Pleo Nig

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2009-10-08
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:58

Label at a glance#

ProductPleo Nig

Active ingredientaspergillus niger var. niger

Label structure8 sections

Dosage and administration

Snap off top portion of sipping container. Insert glass sipping straw.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Oral Homeopathic Medicine

50 doses, each 1 mL
(.03 fl oz)

INDICATIONS

INDICATIONS & USAGE SECTION

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

DIRECTIONS FOR USE

DOSAGE & ADMINISTRATION SECTION

Snap off top portion of sipping container. Insert glass sipping straw.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

1 SIP, twice weekly.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

1 mL contains Aspergillus niger 7X, in a base of purified saline solution.

WARNING

WARNINGS SECTION

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

SPL UNCLASSIFIED SECTION

Do not use this product if the glass vial is broken or if imprinted security strip on carton is torn.

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. 11/97

PRINCIPAL DISPLAY PANEL - 1 mL Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

2106-2

Pleo™ Nig
PORTABLE SIPS 7X

Oral Homeopathic Medicine

INDICATIONS: For temporary relief of ex-
ternal itching and soreness in the urogeni-
tal region.

DIRECTIONS FOR USE: Snap off top
portion of sipping container. Insert glass
sipping straw.

DOSAGE: 1 SIP, twice weekly.

INGREDIENTS: 1 mL contains Aspergil-
lus niger 7X, in a base of purified saline
solution.

convenient, disposable
single dose containers

50 doses, each 1 mL
(.03 fl oz)

Rev. 11/97

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-2106-1	2019-10-21	C162847	48780-1	956f9ecf-d665-621f-e053-dbdaa90a74ad	Pleo™ Nig PORTABLE SIPS 7X
60681-2106-2	2019-10-21	C162847	48780-1	956f9ecf-d665-621f-e053-dbdaa90a74ad	Pleo™ Nig PORTABLE SIPS 7X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
60681-2106-1	Pleo Nig	1 mL in 1 VIAL, GLASS	SOLUTION/ DROPS	1	1
60681-2106-1	Pleo Nig	10 in 1 CARTON	SOLUTION/ DROPS	10	1
60681-2106-2	Pleo Nig	50 in 1 CARTON	SOLUTION/ DROPS	50	1
60681-2106-2	Pleo Nig	1 mL in 1 VIAL, GLASS	SOLUTION/ DROPS	1	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-2106	PLEO NIG (ASPERGILLUS NIGER VAR. NIGER) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 4 package rows	20110113_dc84f8d3-4302-454f-b1c1-58cc54b231b1.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
sodium chloride	INACTIVE INGREDIENT	451W47IQ8X	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

Pleo Nig
aspergillus niger var. niger
water
sodium chloride

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-2106	60681-2106-1, 60681-2106-2

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
Name	UNII	Kind
aspergillus niger var. niger	9IOA40ANG6	ACTIB
water	059QF0KO0R	IACT
sodium chloride	451W47IQ8X	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 3 · 134 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / OPHTHALMIC		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / TOPICAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVESICAL		351 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRAVENOUS		2916 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / EPIDURAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERIDURAL	8.07 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / RESPIRATORY (INHALATION)		43 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOAP / TOPICAL	1.26 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACARDIAC		70 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INFILTRATION		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / ORAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	DROPS / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRATUMOR	1.2 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRALESIONAL	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION/ DROPS / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION/ DROPS / AURICULAR (OTIC)		3 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	0.68 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRA-ARTERIAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRAVASCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / PARENTERAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUPPOSITORY / RECTAL		140 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / AURICULAR (OTIC)	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INHALANT / RESPIRATORY (INHALATION)	3 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAPERITONEAL	226 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER / TOPICAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, ORALLY DISINTEGRATING / ORAL		10 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR		45 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SYSTEM / IONTOPHORESIS	3.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / NASAL	330 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	IMPLANT / SUBCUTANEOUS	77 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RECTAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	LIQUID / NASAL	7.4 mg/1ml		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	CAPSULE, EXTENDED RELEASE / ORAL		41 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / IONTOPHORESIS	0.6 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / SUBCUTANEOUS	0.8 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ENDOTRACHEAL	7.6 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	POWDER, FOR SUSPENSION / ENDOTRACHEAL	46.76 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, EMULSION / INTRAVENOUS	0.62 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBMUCOSAL		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	TABLET, COATED / ORAL	54.7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
sodium chloride	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / INTRA-ARTERIAL		278 mg	Exact identifier — unii candidate 134 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
c61152e0-1aad-4d81-9436-07ab4185a9cc			dc84f8d3-4302-454f-b1c1-58cc54b231b1	2009-10-08	Warnings	Exact identifier spl id: c61152e0-1aad-4d81-9436-07ab4185a9cc spl set id: dc84f8d3-4302-454f-b1c1-58cc54b231b1

Reported adverse events (FAERS/openFDA)#

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