Headache - Migraine
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2011-06-01
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:05:25
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
HEADACHE - MIGRAINE Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
DOSAGE & ADMINISTRATION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional.
ACTIVE INGREDIENT SECTION
Elaps corallinus 30x, Arsenicum alb. 15x, Belladonna 15x, Bryonia 15x, Carduus benedictus 15x, Cimicifuga 15x, Coffea cruda 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Gelsemium 15x, Glonoinum 15x, Ignatia 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nux vom. 15x, Phosphorus 15x, Rhus toxicodendron 15x, Sanguinaria 15x, Secale 15x, Vipera berus 15x, Apis mel. 3x, Hypericum 3x, Thuja occ. 3x.
PURPOSE SECTION
Formulated for associated symptoms such as throbbing pain, pressure, congestion, dizziness, nausea and light sensitivity.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane dispensing alcohol 20%.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions? 1.800.448.7256
WARNINGS SECTION
Warning: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.
PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant or nursing or if symptoms worsen or persist for more than a few days.
KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 7480e90b-004b-ebe4-2243-4f2fefdd9e78 | Product name | 2 | 20260128 |
| 3f158398-73f2-4b90-47d1-5c60e8719a98 | Product name | 9 | 20250721 |
| ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0 | Product name | 2 | 20250117 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 7792dadb-52b6-46b6-8fdf-80b1171065b5 | Product name | 1 | 20180810 |
| 00358076-c817-430b-b924-11d717dc307c | Product name | 1 | 20160718 |
| 669af5aa-14f3-3df7-f100-5f580ffd43c1 | Product name | 1 | 20140508 |
| 6ff3bab7-2dce-8bea-d7ce-54687f0c01fb | Product name | 1 | 20140508 |
| 8bb82a1c-d0d0-fc27-011f-172e545f0382 | Product name | 1 | 20140508 |
| cb03406d-e223-80bb-67d8-be80f9b6a4f2 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4444-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-499f-f424-e053-dadaa90a57ce | Headache - Migraine |
| 55714-4444-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-499f-f424-e053-dadaa90a57ce | Headache - Migraine |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4444-1 | Headache - Migraine | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 3 | |
| 55714-4444-2 | Headache - Migraine | 59.14 mL in 1 BOTTLE, GLASS | LIQUID | 59.14 | 3 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4444 | HEADACHE - MIGRAINE (ELAPS CORALLINUS, ARSENICUM ALB., BELLADONNA, BRYONIA, CARDUUS BENEDICTUS, CIMICIFUGA, COFFEA CRUDA, CONVALLARIA, CROTALUS HORRIDUS, DIGITALIS, GELSEMIUM, GLONOINUM, IGNATIA, LACHESIS, MERC. VIV., NAJA, NUX VOM., PHOSPHORUS, RHUS TOXICODENDRON, SANGUINARIA, SECALE, VIPERA BERUS, APIS MEL., HYPERICUM, THUJA OCC.) LIQUID [NEWTON LABORATORIES, INC.] | 3 | Legacy NDC, 2 package rows | 20140206_06f7619f-7913-e6f3-72c0-ab3a6455606e.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Apis Mellifera | ACTIVE INGREDIENT | 7S82P3R43Z | 3 | |
| Arabica Coffee Bean | ACTIVE INGREDIENT | 3SW678MX72 | 3 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 3 | |
| Atropa Belladonna | ACTIVE INGREDIENT | WQZ3G9PF0H | 3 | |
| Black Cohosh | ACTIVE INGREDIENT | K73E24S6X9 | 3 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 3 | |
| Centaurea Benedicta | ACTIVE INGREDIENT | 6L5ZL09795 | 3 | |
| Claviceps Purpurea Sclerotium | ACTIVE INGREDIENT | 01G9XEA93N | 3 | |
| Convallaria Majalis | ACTIVE INGREDIENT | QHH4HVF5QE | 3 | |
| Crotalus Horridus Horridus Venom | ACTIVE INGREDIENT | YHA2XLJ956 | 3 | |
| Digitalis | ACTIVE INGREDIENT | F1T8QT9U8B | 3 | |
| Gelsemium Sempervirens Root | ACTIVE INGREDIENT | 639KR60Q1Q | 3 | |
| Hypericum Perforatum | ACTIVE INGREDIENT | XK4IUX8MNB | 3 | |
| Lachesis Muta Venom | ACTIVE INGREDIENT | VSW71SS07I | 3 | |
| Mercury | ACTIVE INGREDIENT | FXS1BY2PGL | 3 | |
| Micrurus Corallinus Venom | ACTIVE INGREDIENT | V0S6H36980 | 3 | |
| Naja Naja Venom | ACTIVE INGREDIENT | ZZ4AG7L7VM | 3 | |
| Nitroglycerin | ACTIVE INGREDIENT | G59M7S0WS3 | 3 | |
| Phosphorus | ACTIVE INGREDIENT | 27YLU75U4W | 3 | |
| Sanguinaria Canadensis Root | ACTIVE INGREDIENT | N9288CD508 | 3 | |
| Strychnos Ignatii Seed | ACTIVE INGREDIENT | 1NM3M2487K | 3 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 3 | |
| Thuja Occidentalis Leafy Twig | ACTIVE INGREDIENT | 1NT28V9397 | 3 | |
| Toxicodendron Pubescens Leaf | ACTIVE INGREDIENT | 6IO182RP7A | 3 | |
| Vipera Berus Venom | ACTIVE INGREDIENT | 0ORO6NCA4M | 3 | |
| Apis Mellifera | ACTIVE MOIETY | 7S82P3R43Z | 3 | |
| Arabica Coffee Bean | ACTIVE MOIETY | 3SW678MX72 | 3 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 3 | |
| Atropa Belladonna | ACTIVE MOIETY | WQZ3G9PF0H | 3 | |
| Black Cohosh | ACTIVE MOIETY | K73E24S6X9 | 3 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 3 | |
| Centaurea Benedicta | ACTIVE MOIETY | 6L5ZL09795 | 3 | |
| Claviceps Purpurea Sclerotium | ACTIVE MOIETY | 01G9XEA93N | 3 | |
| Convallaria Majalis | ACTIVE MOIETY | QHH4HVF5QE | 3 | |
| Crotalus Horridus Horridus Venom | ACTIVE MOIETY | YHA2XLJ956 | 3 | |
| Digitalis | ACTIVE MOIETY | F1T8QT9U8B | 3 | |
| Gelsemium Sempervirens Root | ACTIVE MOIETY | 639KR60Q1Q | 3 | |
| Hypericum Perforatum | ACTIVE MOIETY | XK4IUX8MNB | 3 | |
| Lachesis Muta Venom | ACTIVE MOIETY | VSW71SS07I | 3 | |
| Mercury | ACTIVE MOIETY | FXS1BY2PGL | 3 | |
| Micrurus Corallinus Venom | ACTIVE MOIETY | V0S6H36980 | 3 | |
| Naja Naja Venom | ACTIVE MOIETY | ZZ4AG7L7VM | 3 | |
| Nitroglycerin | ACTIVE MOIETY | G59M7S0WS3 | 3 | |
| Phosphorus | ACTIVE MOIETY | 27YLU75U4W | 3 | |
| Sanguinaria Canadensis Root | ACTIVE MOIETY | N9288CD508 | 3 | |
| Strychnos Ignatii Seed | ACTIVE MOIETY | 1NM3M2487K | 3 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 3 | |
| Thuja Occidentalis Leafy Twig | ACTIVE MOIETY | 1NT28V9397 | 3 | |
| Toxicodendron Pubescens Leaf | ACTIVE MOIETY | 6IO182RP7A | 3 | |
| Vipera Berus Venom | ACTIVE MOIETY | 0ORO6NCA4M | 3 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 3 |
Products#
Every source-derived product name is available through these pages.
- Headache - Migraine
- Elaps corallinus, Arsenicum alb., Belladonna, Bryonia, Carduus benedictus, Cimicifuga, Coffea cruda, Convallaria, Crotalus horridus, Digitalis, Gelsemium, Glonoinum, Ignatia, Lachesis, Merc. viv., Naja, Nux vom., Phosphorus, Rhus toxicodendron, Sanguinaria, Secale, Vipera berus, Apis mel., Hypericum, Thuja occ.
- Micrurus Corallinus Venom
- Arsenic Trioxide
- Arsenic Cation (3+)
- Atropa Belladonna
- Bryonia Alba Root
- Centaurea Benedicta
- Black Cohosh
- Arabica Coffee Bean
- Convallaria Majalis
- Crotalus Horridus Horridus Venom
- Digitalis
- Gelsemium Sempervirens Root
- Nitroglycerin
- Strychnos Ignatii Seed
- Lachesis Muta Venom
- Mercury
- Naja Naja Venom
- Strychnos Nux-vomica Seed
- Phosphorus
- Toxicodendron Pubescens Leaf
- Sanguinaria Canadensis Root
- Claviceps Purpurea Sclerotium
- Vipera Berus Venom
- Apis Mellifera
- Hypericum Perforatum
- Thuja Occidentalis Leafy Twig
- Alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4444 | 55714-4444-1, 55714-4444-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 70961b8f-f9ce-5d67-2fc3-c652ac085bac | 06f7619f-7913-e6f3-72c0-ab3a6455606e | 2011-06-01 | Warnings | 70961b8f-f9ce-5d67-2fc3-c652ac085bac 06f7619f-7913-e6f3-72c0-ab3a6455606e |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
