FDA.reportPublic FDA data

Passiflora incarnata

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-03-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:20:24

Label at a glance#

ProductPassiflora incarnata
Active ingredientPASSIFLORA INCARNATA FLOWERING TOP
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Passiflora incarnata 30X

(**contains 0.443 mg of the active ingredient per pellet)

INDICATIONS & USAGE SECTION

Occasional sleeplessness*

OTC - STOP USE SECTION

Stop use and ask a doctor 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

SPL UNCLASSIFIED SECTION

Do not use if pellet dispenser seal is broken.
Contains approx 80 pellets.
How to dispense pellets? Turn tube upside down. Twist until 5 pellets are dispensed into cap. Carefully remove the cap and use it to pour pellets under the tongue.
*CLAIMS BASED ON TRADITIONAL HOMEOPATHIC PRACTICE NOT ACCEPTED MEDICAL EVIDENCE. NOT FDA EVALUATED.
*C,K,CK, and X are homeopathic dilutions: see BoironUSA.com/info for details.

INACTIVE INGREDIENT SECTION

lactose, sucrose

DOSAGE & ADMINISTRATION SECTION

Adults and children: At the onset of symptoms, dissolve 5 pellets under the tongue 3 times a day until symptoms are relieved or as directed by a doctor.

OTC - QUESTIONS SECTION

1-800-BOIRON-1 (1-800-264-7661),
BoironUSA.com Info@boiron.com
Distributed by Boiron, Inc. Newtown Square, PA 19073

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0220-3933-412023-03-04C16284748780-1f386c649-e21c-0266-e053-dadaa90a7c1aPassiflora incarnata 30X
0220-3933-412023-01-30C16284748780-1f386c649-e21c-0266-e053-dadaa90a7c1aPassiflora incarnata 30X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-3933-41Passiflora incarnata30 [hp_X] in 1 TUBEPELLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-3933PASSIFLORA INCARNATA (PASSIFLORA INCARNATA FLOWERING TOP ) PELLET [BOIRON]2Current NDC, Legacy NDC, 1 package rows20230306_865c4aad-7d88-3938-e053-2a91aa0afab6.zip

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0220-39330220-3933-41

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT
SUCROSEC151H8M554IACT

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
Passiflora incarnataPASSIFLORA INCARNATA FLOWERING TOPBoiron865c4aad-7d88-3938-e053-2a91aa0afab62023-03-03Exact identifier
ndc (package): 0220-3933-41
ndc (product): 0220-3933
ndc11 (package): 00220393341
spl id: f600a30c-0576-2f36-e053-2a95a90a4da7
spl set id: 865c4aad-7d88-3938-e053-2a91aa0afab6

Reported adverse events (FAERS/openFDA)#

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