FDA.reportPublic FDA data

Betula Radix 6X

Product NDC
53645-2250
11-digit product format
536452250
Labeler code
53645
Product ID
53645-2250_05519041-c819-db46-e063-6394a90acd25
Type
HUMAN OTC DRUG
Nonproprietary name
Betula Radix 6X
Dosage form
LIQUID
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-09-14
Substance
BETULA PAPYRIFERA WHOLE
Active strength
6 [hp_X]/30mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Betula Radix 6X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BETULA PAPYRIFERA WHOLE6 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SL7A75J492Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
05519c1a-7cde-6383-e063-6294a90a8d2dAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-2250-6Betula Radix 6X30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-2250BETULA RADIX 6X LIQUID [TRUE BOTANICA, LLC]1Current NDC, 1 package rows20230916_05519c1a-7cde-6383-e063-6294a90a8d2d.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
Betula Radix 6XBETULA RADIX 6XTrue Botanica, LLC05519c1a-7cde-6383-e063-6294a90a8d2d2023-09-14WarningsExact identifier
ndc (product): 53645-2250

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53645-2250-65364522500630 mL in 1 BOTTLE (53645-2250-6) 30 ml2023-09-14NoNoCurrent