Ferrum Metallicum

Product NDC
53645-1080
11-digit product format
536451080
Labeler code
53645
Product ID
53645-1080_2bafb2f6-d7e5-77da-e063-6294a90a2a64
Type
HUMAN OTC DRUG
Nonproprietary name
Ferrum Metallicum
Dosage form
CREAM
Route
TOPICAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-03-12
Substance
IRON
Active strength
6 [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 2 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct53645-1080UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53645-108053645-1080-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IRON6 [hp_X]/50mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
E1UOL152H7Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
88edb60a-96f9-4b90-854e-073f8f33ef97Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53645-1080-1Ferrum Metallicum50 mL in 1 JARCREAM503

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
IRONACTIVE INGREDIENTE1UOL152H7FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
IRONACTIVE MOIETYE1UOL152H7FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
GARCINIA INDICA SEED BUTTERINACTIVE INGREDIENTUS2H3D7800FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VFERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1080FERRUM METALLICUM CREAM [TRUE BOTANICA, LLC]3Current NDC, Legacy NDC, 1 package rows20250116_88edb60a-96f9-4b90-854e-073f8f33ef97.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
Ferrum MetallicumFERRUM METALLICUMTrue Botanica, LLC88edb60a-96f9-4b90-854e-073f8f33ef972025-01-14WarningsExact identifier
ndc (product): 53645-1080

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1080-15364510800150 mL in 1 JAR (53645-1080-1) 50 ml2013-03-120000-00-00NoNoCurrent