FDA.reportPublic FDA data

Headache

Manufacturer
Forces of Nature
Effective date
2022-10-24
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:18:19

Label at a glance#

ProductHeadache Pain Management
Active ingredientIris Versicolor Root, Lavandula Angustifolia Subsp. Angustifolia Flowering Top, Silicon Dioxide
Label structure9 sections

Dosage and administration

Shake well before use. Apply to temples and back of the neck as needed, roll gently into the skin. For children under 2 years of age, consult a doctor before use.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active Ingredients
Iris Versicolor* 30C - Remedy for Headaches
Lavandula Vera* 12X - Remedy for Headaches and Lack of Focus
Silicea* 30C - Relieves Inflammation and Pressure

* USDA Certified Organic

Also Contains

INACTIVE INGREDIENT SECTION

Sesame Oil*, Lavandin Oil*, Rosemary Oil*

Indications

INDICATIONS & USAGE SECTION

For the temporary relief of headaches.

Directions

DOSAGE & ADMINISTRATION SECTION

Shake well before use. Apply to temples and back of the neck as needed, roll gently into the skin. For children under 2 years of age, consult a doctor before use.

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 2 without physician direction.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep all medicines out of the reach of children. Stop use and consult a doctor if condition worsens, or consult a doctor if symptoms show no improvement after 7 days.

Tips For Use

SPL UNCLASSIFIED SECTION

Headache Pain Management works by calming the system, helping to reduce inflammation. It helps relax muscles in your head and neck that can cause or prolong headaches.

It can offer complete relief from headache pain in as little as 3-5 minutes.

Headache Pain Management should be applied whenever you experience symptoms or pain. Simply apply 1-3 drops to the back of your neck and temples using your fingertip, or a cotton swab.

It is OK to use more than this to treat more severe headaches, or quicker relief. It is safe to use other headache products at the same time as Headache Pain Management.

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

Homeopathic
NDC #51393-7577-4

FORCES OF NATURE®

CERTIFIED ORGANIC MEDICINE℠

Headache

ROLLERBALL APPLICATOR

Topical Headache Medicine

  • Fast Relief from Tension
    and Sinus Headaches
  • Naturally occurring Anti-Inflammatory
    and Analgesic effect
  • Safe Pain Relief Without Harmful
    Side Effects
  • Rare Essential Oils
    by Elite Growers
    from Across
    the Planet

Lavendula
Vera

USDA
ORGANIC

.14 OZ/4 ml Rollerball

PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton
PRINCIPAL DISPLAY PANEL - 4 ml Bottle Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
51393-7577-12026-01-29C16284748780-149896155-b9e4-586f-e063-e6dba90add90Headache Pain Management
51393-7577-22026-01-29C16284748780-149896155-b9e4-586f-e063-e6dba90add90Headache Pain Management
51393-7577-42026-01-29C16284748780-149896155-b9e4-586f-e063-e6dba90add90Headache Pain Management

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51393-7577-1Headache Pain Management11 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS115
51393-7577-2Headache Pain Management33 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS335
51393-7577-4Headache Pain Management4 mL in 1 BOTTLE, DISPENSINGSOLUTION/ DROPS45

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51393-7577HEADACHE PAIN MANAGEMENT (IRIS VERSICOLOR ROOT, LAVANDULA ANGUSTIFOLIA FLOWERING TOP, AND SILICON DIOXIDE) SOLUTION/ DROPS [FORCES OF NATURE]5Legacy NDC, 3 package rows20221027_23a413b2-16fd-40d2-b0a2-3ea833a94140.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC2
Lavandula Angustifolia Flowering TopACTIVE INGREDIENT9YT4B71U8P2
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU42
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC2
Lavandula Angustifolia Flowering TopACTIVE MOIETY9YT4B71U8P2
Silicon DioxideACTIVE MOIETYETJ7Z6XBU42
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 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51393-757751393-7577-4, 51393-7577-1, 51393-7577-2

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
Lavandula Angustifolia Subsp. Angustifolia Flowering Top9YT4B71U8PACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Lavandin Oil9RES347CKGIACT
Rosemary Oil8LGU7VM393IACT
Sesame OilQX10HYY4QVIACT

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Sesame OilSESAME OILQX10HYY4QVCAPSULE / ORAL2325 mgExact identifier — unii candidate
2 equally ranked IID candidates
Sesame OilSESAME OILQX10HYY4QVINJECTION / INTRAMUSCULAR70 %v/vExact 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
6234b777-4c9b-454b-ad55-062b783ca40723a413b2-16fd-40d2-b0a2-3ea833a941402022-10-24WarningsExact identifier
spl id: 6234b777-4c9b-454b-ad55-062b783ca407
spl set id: 23a413b2-16fd-40d2-b0a2-3ea833a94140

Reported adverse events (FAERS/openFDA)#

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