Arnica 6X

Product NDC
53645-1004
11-digit product format
536451004
Labeler code
53645
Product ID
53645-1004_1d5ff5bb-47b7-ebd1-e063-6394a90a84c9
Type
HUMAN OTC DRUG
Nonproprietary name
Arnica 6X
Dosage form
LIQUID
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-08-01
Substance
ARNICA MONTANA FLOWER; ARNICA MONTANA ROOT
Active strength
6; 6 [hp_X]/30mL; [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
Arnica 6X
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ARNICA MONTANA ROOT6 [hp_X]/30mL
ARNICA MONTANA FLOWER6 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MUE8Y11327Internal UNII lookup
OZ0E5Y15PZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1d5fd20f-00dc-c8fe-e063-6394a90afae7Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-1004-6Arnica 6X30 mL in 1 BOTTLELIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1004ARNICA 6X LIQUID [TRUE BOTANICA, LLC]1Current NDC, 1 package rows20240807_1d5fd20f-00dc-c8fe-e063-6394a90afae7.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
Arnica 6XARNICA 6XTrue Botanica, LLC1d5fd20f-00dc-c8fe-e063-6394a90afae72024-08-01WarningsExact identifier
ndc (product): 53645-1004

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53645-1004-65364510040630 mL in 1 BOTTLE (53645-1004-6) 30 ml2024-08-01NoNoCurrent