FDA.reportPublic FDA data

CALCULI RENAL

Manufacturer
BM Private Limited
Effective date
2025-07-31
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:34:35

Label at a glance#

ProductCALCULI RENAL
Active ingredientTURPENTINE OIL, CHONDRODENDRON TOMENTOSUM ROOT, EPIGAEA REPENS, CORN SILK, COLEUS AMBOINICUS WHOLE, SARSAPARILLA, BERBERIS VULGARIS ROOT BARK
Label structure9 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Dosage:
Adult:10-15 drops
Children: half of the same
3 times a day in some water

OTC - ACTIVE INGREDIENT SECTION

berberis vulg, coleus arom, epigea rep, pareira brava, sarsaparilla, stigmata may, terenbitinae

INACTIVE INGREDIENT SECTION

ALCOHOL

INDICATIONS & USAGE SECTION

Help support to relieve the symptoms of kidney, ureter and bladder calculus,
for detail please read the enclosed package. (Product information leaflet).

OTC - PURPOSE SECTION

Help support to relieve the symptoms of kidney, ureter and bladder calculus,
for detail please read the enclosed package. (Product information leaflet).

CONTRAINDICATIONS SECTION

Care & contra-indications:
This is a homoeopathic remedy, no contra-indications are established.

WARNINGS SECTION

Precautions/storage:
Keep away from children and store at cool and dry place.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Precautions/storage:
Keep away from children and store at cool and dry place.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CALCULI RENALCALCULI RENAL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85816-6011-1CALCULI RENAL30 mL in 1 BOTTLE, GLASSLIQUID301

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85816-601185816-6011-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
TURPENTINE OILC5H0QJ6V7FACTIB
CHONDRODENDRON TOMENTOSUM ROOT395A3P448ZACTIB
EPIGAEA REPENS25CKM33EOXACTIB
CORN SILK7D3VB244UXACTIB
COLEUS AMBOINICUS WHOLET444G60821ACTIB
SARSAPARILLA2H1576D5WGACTIB
ALCOHOL3K9958V90MIACT
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB

Source Document#

Source XML

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
CALCULI RENALBERBERIS VULG, COLEUS AROM, EPIGEA REP, PAREIRA BRAVA, SARSAPARILLA, STIGMATA MAY, TERENBITINAEBM Private Limited3b3b3868-b816-84c0-e063-6394a90a457c2025-07-31WarningsExact identifier
ndc (package): 85816-6011-1
ndc (product): 85816-6011
ndc11 (package): 85816601101
spl id: 3b3b3868-b817-84c0-e063-6394a90a457c
spl set id: 3b3b3868-b816-84c0-e063-6394a90a457c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.