FDA.reportPublic FDA data

Headache-Migraine

Product NDC
55714-4798
11-digit product format
557144798
Labeler code
55714
Product ID
55714-4798_b594757c-7858-f918-e053-2995a90a1277
Type
HUMAN OTC DRUG
Nonproprietary name
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..
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
APIS MELLIFERA; ARABICA COFFEE BEAN; ARSENIC TRIOXIDE; ATROPA BELLADONNA; BLACK COHOSH; BRYONIA ALBA ROOT; CENTAUREA BENEDICTA; CLAVICEPS PURPUREA SCLEROTIUM; CONVALLARIA MAJALIS; CROTALUS HORRIDUS HORRIDUS VENOM; DIGITALIS; GELSEMIUM SEMPERVIRENS ROOT; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; MERCURY; MICRURUS CORALLINUS VENOM; NAJA NAJA VENOM; NITROGLYCERIN; PHOSPHORUS; SANGUINARIA CANADENSIS ROOT; STRYCHNOS IGNATII SEED; STRYCHNOS NUX-VOMICA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VIPERA BERUS VENOM
Active strength
6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 30; 15; 15; 15; 15; 15; 15; 6; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Nitrate Vasodilator [EPC], Nitrates [CS], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC], Vasodilation [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-4798-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-4798-10efc9e666f02…f202fb6c5f17…

Additional Listing Data#

Finished product
Yes
Brand name base
Headache-Migraine
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MICRURUS CORALLINUS VENOM6 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ATROPA BELLADONNA15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CENTAUREA BENEDICTA15 [hp_X]/mL
BLACK COHOSH15 [hp_X]/mL
ARABICA COFFEE BEAN15 [hp_X]/mL
CONVALLARIA MAJALIS15 [hp_X]/mL
CROTALUS HORRIDUS HORRIDUS VENOM15 [hp_X]/mL
DIGITALIS15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
GELSEMIUM SEMPERVIRENS ROOT15 [hp_X]/mL
NITROGLYCERIN6 [hp_X]/mL
STRYCHNOS IGNATII SEED15 [hp_X]/mL
MERCURY15 [hp_X]/mL
NAJA NAJA VENOM30 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
SANGUINARIA CANADENSIS ROOT15 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM15 [hp_X]/mL
VIPERA BERUS VENOM15 [hp_X]/mL
APIS MELLIFERA6 [hp_X]/mL
HYPERICUM PERFORATUM15 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 25 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
V0S6H36980Internal UNII lookup
S7V92P67HOInternal UNII lookup
WQZ3G9PF0HInternal UNII lookup
T7J046YI2BInternal UNII lookup
6L5ZL09795Internal UNII lookup
K73E24S6X9Internal UNII lookup
3SW678MX72Internal UNII lookup
QHH4HVF5QEInternal UNII lookup
YHA2XLJ956Internal UNII lookup
F1T8QT9U8BInternal UNII lookup
VSW71SS07IInternal UNII lookup
639KR60Q1QInternal UNII lookup
G59M7S0WS3Internal UNII lookup
1NM3M2487KInternal UNII lookup
FXS1BY2PGLInternal UNII lookup
ZZ4AG7L7VMInternal UNII lookup
269XH13919Internal UNII lookup
27YLU75U4WInternal UNII lookup
6IO182RP7AInternal UNII lookup
N9288CD508Internal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
994a037b-7165-3a1e-e053-2a95a90ad7ffAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7480e90b-004b-ebe4-2243-4f2fefdd9e78Product name220260128
3f158398-73f2-4b90-47d1-5c60e8719a98Product name920250721
ca6149a6-ded3-9f17-6c41-3e88f2c0c9c0Product name220250117
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
00358076-c817-430b-b924-11d717dc307cProduct name120160718
669af5aa-14f3-3df7-f100-5f580ffd43c1Product name120140508
6ff3bab7-2dce-8bea-d7ce-54687f0c01fbProduct name120140508
8bb82a1c-d0d0-fc27-011f-172e545f0382Product name120140508
cb03406d-e223-80bb-67d8-be80f9b6a4f2Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4798-1Headache-Migraine30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4798HEADACHE-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.]2Current NDC, Legacy NDC, 1 package rows20201204_994a037b-7165-3a1e-e053-2a95a90ad7ff.zip

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
Headache-MigraineELAPS 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..Newton Laboratories, Inc.994a037b-7165-3a1e-e053-2a95a90ad7ff2020-12-03WarningsExact identifier
ndc (product): 55714-4798

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4798-15571447980130 mL in 1 BOTTLE, GLASS (55714-4798-1) 30 ml2019-09-020000-00-00NoNoCurrent