FDA.reportPublic FDA data

dermveda ULTRA BALANITIS RELIEF

Product NDC
83819-987
Requested package NDC
83819-987-02
11-digit product format
838190987
Labeler code
83819
Product ID
83819-987_7659bda6-ed60-4559-a80a-96d5d030fd1d
Type
HUMAN OTC DRUG
Nonproprietary name
Cardiospermum, Curcuma Longa
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Celcius Corp.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-08-11
Substance
CARDIOSPERMUM HALICACABUM FLOWERING TOP; TURMERIC
Active strength
10; 10 [hp_X]/60mL; [hp_C]/60mL
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
dermveda ULTRA BALANITIS RELIEF
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
CARDIOSPERMUM HALICACABUM FLOWERING TOP10 [hp_X]/60mL
TURMERIC10 [hp_C]/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
MZP2508BRRInternal UNII lookup
856YO1Z64FInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ab44b4af-f712-411e-9c2a-92fedb931ef2Available 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
dermveda ULTRA BALANITIS RELIEFCARDIOSPERMUM, CURCUMA LONGACelcius Corp.ab44b4af-f712-411e-9c2a-92fedb931ef22026-08-11WarningsExact identifier
ndc (package): 83819-987-02
ndc (product): 83819-987
ndc11 (package): 83819098702

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83819-987-028381909870260 mL in 1 JAR (83819-987-02) 60 ml2026-08-11NoNoCurrent