUG (71726-007-06) 3580 g2025-06-06NoNoHistorical