FDA.reportPublic FDA data

Cuprum Metallicum

Product NDC
53645-1050
11-digit product format
536451050
Labeler code
53645
Product ID
53645-1050_9c9e61ed-e8a4-e2bf-e053-2995a90a4e1f
Type
HUMAN OTC DRUG
Nonproprietary name
Cuprum Metallicum
Dosage form
CREAM
Route
TOPICAL
Labeler
True Botanica, LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-02-27
Marketing end
0000-00-00
Substance
COPPER
Active strength
6 [hp_X]/50mL
NDC exclude flag
No
Listing certified through
2021-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

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

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct53645-1050DDiscontinued by firm2026-08-17
excluded packagepackage53645-105053645-1050-1DDiscontinued by firm2026-08-17

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 productproduct53645-1050UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage53645-105053645-1050-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
COPPERACTIVE INGREDIENT789U1901C5CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
COPPERACTIVE MOIETY789U1901C5CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
.ALPHA.-TOCOPHEROLINACTIVE INGREDIENTH4N855PNZ1CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
ALMOND OILINACTIVE INGREDIENT66YXD4DKO9CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
GARCINIA INDICA SEED BUTTERINACTIVE INGREDIENTUS2H3D7800CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
JOJOBA OILINACTIVE INGREDIENT724GKU717MCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
LAVENDER OILINACTIVE INGREDIENTZBP1YXW0H8CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4MCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
POTASSIUM SORBATEINACTIVE INGREDIENT1VPU26JZZ4CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
WATERINACTIVE INGREDIENT059QF0KO0RCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1
YELLOW WAXINACTIVE INGREDIENT2ZA36H0S2VCUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53645-1050CUPRUM METALLICUM CREAM [TRUE BOTANICA, LLC]3Legacy NDC20250116_24bcbb19-cd20-40ab-b9a3-0b32fadf661d.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53645-1050-15364510500150 mL in 1 JAR (53645-1050-1) 50 ml2013-02-270000-00-00NoNoCurrent