FDA.reportPublic FDA data

Cold Relief Kids Cherry

Product NDC
53499-3351
11-digit product format
534993351
Labeler code
53499
Product ID
53499-3351_2c3a6c88-5af2-48cf-8dc4-9813fbfe1472
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
2023-07-11
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
fa739686-c938-4173-a001-cb39fc4db442Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-3351-0Cold Relief Kids Cherry10 in 1 BLISTER PACKTABLET, CHEWABLE105
53499-3351-0Cold Relief Kids Cherry1 in 1 CARTONTABLET, CHEWABLE15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-3351-0EA - Each53499-33518a5be3fd-1aab-429a-820e-2338f4ce73f512025-09-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-3351COLD RELIEF KIDS CHERRY (PELARGONIUM SIDOIDES) TABLET, CHEWABLE [SCHWABE NORTH AMERICA, INC]4Current NDC, 2 package rows20250129_fa739686-c938-4173-a001-cb39fc4db442.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, Incfa739686-c938-4173-a001-cb39fc4db4422025-08-28WarningsExact identifier
ndc (product): 53499-3351

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53499-3351-0534993351001 BLISTER PACK in 1 CARTON (53499-3351-0) / 10 TABLET, CHEWABLE in 1 BLISTER PACK1 blister pack2023-07-11NoNoCurrent