FDA.reportPublic FDA data

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 UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
H6J53HEX8EInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c325ede-cc55-4e07-a8d1-d1acfb3c885fAvailable on FDA.report

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

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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cold Relief MentholPELARGONIUM SIDOIDESSchwabe North America, Inc3c325ede-cc55-4e07-a8d1-d1acfb3c885f2025-09-09WarningsExact identifier
ndc (product): 53499-6272

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