FDA.reportPublic FDA data

Cold Relief Syrup Kids Cherry

Product NDC
53499-1165
11-digit product format
534991165
Labeler code
53499
Product ID
53499-1165_d19eacff-a035-40ca-90a8-0d5885508a15
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
SYRUP
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]/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 Syrup Kids Cherry
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
d4203195-39fa-4329-96b1-180857d8a08fAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-1165-5Cold Relief Syrup Kids Cherry120 mL in 1 BOTTLE, PLASTICSYRUP1205
53499-1165-5Cold Relief Syrup Kids Cherry1 in 1 CARTONSYRUP15

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53499-1165-5ML - Milliliter53499-11656ec418d8-23cc-4da8-a2e2-9a126dbe120f12025-10-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-1165COLD RELIEF SYRUP KIDS CHERRY (PELARGONIUM SIDOIDES) SYRUP [SCHWABE NORTH AMERICA, INC]4Current NDC, 2 package rows20250309_d4203195-39fa-4329-96b1-180857d8a08f.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 Syrup Kids CherryPELARGONIUM SIDOIDESSchwabe North America, Incd4203195-39fa-4329-96b1-180857d8a08f2025-09-16WarningsExact identifier
ndc (product): 53499-1165

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-1165-5534991165051 BOTTLE, PLASTIC in 1 CARTON (53499-1165-5) / 120 mL in 1 BOTTLE, PLASTIC2023-07-11NoNoCurrent