FDA.reportPublic FDA data

RUTA GRAVEOLENS

Manufacturer
SEVENE USA
Effective date
2025-02-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:31:58

Label at a glance#

ProductRUTA GRAVEOLENS 200ck
Active ingredientRUTA GRAVEOLENS FLOWERING TOP
Label structure12 sections

Dosage and administration

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS RUTA GRAVEOLENS200ck **C,K, CK, AND X ARE HOMEOPATHIC DILUTIONS.

TRADITIONALLY USED FOR

OTC - PURPOSE SECTION

Stinging edemas from stings or allergies, relieved by cold*

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

(adults/children) Dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a physician.

USE

INDICATIONS & USAGE SECTION

Condition listed above or as directed by a physician.

WARNINGS

WARNINGS SECTION

Stop use and ask a physician if symptoms persist for more than 3 days or worsen.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

OTHER INFORMATION

OTHER SAFETY INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

Do not use if pellet-dispenser seal is broken.

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Sucrose.

QUESTIONS?

OTC - QUESTIONS SECTION

INFO@OLLOIS.COM * www.ollois.com * MADE IN FRANCE. NOT REVIEWED BY THE FDA AND NOT GUARANTEED TO BE EFFECTIVE. THIS HOMEOPATHIC DILUTION MAY NOT BE SUSCEPTIBLE TO SCIENTIFIC MEASUREMENT.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Page 1Page 1Page 2Page 2Page 3Page 3

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76472-3032-12025-02-10C16284748780-12cef2736-8048-d83d-e063-dadaa90ab31fSevene USA (as PLD) - RUTA GRAVEOLENS 200ck (76472-3032)
76472-3032-12025-01-30C16284748780-12cef2736-8048-d83d-e063-dadaa90ab31fSevene USA (as PLD) - RUTA GRAVEOLENS 200ck (76472-3032)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-3032-1RUTA GRAVEOLENS200ck80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-3032RUTA GRAVEOLENS 200CK (RUTA GRAVEOLENS) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20250212_cf898a11-a78e-342d-e053-2995a90a5b05.zip

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-303276472-3032-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
SUCROSEC151H8M554IACT
RUTA GRAVEOLENS FLOWERING TOPN94C2U587SACTIB

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
RUTA GRAVEOLENS 200ckRUTA GRAVEOLENSSEVENE USAcf898a11-a78e-342d-e053-2995a90a5b052025-02-10WarningsExact identifier
ndc (package): 76472-3032-1
ndc (product): 76472-3032
ndc11 (package): 76472303201
spl id: 2dcc6b2e-b3d5-e17b-e063-6294a90a2fd2
spl set id: cf898a11-a78e-342d-e053-2995a90a5b05

Reported adverse events (FAERS/openFDA)#

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