FDA.reportPublic FDA data

Lycopodium clavatum

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:59

Label at a glance#

ProductLycopodium clavatum
Active ingredientLYCOPODIUM CLAVATUM SPORE
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Indigestion; Cramping; Vomiting; Acidity; Migraine; Constipation, Desires sweets; Loss of self-confidence; Dry skin.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Lycopodium clavatum 15x, 10x, 200c, 30c.

OTC - PURPOSE SECTION

Indigestion; cramping; vomiting; Acidity; Migraine; Constipation, Desires sweets; Loss of self-confidence; Dry skin.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified water; USP Gluten-free, non-GMO, organic cane alcohol 20%.

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net - Questions? 1.800.448.7256

Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS:Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor. If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-6328-12022-01-28C16284748780-1d6a99b39-9a3b-a426-e053-dadaa90af4c2Lycopodium 6328L

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-6328-1Lycopodium clavatum30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-6328LYCOPODIUM CLAVATUM LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 1 package rows20201217_298a5510-527e-dafa-ccd0-cfb3c5c68e52.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
55714-632855714-6328-1

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
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB

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
b69a61a8-6302-4c11-e053-2a95a90a4376298a5510-527e-dafa-ccd0-cfb3c5c68e522020-12-16WarningsExact identifier
spl id: b69a61a8-6302-4c11-e053-2a95a90a4376
spl set id: 298a5510-527e-dafa-ccd0-cfb3c5c68e52

Reported adverse events (FAERS/openFDA)#

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