FDA.reportPublic FDA data

Triflora

Product NDC
53499-7290
Requested package NDC
53499-7290-8
11-digit product format
534997290
Labeler code
53499
Product ID
53499-7290_be615942-cb86-4d3d-8177-efc815ac4ff8
Type
HUMAN OTC DRUG
Nonproprietary name
Urtica doicia, Rhus Toxicodendron, Ledum Palustre
Dosage form
GEL
Route
TOPICAL
Labeler
Schwabe North America, Inc
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-10-01
Substance
LEDUM PALUSTRE TWIG; TOXICODENDRON PUBESCENS LEAF; URTICA DIOICA
Active strength
2; 4; 1 [hp_X]/77g; [hp_X]/77g; [hp_X]/77g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Triflora
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
URTICA DIOICA2 [hp_X]/77g
TOXICODENDRON PUBESCENS LEAF4 [hp_X]/77g
LEDUM PALUSTRE TWIG1 [hp_X]/77g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
710FLW4U46Internal UNII lookup
6IO182RP7AInternal UNII lookup
877L01IZ0PInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0f7796ae-a20e-431f-bdec-bca7415b468fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53499-7290-4Triflora1 in 1 CARTONGEL15
53499-7290-4Triflora28 g in 1 TUBEGEL285
53499-7290-8Triflora77 g in 1 TUBEGEL775
53499-7290-8Triflora1 in 1 CARTONGEL15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53499-7290TRIFLORA (URTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRE) GEL [SCHWABE NORTH AMERICA, INC]4Current NDC, Legacy NDC, 4 package rows20241215_0f7796ae-a20e-431f-bdec-bca7415b468f.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
TrifloraURTICA DOICIA, RHUS TOXICODENDRON, LEDUM PALUSTRESchwabe North America, Inc0f7796ae-a20e-431f-bdec-bca7415b468f2025-11-18WarningsExact identifier
ndc (package): 53499-7290-8
ndc (product): 53499-7290
ndc11 (package): 53499729008

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53499-7290-8534997290081 TUBE in 1 CARTON (53499-7290-8) / 77 g in 1 TUBE1 tube2021-10-010000-00-00NoNoCurrent