Headache-Migraine

Product NDC
55714-4863
11-digit product format
557144863
Labeler code
55714
Product ID
55714-4863_45002c8b-375a-2d00-e063-6294a90aad56
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
2025-12-02
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; 16 [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

Related Records

Related UNII Ingredients

UNIIPreferred termRegistry numberMatched term
7S82P3R43ZAPIS MELLIFERAAPIS MELLIFERA
3SW678MX72ARABICA COFFEE BEANARABICA COFFEE BEAN
S7V92P67HOARSENIC TRIOXIDE1327-53-3ARSENIC TRIOXIDE
WQZ3G9PF0HATROPA BELLADONNAATROPA BELLADONNA
K73E24S6X9BLACK COHOSHBLACK COHOSH
T7J046YI2BBRYONIA ALBA ROOTBRYONIA ALBA ROOT
6L5ZL09795CENTAUREA BENEDICTACENTAUREA BENEDICTA
01G9XEA93NCLAVICEPS PURPUREA SCLEROTIUMCLAVICEPS PURPUREA SCLEROTIUM
QHH4HVF5QECONVALLARIA MAJALISCONVALLARIA MAJALIS
YHA2XLJ956CROTALUS HORRIDUS HORRIDUS VENOMCROTALUS HORRIDUS HORRIDUS VENOM
F1T8QT9U8BDIGITALIS8031-42-3DIGITALIS
639KR60Q1QGELSEMIUM SEMPERVIRENS ROOTGELSEMIUM SEMPERVIRENS ROOT
XK4IUX8MNBHYPERICUM PERFORATUMHYPERICUM PERFORATUM
VSW71SS07ILACHESIS MUTA VENOMLACHESIS MUTA VENOM
FXS1BY2PGLMERCURY7439-97-6MERCURY
V0S6H36980MICRURUS CORALLINUS VENOMMICRURUS CORALLINUS VENOM
ZZ4AG7L7VMNAJA NAJA VENOMNAJA NAJA VENOM
G59M7S0WS3NITROGLYCERIN55-63-0NITROGLYCERIN
27YLU75U4WPHOSPHORUS7723-14-0PHOSPHORUS
N9288CD508SANGUINARIA CANADENSIS ROOTSANGUINARIA CANADENSIS ROOT
1NM3M2487KSTRYCHNOS IGNATII SEEDSTRYCHNOS IGNATII SEED
269XH13919STRYCHNOS NUX-VOMICA SEED8046-97-7STRYCHNOS NUX-VOMICA SEED
1NT28V9397THUJA OCCIDENTALIS LEAFY TWIGTHUJA OCCIDENTALIS LEAFY TWIG
6IO182RP7ATOXICODENDRON PUBESCENS LEAFTOXICODENDRON PUBESCENS LEAF
0ORO6NCA4MVIPERA BERUS VENOMVIPERA BERUS VENOM

Packages

Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-4863-15571448630130 mL in 1 BOTTLE, GLASS (55714-4863-1) 30 ml2025-12-02NoNoHistorical

Related DailyMed Labels

TitleManufacturerEffective dateTypeVersion
Headache 4863LNewton Laboratories, Inc.2025-12-02HUMAN OTC DRUG LABEL1