FDA.reportPublic FDA data

Urosode

Manufacturer
Natural Creations, Inc | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:13:17

Label at a glance#

ProductUrosode
Active ingredientARCTOSTAPHYLOS UVA-URSI LEAF, BOLETUS SATANAS FRUITING BODY, BERBERIS VULGARIS ROOT BARK, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CHLAMYDIA TRACHOMATIS, EQUISETUM HYEMALE WHOLE, LACHESIS MUTA VENOM, SUS SCROFA OVARY, SACCHAROMYCES CEREVISIAE, SOLIDAGO VIRGAUREA FLOWERING TOP, DELPHINIUM STAPHISAGRIA SEED
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amounts of: Uva Ursi 12C, Berber Vulg 30C, Boletus Sat 30C, Borrelia 30C, Candida Alb 30C, Cantharis 30C, Chlamydia 30C, Equisetum Hyem 30C, Lachesis 30C, Lymphogranuloma 30C, Oophorinum 30C, Saccharomyces Cerevisiae 30C, Solidago 30C, Staphysagria 30C.

INDICATIONS & USAGE SECTION

USES: Temporary relief of pain, burning, urinary frequency & urgency.**

OTC - PURPOSE SECTION

USES: Temporary relief of pain, burning, urinary frequency & urgency.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water.

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:43406-0090-1

Urosode

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0090-12022-01-28C16284748780-1d6a99b39-5fd3-a426-e053-dadaa90af4c2Urosode

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0090-1Urosode30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0090UROSODE (UVA URSI, BERBERIS VULGARIS, BOLETUS SATANAS, BORRELIA, CANDIDA ALBICANS, CANTHARIS, CHLAMYDIA, EQUISETUM HYEMALE, LACHESIS MUTUS, LYMPHOGRANULOMA, OOPHORINUM, SACCHAROMYCES CEREVISIAE, SOLIDAGO VIRGAUREA, STAPHYSAGRIA) LIQUID [NATURAL CREATIONS, INC]1Legacy NDC, 1 package rows20200821_504a58f6-1385-423a-af07-ef7d9491ce2a.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-009043406-0090-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ARCTOSTAPHYLOS UVA-URSI LEAF3M5V3D1X36ACTIB
BOLETUS SATANAS FRUITING BODY68OG1407SMACTIB
BERBERIS VULGARIS ROOT BARK1TH8Q20J0UACTIB
BORRELIA BURGDORFERI0J8NV9V5Q8ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
CHLAMYDIA TRACHOMATIST6NI39QU44ACTIB
EQUISETUM HYEMALE WHOLE59677RXH25ACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
SACCHAROMYCES CEREVISIAE978D8U419HACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
7e2e0ee3-8797-4934-a010-70da7a82ad80504a58f6-1385-423a-af07-ef7d9491ce2a2018-12-21WarningsExact identifier
spl id: 7e2e0ee3-8797-4934-a010-70da7a82ad80
spl set id: 504a58f6-1385-423a-af07-ef7d9491ce2a

Reported adverse events (FAERS/openFDA)#

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