FDA.reportPublic FDA data

Rescue Remedy Kids

Product NDC
57687-334
11-digit product format
576870334
Labeler code
57687
Product ID
57687-334_4cd8690b-3962-b64d-e063-6294a90a2230
Type
HUMAN OTC DRUG
Nonproprietary name
Rescue Remedy
Dosage form
SPRAY
Route
ORAL
Labeler
Nelson Bach USA Limited
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-09-03
Marketing end
2027-08-31
Substance
CLEMATIS VITALBA FLOWER; HELIANTHEMUM NUMMULARIUM FLOWER; IMPATIENS GLANDULIFERA FLOWER; ORNITHOGALUM UMBELLATUM FLOWERING TOP; PRUNUS CERASIFERA FLOWER
Active strength
5; 5; 5; 5; 5 [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL; [hp_X]/.095mL
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Rescue Remedy Kids

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CLEMATIS VITALBA FLOWER5 [hp_X]/.095mL
HELIANTHEMUM NUMMULARIUM FLOWER5 [hp_X]/.095mL
IMPATIENS GLANDULIFERA FLOWER5 [hp_X]/.095mL
ORNITHOGALUM UMBELLATUM FLOWERING TOP5 [hp_X]/.095mL
PRUNUS CERASIFERA FLOWER5 [hp_X]/.095mL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57687-334-20Rescue Remedy Kids1 in 1 CARTONSPRAY11
57687-334-20Rescue Remedy Kids20 mL in 1 BOTTLE, SPRAYSPRAY201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57687-334RESCUE REMEDY KIDS (RESCUE REMEDY) SPRAY [NELSON BACH USA LIMITED]1Current NDC, 2 package rows20240905_1bb4654f-3470-7eb2-e063-6394a90a9be0.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
57687-334-20576870334201 BOTTLE, SPRAY in 1 CARTON (57687-334-20) / 20 mL in 1 BOTTLE, SPRAY2024-09-032027-08-31NoNoHistorical