FDA.reportPublic FDA data

DULCAMARA

Manufacturer
SEVENE USA
Effective date
2025-02-11
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:32:05

Label at a glance#

ProductDULCAMARA 200
Active ingredientSOLANUM DULCAMARA TOP
Label structure13 sections

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

HOMEOPATHIC DILUTION OF HPUS DULCAMARA 200CK.

TRADITIONALLY USED FOR:

OTC - PURPOSE SECTION

Stuffy nose or joint pain after exposure to cold damp weather*

DOSAGE & ADMINISTRATION SECTION

Directions: (adults/children) Dissolve 5 pellets under the tongue once 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 SUSEPTIBLE TO SCIENTIFIC MEASUREMENT.

RECENT MAJOR CHANGES SECTION

Directions changed.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DULCAMARA 200ckDULCAMARA 200ck

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76472-4080-12025-02-11C16284748780-12cef2736-8676-d83d-e063-dadaa90ab31fSevene USA (as PLD) - DULCAMARA 200CK (76472-4080)
76472-4080-12025-01-30C16284748780-12cef2736-8676-d83d-e063-dadaa90ab31fSevene USA (as PLD) - DULCAMARA 200CK (76472-4080)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76472-4080-1DULCAMARA20080 in 1 CYLINDERPELLET804

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76472-4080DULCAMARA 200 (DULCAMARA) PELLET [SEVENE USA]4Current NDC, Legacy NDC, 1 package rows20250213_ee132389-fe5a-d5c6-e053-2a95a90a4895.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
76472-408076472-4080-1

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
SOLANUM DULCAMARA TOPKPS1B1162NACTIB

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
DULCAMARA 200DULCAMARASEVENE USAee132389-fe5a-d5c6-e053-2a95a90a48952025-02-11WarningsExact identifier
ndc (package): 76472-4080-1
ndc (product): 76472-4080
ndc11 (package): 76472408001
spl id: 2ddc3953-05fb-3920-e063-6294a90adf9e
spl set id: ee132389-fe5a-d5c6-e053-2a95a90a4895

Reported adverse events (FAERS/openFDA)#

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