FDA.reportPublic FDA data

NotaQuenSAN Nasal Spray

Manufacturer
sanPharmacy Inc. | Medsan Inc.
Effective date
2023-12-20
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:25:03

Label at a glance#

ProductNotaQuenSAN
Active ingredientPENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM GLABRUM
Label structure9 sections

Label contents#

Full prescribing information#

Indications

INDICATIONS & USAGE SECTION

For temporary relief of nasal congestion due to the common cold, upper respiratory allergies and hay fever.

OTC - PURPOSE SECTION

Nasal decongestant

Ingredients

OTC - ACTIVE INGREDIENT SECTION

Penicillium notatum (chrysogenum) 4X

Penicillium frequentans (glabrum) 4X

INACTIVE INGREDIENT SECTION

purified water

0.09g sodium chloride

0.01g potassium sorbate

Dosage

DOSAGE & ADMINISTRATION SECTION

Spray twice into each nostril 2-5 times daily.

Warning

WARNINGS SECTION

If symptoms persist more than 5 days, contact a licensed practitioner. If pregnant or breast-feeding, ask a health professional before use. Keep out of the reach of children. In case of ingestion call Poison Control Center hotline immediately at 1-800-222-1222. Protect from light and heat.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children.

STORAGE AND HANDLING SECTION

Protect from light and heat. Once opened do not use for more than 2 weeks.

Tamper Evident

SPL UNCLASSIFIED SECTION

Do not use product if tamper evident strip is broken. To report adverse events, contact MEDsan Inc. at 1-855-462-6334.

SPL UNCLASSIFIED SECTION

Manufactured in the USA for:
sanPharmacy Inc.
350 Fifth Avenue STE 5220

New York NY 10118-5220

Liability claim

SPL UNCLASSIFIED SECTION

These statements or claims are based upon traditional homeopathic practice. They have not been reviewed by the Food & Drug Administration.

RECENT MAJOR CHANGES SECTION

Boxed Warning

Indications and Usage

Warnings and Precautions

PRINCIPAL DISPLAY PANEL - 10 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NotaQuenSAN

Homeopathic
Medicine

For nasal
congestion

0.34 FL OZ
(10ml)

sanPharmacy
biological health solutions

NotaQuenSAN 10 mL Outer PackagingNotaQuenSAN 10 mL Outer PackagingNotaQuenSAN 10 mL LabelNotaQuenSAN 10 mL Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73479-029-062025-01-30C16284748780-1d6a99b39-5e92-a426-e053-dadaa90af4c2NotaQuenSAN Nasal Spray
73479-029-062023-09-19C16284748780-1d6a99b39-5e92-a426-e053-dadaa90af4c2NotaQuenSAN Nasal Spray
73479-029-062022-01-28C16284748780-1d6a99b39-5e92-a426-e053-dadaa90af4c2NotaQuenSAN Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73479-029-06NotaQuenSAN1 in 1 CARTONSPRAY13
73479-029-06NotaQuenSAN10 mL in 1 BOTTLE, SPRAYSPRAY103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73479-029NOTAQUENSAN (PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM GLABRUM) SPRAY [SANPHARMACY INC.]3Legacy NDC, 2 package rows20231221_990b24d4-96ba-1e7f-e053-2a95a90a75f6.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
73479-02973479-029-06

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
WATER059QF0KO0RIACT
SODIUM CHLORIDE451W47IQ8XIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM3Y1PE1GCIGACTIB
PENICILLIUM GLABRUM2IN23YUE0IACTIB

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
0cef86b0-d095-07bb-e063-6394a90a079d990b24d4-96ba-1e7f-e053-2a95a90a75f62023-12-20WarningsExact identifier
spl id: 0cef86b0-d095-07bb-e063-6394a90a079d
spl set id: 990b24d4-96ba-1e7f-e053-2a95a90a75f6

Reported adverse events (FAERS/openFDA)#

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