FDA.reportPublic FDA data

Sports For Trauma

Product NDC
53499-6492
11-digit product format
534996492
Labeler code
53499
Product ID
53499-6492_120be17f-c409-4543-a983-23284d1a7c67
Type
HUMAN OTC DRUG
Nonproprietary name
Bellis Perennis, Hypericum Perfomatum,Toxicodendron Pubscens Leaf, Ruta Graveolens Flowering Top
Dosage form
GEL
Route
TOPICAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-09-03
Substance
BELLIS PERENNIS; HYPERICUM PERFORATUM; RUTA GRAVEOLENS FLOWERING TOP; TOXICODENDRON PUBESCENS LEAF
Active strength
1; 2; 1; 4 [hp_X]/70g; [hp_X]/70g; [hp_X]/70g; [hp_X]/70g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sports For Trauma
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BELLIS PERENNIS1 [hp_X]/70g
HYPERICUM PERFORATUM2 [hp_X]/70g
RUTA GRAVEOLENS FLOWERING TOP1 [hp_X]/70g
TOXICODENDRON PUBESCENS LEAF4 [hp_X]/70g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2HU33I03UY, XK4IUX8MNB, N94C2U587S, 6IO182RP7A

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-6492-8Sports For Trauma1 in 1 CARTONGEL15
53499-6492-8Sports For Trauma70 g in 1 TUBEGEL705

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-6492SPORTS FOR TRAUMA (BELLIS PERENNIS, HYPERICUM PERFOMATUM,TOXICODENDRON PUBSCENS LEAF, RUTA GRAVEOLENS FLOWERING TOP) GEL [SCHWABE NORTH AMERICA, INC]4Current NDC, Legacy NDC, 2 package rows20241206_8483065f-9856-4885-b160-bda326acb335.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-6492-8534996492081 TUBE in 1 CARTON (53499-6492-8) / 70 g in 1 TUBE1 tube2021-09-030000-00-00NoNoCurrent