FDA.reportPublic FDA data

Aurum Pentas

Product NDC
53645-2630
Requested package NDC
53645-2630-6
11-digit product format
536452630
Labeler code
53645
Product ID
53645-2630_561c2e0e-e3b8-9b21-e063-6294a90a2ad6
Type
HUMAN OTC DRUG
Nonproprietary name
Aurum Metallicum 7X, 11X, 18X, 30X
Dosage form
LIQUID
Route
ORAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-07-08
Substance
GOLD
Active strength
7 [hp_X]/30mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
Aurum Pentas
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
GOLD7 [hp_X]/30mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
79Y1949PYOInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
561c328f-ff48-a032-e063-6294a90a437cAvailable on FDA.report

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
Aurum PentasAURUM METALLICUM 7X, 11X, 18X, 30XTrue Botanica, LLC561c328f-ff48-a032-e063-6294a90a437c2026-07-08WarningsExact identifier
ndc (package): 53645-2630-6
ndc (product): 53645-2630
ndc11 (package): 53645263006

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
53645-2630-65364526300630 mL in 1 BOTTLE (53645-2630-6) 30 ml2026-07-08NoNoCurrent