FDA.reportPublic FDA data

Stopain Migraine Topical Pain Relieving Gel

Manufacturer
TROY MANUFACTURING, INC
Effective date
2025-11-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:35:23

Label at a glance#

ProductStopain Migraine Pain Relieving
Active ingredientMENTHOL, UNSPECIFIED FORM, ATROPA BELLADONNA, IRIS VERSICOLOR ROOT, SANGUINARIA CANADENSIS ROOT
Label structure7 sections

Indications and uses

Provides temporary relief from migraine symptoms such as: Headaches Sensitivity to light nausea

Dosage and administration

Adults and children over 12 years: Remove cap. For the initial use, press down several times to prime the actuator pump. After priming, press and release the pump once to dispense gel onto your fingertips. Apply the gel to one side of the back of your neck and behind your ear, then repeat on the other side, using one pump for each application. For optimal results, apply as soon as you experience discomfort. If sym...

Storage and handling

Store at room temperature.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Mentholum 1X HPUS-50.00%

Belladonna 3X HPUS-1.33%

Iris Versicolor 6X HPUS-1.33%

Sanguinaria Canadensis 6X HPUS-1.33%

Purpose

OTC - PURPOSE SECTION

Migraine Pain

Uses

INDICATIONS & USAGE SECTION

Provides temporary relief from migraine symptoms such as:

  • Headaches
  • Sensitivity to light
  • nausea

Warnings

WARNINGS SECTION

For external use only. Avoid contact with eyes.

Flammable: Keep away from fire or flame

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • do not bandage tightly or use a heating pad
  • do not apply to the forehead or temples
  • do not apply to wounds or damaged skin

Stop and consult a doctor if

OTC - STOP USE SECTION

  • condition worsens, or symptoms persist for more than 7 days or clear up and occur again within a few days
  • redness or excessive irritation occurs

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a healthcare professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

Remove cap. For the initial use, press down several times to prime the actuator pump. After priming, press and release the pump once to dispense gel onto your fingertips. Apply the gel to one side of the back of your neck and behind your ear, then repeat on the other side, using one pump for each application. For optimal results, apply as soon as you experience discomfort. If symptoms persist after 30 minutes, you may reapply as needed, up to 4 times a day. Children under 12 years of age: do not use; consult a doctor.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbopol polymer, ethanol (USP), pentylene glycol, silicone dioxide, triethanolamine, water (USP)

Other Information

STORAGE AND HANDLING SECTION

Store at room temperature.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1LabelLabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63936-8700-1Stopain Migraine Pain Relieving1 in 1 CARTONGEL17
63936-8700-1Stopain Migraine Pain Relieving50 mL in 1 BOTTLE, PUMPGEL507
63936-8700-2Stopain Migraine Pain Relieving50 mL in 1 BOTTLE, PUMPGEL507

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H1
IRIS VERSICOLOR ROOTACTIVE INGREDIENTX43D4L3DQC1
MENTHOL, UNSPECIFIED FORMACTIVE INGREDIENTL7T10EIP3A1
SANGUINARIA CANADENSIS ROOTACTIVE INGREDIENTN9288CD5081
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H1
IRIS VERSICOLOR ROOTACTIVE MOIETYX43D4L3DQC1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SANGUINARIA CANADENSIS ROOTACTIVE MOIETYN9288CD5081
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
PENTYLENE GLYCOLINACTIVE INGREDIENT50C1307PZG1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63936-870063936-8700-1, 63936-8700-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PENTYLENE GLYCOL50C1307PZGIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
IRIS VERSICOLOR ROOTX43D4L3DQCACTIB
SANGUINARIA CANADENSIS ROOTN9288CD508ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 9 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GEL / TOPICAL6 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
3 equally ranked IID candidates

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
Stopain Migraine Pain RelievingMENTHOLUM, BELLADONNA, IRIS VERSICOLOR, SANGUINARIA CANADENSISTROY MANUFACTURING, INC5641c17f-bf3f-48a5-a3a8-c80d381c17a42025-11-24WarningsExact identifier
ndc (package): 63936-8700-1
ndc (package): 63936-8700-2
ndc (product): 63936-8700
ndc11 (package): 63936870001
ndc11 (package): 63936870002
spl id: 445b24c0-e964-e781-e063-6394a90a6f9d
spl set id: 5641c17f-bf3f-48a5-a3a8-c80d381c17a4

Reported adverse events (FAERS/openFDA)#

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