FDA.reportPublic FDA data

Pilocarpus

Manufacturer
Boiron | Boiron, Inc.
Effective date
2023-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:24:19

Label at a glance#

ProductPilocarpus
Active ingredientPILOCARPUS JABORANDII LEAF
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Pilocarpus 30C

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

INDICATIONS & USAGE SECTION

Hypersalivation*

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
0220-4064-412023-11-14C16284748780-1f386c649-baec-0266-e053-dadaa90a7c1aPilocarpus 30C
0220-4064-412023-01-30C16284748780-1f386c649-baec-0266-e053-dadaa90a7c1aPilocarpus 30C

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0220-4064-41Pilocarpus30 [hp_C] in 1 TUBEPELLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0220-4064PILOCARPUS (PILOCARPUS JABORANDII LEAF ) PELLET [BOIRON]2Current NDC, Legacy NDC, 1 package rows20231115_8697a03b-704e-3a49-e053-2a91aa0a7271.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
0220-40640220-4064-41

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
SUCROSEC151H8M554IACT
PILOCARPUS JABORANDII LEAF26ZE1BZ2USACTIB
LACTOSE, UNSPECIFIED FORMJ2B2A4N98GIACT

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
PilocarpusPILOCARPUS JABORANDII LEAFBoiron8697a03b-704e-3a49-e053-2a91aa0a72712023-11-14Exact identifier
ndc (package): 0220-4064-41
ndc (product): 0220-4064
ndc11 (package): 00220406441
spl id: 0a2156c6-f8c3-4d37-e063-6394a90ae8d4
spl set id: 8697a03b-704e-3a49-e053-2a91aa0a7271

Reported adverse events (FAERS/openFDA)#

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