FDA.reportPublic FDA data

Rose Copper

Product NDC
48951-8348
Requested package NDC
48951-8348-5
11-digit product format
489518348
Labeler code
48951
Product ID
48951-8348_2b247a51-97b4-e240-e063-6294a90a8907
Type
HUMAN OTC DRUG
Nonproprietary name
Rose Copper
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Uriel Pharmacy Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2009-09-01
Substance
CUPROUS OXIDE
Active strength
1 [hp_X]/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rose CopperROSE COPPERUriel Pharmacy Inc.6749923f-e896-496f-a8ff-7cf7a386b5242025-01-07WarningsExact identifier
ndc (package): 48951-8348-5
ndc (product): 48951-8348
ndc11 (package): 48951834805

Additional Listing Data#

Finished product
Yes
Brand name base
Rose Copper
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CUPROUS OXIDE1 [hp_X]/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T8BEA5064FInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6749923f-e896-496f-a8ff-7cf7a386b524Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
48951-8348-5Rose Copper60 g in 1 TUBEOINTMENT607

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CUPRIC CATIONACTIVE INGREDIENT8CBV67279LROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1
CUPRIC CATIONACTIVE MOIETY8CBV67279LROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1
GERANIUM OIL, ALGERIAN TYPEINACTIVE INGREDIENT5Q1I94P4WGROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1
ROSE OILINACTIVE INGREDIENTWUB68Y35M7ROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4ROSE COPPER WARMING SUPPORT OINTMENT [URIEL PHARMACY INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
48951-8348ROSE COPPER OINTMENT [URIEL PHARMACY INC.]7Current NDC, Legacy NDC, 1 package rows20250109_6749923f-e896-496f-a8ff-7cf7a386b524.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
48951-8348-54895183480560 g in 1 TUBE (48951-8348-5) 60 g2009-09-010000-00-00NoNoCurrent