FDA.reportPublic FDA data

SinolM™ Fast Headache Pain Relief All-Natural Nasal Spray

Manufacturer
Sinol USA, Inc.
Effective date
2026-03-25
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:38:10

Label at a glance#

ProductSinolM Fast Headache Pain Relief All-Natural Nasal
Active ingredientCAPSICUM
Label structure11 sections

Indications and uses

Temporarily relieves: headache & migraine pain sinus cluster tension premenstrual & menstrual headaches

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 headache pain

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves:

  • headache & migraine pain
  • sinus
  • cluster tension
  • premenstrual & menstrual headaches

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 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 HEADACHE PAIN

NEW
FORMULA

Sinol m™

All-Natural Nasal Spray

Fast Headache Relief

  • Fast Relief from Headache Pain:
    • Sinus
    • Migraine
    • Tension
    • Cluster
    • Menstrual
  • Doctor Recommended
  • Non-Habit Forming
  • Non-Addictive

Sinol-M™ is a Homeopathic Drug
NDC# 1501300316
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
15013-003-162025-01-30C16284748780-1f386c64a-3999-0266-e053-dadaa90a7c1aSinolM™ Fast Headache Pain Relief All-Natural Nasal Spray
15013-003-162023-02-10C16284748780-1f386c64a-3999-0266-e053-dadaa90a7c1aSinolM™ Fast Headache Pain Relief All-Natural Nasal Spray
15013-003-162023-01-30C16284748780-1f386c64a-3999-0266-e053-dadaa90a7c1aSinolM™ Fast Headache Pain Relief All-Natural Nasal Spray

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
15013-003-16SinolM Fast Headache Pain Relief All-Natural Nasal15 mL in 1 BOTTLE, SPRAYSPRAY153

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
15013-00315013-003-16

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
CAPSICUM00UK7646FGACTIB
WATER059QF0KO0RIACT
SILVER3M4G523W1GIACT
ALOEV5VD430YW9IACT
EUCALYPTOLRV6J6604TKIACT
ROSEMARYIJ67X351P9IACT
SEA SALT87GE52P74GIACT
ASCORBIC ACIDPQ6CK8PD0RIACT

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 Fast Headache Pain Relief All-Natural NasalCAPSICUMSinol USA, Inc.21db347e-3325-4295-bcd8-40a371a001882026-03-25WarningsExact identifier
ndc (package): 15013-003-16
ndc (product): 15013-003
ndc11 (package): 15013000316
spl id: 50799ee8-6ebd-4c7c-8bd9-ca2620005b04
spl set id: 21db347e-3325-4295-bcd8-40a371a00188

Reported adverse events (FAERS/openFDA)#

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