Cold Relief Menthol

Product NDC
53499-6272
11-digit product format
534996272
Labeler code
53499
Product ID
53499-6272_2bd3b9bc-b446-40ca-9920-b82e7c54604e
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-01-17
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/120mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Cold Relief Menthol
Listing expiration
2026-12-31

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
53499-6272-5Cold Relief Menthol120 mL in 1 BOTTLE, PLASTICSYRUP1202
53499-6272-5Cold Relief Menthol1 in 1 CARTONSYRUP12
53499-6272-9Cold Relief Menthol240 mL in 1 BOTTLE, PLASTICSYRUP2402
53499-6272-9Cold Relief Menthol1 in 1 CARTONSYRUP12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6272COLD RELIEF MENTHOL (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]1Current NDC, 4 package rows20250119_3c325ede-cc55-4e07-a8d1-d1acfb3c885f.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-6272-5534996272051 BOTTLE, PLASTIC in 1 CARTON (53499-6272-5) / 120 mL in 1 BOTTLE, PLASTIC2025-01-17NoNoCurrent
53499-6272-9534996272091 BOTTLE, PLASTIC in 1 CARTON (53499-6272-9) / 240 mL in 1 BOTTLE, PLASTIC2025-01-17NoNoCurrent