Sabal Serrulatum

Manufacturer
Marco Pharma International LLC. | Nestmann Pharma GmbH
Effective date
2026-01-12
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:36:42

Label at a glance#

ProductSabal Serrulatum
Active ingredientSAW PALMETTO, LYCOPODIUM CLAVATUM SPORE, CHONDRODENDRON TOMENTOSUM ROOT
Label structure2 sections

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Saw Palmetto 1xHPUS

Club Moss 4xHPUS

Pareira 4xHPUS

The letters HPUS indicates that the components in this product are officially monographed in the Homeopathic Pharmacopoeia of United Sates.

Purpose

OTC - PURPOSE SECTION

For relief of difficult urination; prostate afflictions.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

Suggested use

INDICATIONS & USAGE SECTION

In acute disorders, take 10 drops in pure water every hour until improvement is felt. Then take 25 drops in pure water three times daily after or between meals.

Warnings

WARNINGS SECTION

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

DOSAGE & ADMINISTRATION SECTION

(Read Suggested Use Section)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ethyl alcohol (65% by vol.) and water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

N15_60986-1009-3-4N15_60986-1009-3-4

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60986-1009-32020-12-04C16284748780-19d75b9d0-965b-f424-e053-dadaa90a57ceDrug Facts
60986-1009-42020-12-04C16284748780-19d75b9d0-965b-f424-e053-dadaa90a57ceDrug Facts
60986-1009-32020-01-31C16284748780-19d75b9d0-965b-f424-e053-dadaa90a57ceDrug Facts
60986-1009-42020-01-31C16284748780-19d75b9d0-965b-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60986-1009-3Sabal Serrulatum50 mL in 1 BOTTLE, GLASSLIQUID507
60986-1009-4Sabal Serrulatum100 mL in 1 BOTTLE, GLASSLIQUID1007

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CHONDRODENDRON TOMENTOSUM ROOTACTIVE INGREDIENT395A3P448Z2
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y4792
SAW PALMETTOACTIVE INGREDIENTJ7WWH9M8QS2
CHONDRODENDRON TOMENTOSUM ROOTACTIVE MOIETY395A3P448Z2
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y4792
SAW PALMETTOACTIVE MOIETYJ7WWH9M8QS2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
WATERINACTIVE INGREDIENT059QF0KO0R2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60986-100960986-1009-3, 60986-1009-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 3 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Sabal SerrulatumSABAL SERULATUM, LYCOPODIUM CLAVATUM, PAREIRA BRAVAMarco Pharma International LLC.158394db-fc09-4a17-a55b-12329d972c2a2026-01-12WarningsExact identifier
ndc (package): 60986-1009-3
ndc (package): 60986-1009-4
ndc (product): 60986-1009
ndc11 (package): 60986100904
ndc11 (package): 60986100903
spl id: 483c0b7f-aa46-c983-e063-6294a90a16c2
spl set id: 158394db-fc09-4a17-a55b-12329d972c2a

Reported adverse events (FAERS/openFDA)#

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