Pleo™ Nig TABLETS 5X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-10-12
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:51

Label at a glance#

ProductPleo Nig

Active ingredientaspergillus niger var. niger

Label structure9 sections

Storage and handling

Protect from light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Antipruritic Medicine

20 TABLETS

Indications

INDICATIONS & USAGE SECTION

For temporary relief of external itching and soreness in the urogenital region.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

1 tablet contains 250 mg Aspergillus niger 5X in a base of lactose, potato starch, magnesium stearate.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

1–3 tablets daily, either two hours before breakfast or at bedtime.

WARNING

WARNINGS SECTION

If symptoms persist more than a few days, contact your licensed practitioner. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health care professional before taking this product.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

STORAGE AND HANDLING SECTION

Protect from light and heat.

Tamper Evident

OTC - DO NOT USE SECTION

Do not use this product if imprinted inner blister pack is broken or if imprinted security strip on carton is torn.

Lot #:

SPL UNCLASSIFIED SECTION

Made in Germany.

Distributed by:
SANUM USA Corp.
1465 Slater Road
Ferndale, WA 98248

Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG

Rev. 03/2008

PRINCIPAL DISPLAY PANEL - 20 Tablets Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo™ Nig
TABLETS 5X

Homeopathic
Antipruritic Medicine

lndications: For temporary relief of
external itching and soreness in the
urogenital region.

ORIGINAL ENDERLEIN

20 TABLETS

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-2102-1	2019-10-21	C162847	48780-1	956f9ecf-d5c9-621f-e053-dbdaa90a74ad	Pleo™ Nig TABLETS 5X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-2102-1	Pleo Nig	20 in 1 BLISTER PACK	TABLET	20		1
60681-2102-1	Pleo Nig	1 in 1 CARTON	TABLET	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-2102	PLEO NIG (ASPERGILLUS NIGER VAR. NIGER) TABLET [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20110113_7efc76cd-31bb-42dc-9739-ed184b09e626.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
aspergillus niger var. niger	ACTIVE INGREDIENT	9IOA40ANG6	1
aspergillus niger var. niger	ACTIVE MOIETY	9IOA40ANG6	1
lactose	INACTIVE INGREDIENT	J2B2A4N98G	1
Magnesium Stearate	INACTIVE INGREDIENT	70097M6I30	1
Starch, Potato	INACTIVE INGREDIENT	8I089SAH3T	1

Products#

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

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

Pleo Nig
aspergillus niger var. niger
lactose
Starch, Potato
Magnesium Stearate

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-2102	60681-2102-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
aspergillus niger var. niger	9IOA40ANG6	ACTIB
lactose	J2B2A4N98G	IACT
Starch, Potato	8I089SAH3T	IACT
Magnesium Stearate	70097M6I30	IACT

Source Document#

Source XML

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 2 · 78 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET / BUCCAL	17.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / TOPICAL		104 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FOR SUSPENSION / ORAL		131 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CREAM / TOPICAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		9 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CONCENTRATE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / TRANSMUCOSAL		100 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / SUBCUTANEOUS	0.5 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	GRANULE, FOR SUSPENSION / ORAL		14 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, EXTENDED RELEASE / ORAL		173 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, DELAYED RELEASE / ORAL	231.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	IMPLANT / INTRAVITREAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Potato	STARCH, POTATO	8I089SAH3T	TABLET, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 3 equally ranked IID candidates
Starch, Potato	STARCH, POTATO	8I089SAH3T	TABLET / ORAL		458 mg	Exact identifier — unii candidate 3 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		620 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SOLUTION / RECTAL	8 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, CHEWABLE / ORAL		127 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE / ORAL	530 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING / ORAL		187 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, COATED / ORAL		184 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, SOLUTION / INTRAVENOUS	0.45 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	POWDER, FOR SOLUTION / ORAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / ORAL		25 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Starch, Potato	STARCH, POTATO	8I089SAH3T	TABLET, COATED / ORAL	1.37 mg		Exact identifier — unii candidate 3 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	LOZENGE / ORAL		420 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY	193.8 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / RECTAL	20 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	RING / VAGINAL		2 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	POWDER / VAGINAL	430 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, COATED PELLETS / ORAL	135.2 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER, FOR SUSPENSION / ORAL		120 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, EXTENDED RELEASE / ORAL		117 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION / INTRAMUSCULAR	203.5 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		47 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE / ORAL	256.4 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	133 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / ORAL	2500 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		53 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	FILM, EXTENDED RELEASE / TRANSDERMAL	675 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	INHALANT / ORAL	0.08 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	POWDER / RESPIRATORY (INHALATION)	0.13 mg		Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	INSERT / VAGINAL		69 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, EXTENDED RELEASE / ORAL	400 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE, EXTENDED RELEASE / ORAL	120 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, DELAYED RELEASE / ORAL		144 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	SUSPENSION / ORAL		64 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, FILM COATED / ORAL		96 mg	Exact identifier — unii candidate 39 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	TABLET, SUGAR COATED / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	SOLUTION / ORAL	1682 mg/15ml		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET / SUBLINGUAL		352 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	CAPSULE, COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 39 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	CAPSULE / RESPIRATORY (INHALATION)	44.4 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
lactose	LACTOSE	J2B2A4N98G	TABLET, CHEWABLE / ORAL		1412 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
Magnesium Stearate	MAGNESIUM STEARATE	70097M6I30	DROPS / ORAL	NA		Exact identifier — unii candidate 39 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
e5c16ad8-763d-4887-b2fd-e6e97f53fd23			7efc76cd-31bb-42dc-9739-ed184b09e626	2009-10-12	Warnings	Exact identifier spl id: e5c16ad8-763d-4887-b2fd-e6e97f53fd23 spl set id: 7efc76cd-31bb-42dc-9739-ed184b09e626

Reported adverse events (FAERS/openFDA)#

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