FDA.reportPublic FDA data

SinolM™ Cold and Flu All-Natural Nasal Spray

Manufacturer
Sinol USA, Inc.
Effective date
2025-01-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:31:38

Label at a glance#

ProductSinolM Cold and Flu All-Natural
Active ingredientCAPSICUM
Label structure11 sections

Indications and uses

Temporarily relieves: headache congestion fever sneezing and runny nose

Dosage and administration

Shake bottle before each use 1 spray in each nostril as needed up to 8 sprays per day Children under 12 consult with a health practitioner before use

Storage and handling

Store between 68 to 77 F (20 to 25 C) Retain carton for future reference

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts:

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Capsicum 4x HPUS (Capsaicin)

Purpose

OTC - PURPOSE SECTION

Relief of congestion, headache pain, fever, sneezing & runny nose

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:

  • headache
  • congestion
  • fever
  • sneezing and runny nose

Warnings

WARNINGS SECTION

OTC - DO NOT USE SECTION

  • do not use if you are allergic to any of the ingredients

OTC - WHEN USING SECTION

  • use of this container by more than 1 person may spread infection
  • do not spray in or around eyes
  • you may experience a mild burning sensation for 2-5 seconds

OTC - PREGNANCY OR BREAST FEEDING SECTION

  • If pregnant or breast feeding, ask a health professional before use

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

  • Keep out of reach of children

Other Information

STORAGE AND HANDLING SECTION

  • Store between 68 to 77 F (20 to 25 C)
  • Retain carton for future reference

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake bottle before each use
  • 1 spray in each nostril as needed up to 8 sprays per day
  • Children under 12 consult with a health practitioner before use

Other Information

SPL UNCLASSIFIED SECTION

Other Ingredients

INACTIVE INGREDIENT SECTION

Purified water, Patented Nano-Silver (natural preservative) Aloe Vera Extract, Eucalyptol, Rosemary Extract, Sea Salt and Vitamin C

Questions or comments

OTC - QUESTIONS SECTION

www.sinolusa.com or info@sinolusa.com

SPL UNCLASSIFIED SECTION

Distributed by:
Sinol USA, Inc.
PO Box 735
Newtown, CT 06470

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FAST RELIEF
FROM COLDS & FLU

NEW
FORMULA

Sinol m™

All-Natural Nasal Spray

Fast Cold & Flu Relief

Fast Relief from:

  • Headache
  • Congestion
  • Fever
  • Sneezing
  • Runny Nose

Sinol-M™ is a Homeopathic Drug
NDC# 1501300447
15 ml. (114 Sprays)

PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
15013-004-472023-02-10C16284748780-1f386c649-c915-0266-e053-dadaa90a7c1aSinolM™ Cold and Flu All-Natural Nasal Spray
15013-004-472023-01-30C16284748780-1f386c649-c915-0266-e053-dadaa90a7c1aSinolM™ Cold and Flu All-Natural Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15013-004-47SinolM Cold and Flu All-Natural15 mL in 1 BOTTLE, SPRAYSPRAY153

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
15013-004SINOLM COLD AND FLU ALL-NATURAL (CAPSICUM) SPRAY [SINOL USA, INC.]3Current NDC, Legacy NDC, 1 package rows20250130_2c2e8b02-3103-4b6e-b376-23da65a9b7fd.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
15013-00415013-004-47

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
SILVER3M4G523W1GIACT
ALOEV5VD430YW9IACT
EUCALYPTOLRV6J6604TKIACT
ROSEMARYIJ67X351P9IACT
SEA SALT87GE52P74GIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
CAPSICUM00UK7646FGACTIB

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
SinolM Cold and Flu All-NaturalCAPSICUMSinol USA, Inc.2c2e8b02-3103-4b6e-b376-23da65a9b7fd2025-01-29WarningsExact identifier
ndc (package): 15013-004-47
ndc (product): 15013-004
ndc11 (package): 15013000447
spl id: 2cdda0e3-c3b5-4b8b-e063-6294a90a45c5
spl set id: 2c2e8b02-3103-4b6e-b376-23da65a9b7fd

Reported adverse events (FAERS/openFDA)#

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