FDA.reportPublic FDA data

Umcka Menthol

Product NDC
53499-5272
11-digit product format
534995272
Labeler code
53499
Product ID
53499-5272_85ee5b28-643c-448d-ad9e-961f27b2622e
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2006-01-01
Marketing end
2027-07-31
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/120mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Umcka Menthol

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/120mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiH6J53HEX8E

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5272-5Umcka Menthol120 mL in 1 BOTTLE, PLASTICSYRUP12012
53499-5272-5Umcka Menthol1 in 1 CARTONSYRUP112
53499-5272-9Umcka Menthol240 mL in 1 BOTTLE, PLASTICSYRUP24012
53499-5272-9Umcka Menthol1 in 1 CARTONSYRUP112

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-5272-5ML - Milliliter53499-52724aa4d383-3cc2-4df3-baf9-8d90618c99fa12025-05-14
53499-5272-9ML - Milliliter53499-52725f5ba943-dd56-4178-b8e3-3e418a334ded12025-10-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PELARGONIUM SIDOIDES ROOTACTIVE INGREDIENTH6J53HEX8EUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
PELARGONIUM SIDOIDES ROOTACTIVE MOIETYH6J53HEX8EUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
FRUCTOSEINACTIVE INGREDIENT6YSS42VSEVUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RUMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [NATURE'S WAY PRODUCTS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5272UMCKA MENTHOL (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]11Current NDC, Legacy NDC, 4 package rows20241017_a3d94c70-3d62-44a8-bdae-39b07e8e0e36.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
53499-5272-5534995272051 BOTTLE, PLASTIC in 1 CARTON (53499-5272-5) / 120 mL in 1 BOTTLE, PLASTIC2006-01-012027-07-31NoNoCurrent
53499-5272-9534995272091 BOTTLE, PLASTIC in 1 CARTON (53499-5272-9) / 240 mL in 1 BOTTLE, PLASTIC2006-01-012027-07-31NoNoCurrent