FDA.reportPublic FDA data

Cold Relief Kids Cherry

Product NDC
53499-5522
11-digit product format
534995522
Labeler code
53499
Product ID
53499-5522_393748bc-de23-4580-9a85-ea008bebef2f
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2025-04-15
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/1
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 Kids Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/1

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
18168f3e-b214-494c-bacf-960247d09c49Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-5522-3Cold Relief Kids Cherry3 in 1 CARTONTABLET, CHEWABLE33
53499-5522-3Cold Relief Kids Cherry10 in 1 BLISTER PACKTABLET, CHEWABLE103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-5522COLD RELIEF KIDS CHERRY (PELARGONIUM SIDOIDES) TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC]3Current NDC, 2 package rows20250430_18168f3e-b214-494c-bacf-960247d09c49.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 Kids CherryPELARGONIUM SIDOIDESSchwabe North America, Inc18168f3e-b214-494c-bacf-960247d09c492025-04-29WarningsExact identifier
ndc (product): 53499-5522

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-5522-3534995522033 BLISTER PACK in 1 CARTON (53499-5522-3) / 10 TABLET, CHEWABLE in 1 BLISTER PACK3 blister pack2025-04-15NoNoCurrent