FDA.reportPublic FDA data

Cold Relief Drops

Product NDC
53499-8271
11-digit product format
534998271
Labeler code
53499
Product ID
53499-8271_4c467925-b572-4736-8f6c-07b3eab5522e
Type
HUMAN OTC DRUG
Nonproprietary name
Pelargonium sidoides
Dosage form
LIQUID
Route
ORAL
Labeler
Schwabe North America, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-08-26
Substance
PELARGONIUM SIDOIDES ROOT
Active strength
1 [hp_X]/30mL
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 Drops
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PELARGONIUM SIDOIDES ROOT1 [hp_X]/30mL

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
df3b5597-dc75-4736-be31-38f916414d76Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-8271-4Cold Relief Drops30 mL in 1 BOTTLE, DROPPERLIQUID302
53499-8271-4Cold Relief Drops1 in 1 CARTONLIQUID12
53499-8271-8Cold Relief Drops1 in 1 CARTONLIQUID12
53499-8271-8Cold Relief Drops59 mL in 1 BOTTLE, DROPPERLIQUID592

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-8271COLD RELIEF DROPS (PELARGONIUM SIDOIDES) LIQUID [SCHWABE NORTH AMERICA, INC.]1Current NDC, 4 package rows20240828_df3b5597-dc75-4736-be31-38f916414d76.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 DropsPELARGONIUM SIDOIDESSchwabe North America, Inc.df3b5597-dc75-4736-be31-38f916414d762025-09-17WarningsExact identifier
ndc (product): 53499-8271

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
53499-8271-4534998271041 BOTTLE, DROPPER in 1 CARTON (53499-8271-4) / 30 mL in 1 BOTTLE, DROPPER2024-08-26NoNoCurrent
53499-8271-8534998271081 BOTTLE, DROPPER in 1 CARTON (53499-8271-8) / 59 mL in 1 BOTTLE, DROPPER2024-08-26NoNoCurrent