FDA.reportPublic FDA data

URTICA URENS

Manufacturer
SEVENE USA
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:32:04

Label at a glance#

ProductURTICA URENS 200CK
Active ingredientURTICA URENS
Label structure13 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS URTICA URENS 200CK

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Skin complaints such as itchy rash, burns, insects bites*

DOSAGE & ADMINISTRATION SECTION

Directions: (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

Dissolve 5 pellets under the tongue once a day until symptoms are relieved or as directed by a doctor.

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 SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

RECENT MAJOR CHANGES SECTION

Directions changed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

URTICA URENS 200CKURTICA URENS 200CK

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76472-4082-12025-02-11C16284748780-12cef2736-5cdc-d83d-e063-dadaa90ab31fSevene USA (as PLD) - URTICA URENS 200CK (76472-4082)
76472-4082-12025-01-30C16284748780-12cef2736-5cdc-d83d-e063-dadaa90ab31fSevene USA (as PLD) - URTICA URENS 200CK (76472-4082)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-4082-1URTICA URENS200CK80 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-4082URTICA URENS 200CK (URTICA URENS) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20250213_edaf67c2-6575-331f-e053-2a95a90a1099.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76472-408276472-4082-1

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
URTICA URENSIHN2NQ5OF9ACTIB

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
URTICA URENS 200CKURTICA URENSSEVENE USAedaf67c2-6575-331f-e053-2a95a90a10992025-02-11WarningsExact identifier
ndc (package): 76472-4082-1
ndc (product): 76472-4082
ndc11 (package): 76472408201
spl id: 2ddc7f39-9bb7-0ef4-e063-6394a90a32cc
spl set id: edaf67c2-6575-331f-e053-2a95a90a1099

Reported adverse events (FAERS/openFDA)#

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