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LACHESIS MUTUS

Sevene USA (as PLD) - Lachesis Mutus 200ck (76472-3022)

Approved
Approval ID

cf85728d-07c8-5a23-e053-2995a90aa6cd

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 22, 2025

Manufacturers
FDA

SEVENE USA

DUNS: 969332936

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

LACHESIS MUTUS

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code76472-3022
Product Classification
G
Generic Name
LACHESIS MUTUS
Product Specifications
Route of AdministrationSUBLINGUAL
Effective DateMay 22, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
LACHESIS MUTA VENOMActive
Quantity: 200 [kp_C] in 1 1
Code: VSW71SS07I
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 2/9/2017

lachesis 200k p1lachesis 200k p2lachesis 200k p3

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 2/21/2018

USE

Condition listed above or as directed by a physician.

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 2/21/2018

QUESTIONS?

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 11/23/2011

Keep out of reach of children.

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 2/21/2018

INACTIVE INGREDIENT

Sucrose.

OTHER SAFETY INFORMATION

LOINC: 60561-8Updated: 2/21/2018

OTHER INFORMATION

Store at room temperature.

OTC - DO NOT USE SECTION

LOINC: 50570-1Updated: 11/23/2011

Do not use if pellet-dispenser seal is broken.

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 2/21/2018

ACTIVE INGREDIENT

HOMEOPATHIC DILUTION OF HPUS LACHESIS MUTUS 200ck**C,K, CK, AND X ARE HOMEOPATHIC DILUTIONS.

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 2/21/2018

TRADITIONALLY USED FOR

Stinging edemas from stings or allergies, relieved by cold*

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 2/21/2018

DIRECTIONS

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

WARNINGS SECTION

LOINC: 34071-1Updated: 2/21/2018

WARNINGS

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

LOINC: 53414-9Updated: 11/23/2011

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

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LACHESIS MUTUS - FDA Drug Approval Details