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 Identifiers#

Field, Values table
FieldValues
UniiH6J53HEX8E

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

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, DROPPER2024-08-26NoNoHistorical
53499-8271-8534998271081 BOTTLE, DROPPER in 1 CARTON (53499-8271-8) / 59 mL in 1 BOTTLE, DROPPER2024-08-26NoNoHistorical