FDA.reportPublic FDA data

Renal Health Formula

Product NDC
83027-0102
11-digit product format
830270102
Labeler code
83027
Product ID
83027-0102_1a3a8aaf-710c-4882-b894-8f6e895db7bd
Type
HUMAN OTC DRUG
Nonproprietary name
Sarsaparilla (Smilax Regelii), Berberis Vulgaris, Leonurus Cardiaca, Lycopodium Clavatum, Nitricum Acidum, Digitalis Purpurea, Oxalicum Acidum, Uricum Acidum
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-08-23
Substance
BERBERIS VULGARIS ROOT BARK; DIGITALIS; LEONURUS CARDIACA WHOLE; LYCOPODIUM CLAVATUM SPORE; NITRIC ACID; OXALIC ACID DIHYDRATE; SMILAX ORNATA ROOT; URIC ACID
Active strength
6; 12; 6; 6; 6; 30; 4; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Renal Health Formula
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SMILAX ORNATA ROOT4 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK6 [hp_X]/mL
LEONURUS CARDIACA WHOLE6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
NITRIC ACID6 [hp_X]/mL
DIGITALIS12 [hp_X]/mL
OXALIC ACID DIHYDRATE30 [hp_X]/mL
URIC ACID30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 8 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2H1576D5WGInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
8NC0C2YXK0Internal UNII lookup
C88X29Y479Internal UNII lookup
411VRN1TV4Internal UNII lookup
F1T8QT9U8BInternal UNII lookup
0K2L2IJ59OInternal UNII lookup
268B43MJ25Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bc92de6c-f35a-49e8-9540-749197aebdbaAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0102-1Renal Health Formula60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0102RENAL HEALTH FORMULA (SARSAPARILLA (SMILAX REGELII), BERBERIS VULGARIS, LEONURUS CARDIACA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, DIGITALIS PURPUREA, OXALICUM ACIDUM, URICUM ACIDUM) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230824_bc92de6c-f35a-49e8-9540-749197aebdba.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
Renal Health FormulaSARSAPARILLA (SMILAX REGELII), BERBERIS VULGARIS, LEONURUS CARDIACA, LYCOPODIUM CLAVATUM, NITRICUM ACIDUM, DIGITALIS PURPUREA, OXALICUM ACIDUM, URICUM ACIDUMNutritional Specialties, Inc.bc92de6c-f35a-49e8-9540-749197aebdba2023-08-23WarningsExact identifier
ndc (product): 83027-0102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0102-18302701020160 mL in 1 BOTTLE, SPRAY (83027-0102-1) 60 ml2023-08-23NoNoCurrent