Pleo ® Oryzae DROPS 6X

Manufacturer: Sanum Kehlbeck GmbH & Co. KG
Effective date: 2010-06-04
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-06-01 02:02:21

Label at a glance#

ProductPleo Oryzae

Active ingredientaspergillus flavus var. oryzae

Label structure9 sections

Storage and handling

Protect fom light and heat.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Homeopathic Antifungal Medicine

0.34 fl oz
(10 mL)

Indications

INDICATIONS & USAGE SECTION

For discomfort related to cold feet and hands.

INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

10 mL Aspergillus oryzae 6X in a base of purified water.

Tamper Evident

OTC - DO NOT USE SECTION

Do not use this product if tamper-evident seal on base of bottle cap is missing or broken.

DOSAGE

DOSAGE & ADMINISTRATION SECTION

5-10 drops, once daily.

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 other 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 fom light and heat.

SPL UNCLASSIFIED SECTION

Made in Germany

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

Manufactured by:
Sanum-Kehlbeck
GmbH & Co. KG
Hoya, Germany

Rev. 03/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pleo^® Oryzae DROPS 6X

Homeopathic Antifungal Medicine

Indications: For discomfort related to cold feet and hands.

0.34 fl oz (10 mL)

Dosage: 5-10 drops, once daily. Warning: 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. 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. Protect from
light and heat. TAMPER EVIDENT: Do not use this product if tamper-evident seal on
base of bottle cap is missing or broken. INGREDIENTS: 10 mL Aspergillus oryzae 6X
in a base of purified water.

Rev. 04/2010

PRINCIPAL DISPLAY PANEL - 10 mL Bottle Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
60681-0021-1	2019-10-21	C162847	48780-1	956f9ecf-d2c6-621f-e053-dbdaa90a74ad	Pleo ® Oryzae DROPS 6X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
60681-0021-1	Pleo Oryzae	1 in 1 CARTON	SOLUTION/ DROPS	1		1
60681-0021-1	Pleo Oryzae	10 mL in 1 BOTTLE, DROPPER	SOLUTION/ DROPS	10		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
60681-0021	PLEO ORYZAE (ASPERGILLUS FLAVUS VAR. ORYZAE) SOLUTION/ DROPS [SANUM KEHLBECK GMBH & CO. KG]	1	Legacy NDC, 2 package rows	20100707_4870f541-5926-4f8a-97da-a9e2fe0a5c1a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
aspergillus flavus var. oryzae	ACTIVE INGREDIENT	Q6Z8UK5R3G	1
aspergillus flavus var. oryzae	ACTIVE MOIETY	Q6Z8UK5R3G	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

Pleo Oryzae
aspergillus flavus var. oryzae
water

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
60681-0021	60681-0021-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
aspergillus flavus var. oryzae	Q6Z8UK5R3G	ACTIB
water	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
15f8962a-0abe-42cf-9766-15d8508ba34d			4870f541-5926-4f8a-97da-a9e2fe0a5c1a	2010-06-04	Warnings	Exact identifier spl id: 15f8962a-0abe-42cf-9766-15d8508ba34d spl set id: 4870f541-5926-4f8a-97da-a9e2fe0a5c1a

Reported adverse events (FAERS/openFDA)#

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