FDA.reportPublic FDA data

Migraine

Manufacturer
Forces of Nature
Effective date
2020-04-27
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 02:13:03

Label at a glance#

ProductMigraine Pain Management
Active ingredientIris Versicolor Root, Sodium Chloride
Label structure8 sections

Dosage and administration

Apply to temples and back of the neck as needed, gently rub into skin. For children under 2 years of age, consult a doctor first.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

CONTROL DRUG FACTS

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Iris Versicolor130C - Relieves chronic headaches and shooting pain

Natrum Muriaticum130C - Relieves pain due to migraines

Also Contains

INACTIVE INGREDIENT SECTION

Sesame Oil1, Lavandin Oil1, Roman Chamomile Oil1, Rosemary Oil1

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of migraine headaches.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply to temples and back of the neck as needed, gently rub into skin. For children under 2 years of age, consult a doctor first.

Warnings

WARNINGS SECTION

Some individuals may be sensitive to essential oils. Begin with a small drop to determine if the product causes any increased redness or irritation and discontinue use if it irritates your skin.

For external use only. If accidental ingestion of more than several drops, and adverse reaction occurs, get medical help or contact a Poison Control Center. Do not apply to the eyes. If you are pregnant or breast - feeding, ask a health professional before use. Not for use on children under the age of 3.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of the reach of children.

OTC - STOP USE SECTION

Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

SPL UNCLASSIFIED SECTION

Manufactured & Distributed by
FORCES OF NATURE®
21787 8th St East #3A Sonoma, CA 95476 USA

PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ORGANIC

NDC #51393-7588-4

FORCES OF NATURE®
CERTIFIED ORGANIC MEDICINESM

Migraine
ROLLERBALL APPLICATOR

Topical Migraine Medicine

  • Rapid Relief for
    Acute Migraine Pain
  • Deep Penetrating Action
  • All Natural Analgesic
  • Rare Essential Oils
    by Elite Growers
    from Across
    the Planet

Iris
Versicolor

.14 OZ/4 ml Rollerball

Principal Display Panel - 4 ml Bottle Carton
Principal Display Panel - 4 ml Bottle Carton

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
a21a21e5-f36d-4c1f-8918-def921b8f7e3Product name320250124
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51393-7588-12020-04-27C16284748780-19d75b9d0-f10c-f424-e053-dadaa90a57ceMigraine Pain Management
51393-7588-22020-04-27C16284748780-19d75b9d0-f10c-f424-e053-dadaa90a57ceMigraine Pain Management
51393-7588-42020-04-27C16284748780-19d75b9d0-f10c-f424-e053-dadaa90a57ceMigraine Pain Management
51393-7588-12020-01-31C16284748780-19d75b9d0-f10c-f424-e053-dadaa90a57ceMigraine Pain Management
51393-7588-22020-01-31C16284748780-19d75b9d0-f10c-f424-e053-dadaa90a57ceMigraine Pain Management
51393-7588-42020-01-31C16284748780-19d75b9d0-f10c-f424-e053-dadaa90a57ceMigraine Pain Management

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-7588-1Migraine Pain Management11 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS114
51393-7588-2Migraine Pain Management33 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS334
51393-7588-4Migraine Pain Management4 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS44

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-7588MIGRAINE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT AND SODIUM CHLORIDE) SOLUTION/ DROPS [FORCES OF NATURE]4Legacy NDC, 3 package rows20200428_2d3faa4f-c0a0-4989-8fa6-689d0382e123.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC2
Sodium ChlorideACTIVE INGREDIENT451W47IQ8X2
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC2
Sodium CationACTIVE MOIETYLYR4M0NH372
Chamaemelum Nobile Flower OilINACTIVE INGREDIENTUB275878392
Lavandin OilINACTIVE INGREDIENT9RES347CKG2
Rosemary OilINACTIVE INGREDIENT8LGU7VM3932
Sesame OilINACTIVE INGREDIENTQX10HYY4QV2

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
51393-758851393-7588-1, 51393-7588-2, 51393-7588-4

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
Iris Versicolor RootX43D4L3DQCACTIB
Sodium Chloride451W47IQ8XACTIB
Chamaemelum Nobile Flower OilUB27587839IACT
Lavandin Oil9RES347CKGIACT
Rosemary Oil8LGU7VM393IACT
Sesame OilQX10HYY4QVIACT

Source Document#

Source XML · Source PDF

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sesame OilSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact identifier — unii candidate
2 equally ranked IID candidates
Sesame OilSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
2 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
0e50403b-de8a-4788-af58-5b123cf7df962d3faa4f-c0a0-4989-8fa6-689d0382e1232020-04-27WarningsExact identifier
spl id: 0e50403b-de8a-4788-af58-5b123cf7df96
spl set id: 2d3faa4f-c0a0-4989-8fa6-689d0382e123

Reported adverse events (FAERS/openFDA)#

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