FDA.reportPublic FDA data

Renal Sarcode

Product NDC
83027-0100
11-digit product format
830270100
Labeler code
83027
Product ID
83027-0100_8e2f0d3a-f70e-4b37-9cb9-4008b92d880d
Type
HUMAN OTC DRUG
Nonproprietary name
Rubia Tinctorum, Urtica Dioica, Sarsaparilla (smilax Regelii), Berberis Vulgaris, Coccus Cacti, Benzoicum Acidum, Kidney (Bovine), Lithium Carbonicum, Lycopodium Clavatum, Petroselinum Sativum, Taraxacum Officinale, Colocynthis, Atropinum Sulphuricum, Calcarea Carbonica, Hydrangea Arborescens
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-08-11
Substance
RUBIA TINCTORUM ROOT; URTICA DIOICA WHOLE; SMILAX ORNATA ROOT; BERBERIS VULGARIS ROOT BARK; PROTORTONIA CACTI; BENZOIC ACID; BEEF KIDNEY; LITHIUM CARBONATE; LYCOPODIUM CLAVATUM SPORE; PETROSELINUM CRISPUM WHOLE; TARAXACUM OFFICINALE; CITRULLUS COLOCYNTHIS FRUIT PULP; ATROPINE SULFATE; OYSTER SHELL CALCIUM CARBONATE, CRUDE; HYDRANGEA ARBORESCENS ROOT
Active strength
3; 3; 4; 5; 5; 6; 6; 6; 6; 6; 6; 7; 10; 12; 12 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Ammonium Ion Binding Activity [MoA], Anticholinergic [EPC], Cholinergic Antagonists [MoA], Cholinergic Muscarinic Antagonist [EPC], Cholinergic Muscarinic Antagonists [MoA], Mood Stabilizer [EPC], Nitrogen Binding Agent [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Renal Sarcode
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
RUBIA TINCTORUM ROOT3 [hp_X]/mL
URTICA DIOICA WHOLE3 [hp_X]/mL
SMILAX ORNATA ROOT4 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK5 [hp_X]/mL
PROTORTONIA CACTI5 [hp_X]/mL
BENZOIC ACID6 [hp_X]/mL
BEEF KIDNEY6 [hp_X]/mL
LITHIUM CARBONATE6 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE6 [hp_X]/mL
PETROSELINUM CRISPUM WHOLE6 [hp_X]/mL
TARAXACUM OFFICINALE6 [hp_X]/mL
CITRULLUS COLOCYNTHIS FRUIT PULP7 [hp_X]/mL
ATROPINE SULFATE10 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE12 [hp_X]/mL
HYDRANGEA ARBORESCENS ROOT12 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0SVP95L23GInternal UNII lookup
710FLW4U46Internal UNII lookup
2H1576D5WGInternal UNII lookup
1TH8Q20J0UInternal UNII lookup
LZB7TFX1LTInternal UNII lookup
8SKN0B0MIMInternal UNII lookup
5HOC10FSICInternal UNII lookup
2BMD2GNA4VInternal UNII lookup
C88X29Y479Internal UNII lookup
1WZA4Y92EXInternal UNII lookup
39981FM375Internal UNII lookup
23H32AOH17Internal UNII lookup
03J5ZE7KA5Internal UNII lookup
2E32821G6IInternal UNII lookup
SFK828Q2DEInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
bb3e5fd7-11be-4f02-95b9-43a05c3b737fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6c78bd43-efb4-4aeb-b7d8-eff1532f7822Product name420250801
41231c1e-8789-4da7-ac52-77fa90a85bf5Product name220250304
e77ab9a2-80cf-4832-bff0-469bbc7cbcd0Product name220250214
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
5f84b7a7-523a-f042-dffb-1dadcd9b2407Product name420240110
0cbc6fb2-78c0-4b88-98f0-a4cc76ff95caProduct name120230719
04cd5dc0-102f-46cb-8dbc-ca38dd2628d0Product name320230317
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dfd25202-b8d2-4628-9213-f3e0f9eafce5Product name420210513
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205
4199bf9b-4718-828a-6dd6-ac2fbbd61687Product name120140508
4edd8af5-cea7-ae42-8023-e91c5335db1dProduct name120140508
d3908afb-7784-440f-c406-88294732d36aProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0100-1Renal Sarcode60 mL in 1 BOTTLE, SPRAYSPRAY601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0100RENAL SARCODE (RUBIA TINCTORUM, URTICA DIOICA, SARSAPARILLA (SMILAX REGELII), BERBERIS VULGARIS, COCCUS CACTI, BENZOICUM ACIDUM, KIDNEY (BOVINE), LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, COLOCYNTHIS, ATROPINUM SULPHURICUM, CALCAREA CARBONICA, HYDRANGEA ARBORESCENS) SPRAY [NUTRITIONAL SPECIALTIES, INC.]1Current NDC, 1 package rows20230812_bb3e5fd7-11be-4f02-95b9-43a05c3b737f.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 SarcodeRUBIA TINCTORUM, URTICA DIOICA, SARSAPARILLA (SMILAX REGELII), BERBERIS VULGARIS, COCCUS CACTI, BENZOICUM ACIDUM, KIDNEY (BOVINE), LITHIUM CARBONICUM, LYCOPODIUM CLAVATUM, PETROSELINUM SATIVUM, TARAXACUM OFFICINALE, COLOCYNTHIS, ATROPINUM SULPHURICUM, CALCAREA CARBONICA, HYDRANGEA ARBORESCENSNutritional Specialties, Inc.bb3e5fd7-11be-4f02-95b9-43a05c3b737f2023-08-11WarningsExact identifier
ndc (product): 83027-0100

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83027-0100-18302701000160 mL in 1 BOTTLE, SPRAY (83027-0100-1) 60 ml2023-08-11NoNoCurrent