FDA.reportPublic FDA data

Notatum-Quentans Nasal Spray 4X

Manufacturer
BioResource Inc. | RubiePharm Arzneimittel GmbH
Effective date
2016-01-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:07:29

Label at a glance#

ProductNotatum-Quentans Nasal 4X
Active ingredientPenicillium Chrysogenum Var. Chrysogenum, Penicillium Glabrum
Label structure6 sections

Label contents#

Full prescribing information#

OTC - PURPOSE SECTION

Indications

INDICATIONS & USAGE SECTION

For relief of minor cold symptoms and nasal congestion.

Dosage

DOSAGE & ADMINISTRATION SECTION

Spray twice into each nostril three times daily.

OTC - ACTIVE INGREDIENT SECTION

Ingredients

INACTIVE INGREDIENT SECTION

10 ml Penicillium notatum (chrysogenum) 4X and Penicillium frequentans 4X in a base of purified water, 0.09g sodium chloride, 0.01g potassium sorbate.

Warning

WARNINGS SECTION

If symptoms persist more than a few days, contact a licensed practitioner.

OTC - PREGNANCY OR BREAST FEEDING SECTION

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. Protect from light and heat.

Tamper Evident

OTC - DO NOT USE SECTION

Do not use product if tamper evident strip is broken.

To report adverse events, contact BioResource at 707/664-9023 or bioresource2@prodigy.net

SPL UNCLASSIFIED SECTION

Distributed By:
BioResource Inc.
Cotati CA 94931

PRINCIPAL DISPLAY PANEL - 10 ml Bottle Box

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SanPharma™
Notatum-Quentans
Nasal-Spray 4X

Homeopathic
Medicine

For nasal congestion

RX

0.34 FL OZ
(10ml)

SanPharma ™

PRINCIPAL DISPLAY PANEL - 10 ml Bottle Box
PRINCIPAL DISPLAY PANEL - 10 ml Bottle Box

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54256-046-052020-01-31C16284748780-19d75b9d0-5446-f424-e053-dadaa90a57ceNotatum-Quentans Nasal Spray 4X

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54256-046-05Notatum-Quentans Nasal 4X10 mL in 1 BOTTLE, SPRAYSPRAY101
54256-046-05Notatum-Quentans Nasal 4X1 in 1 BOXSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54256-046NOTATUM-QUENTANS NASAL 4X (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM AND PENICILLIUM GLABRUM) SPRAY [BIORESOURCE INC.]1Legacy NDC, 2 package rows20160127_70d6bafc-e1b0-479b-a314-2992a495501e.zip

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
54256-04654256-046-05

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
Penicillium Chrysogenum Var. Chrysogenum3Y1PE1GCIGACTIB
Penicillium Glabrum2IN23YUE0IACTIB
Water059QF0KO0RIACT
Sodium chloride451W47IQ8XIACT
Potassium sorbate1VPU26JZZ4IACT

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
6998060c-d0a7-49b7-917a-7456e6f2637c70d6bafc-e1b0-479b-a314-2992a495501e2016-01-26WarningsExact identifier
spl id: 6998060c-d0a7-49b7-917a-7456e6f2637c
spl set id: 70d6bafc-e1b0-479b-a314-2992a495501e

Reported adverse events (FAERS/openFDA)#

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