Bug Bites - Itch Stopper

Product NDC
55714-2583
11-digit product format
557142583
Labeler code
55714
Product ID
55714-2583_144510b9-90b0-b2ca-e063-6394a90a3d09
Type
HUMAN OTC DRUG
Nonproprietary name
Pyrogenium, Apis mel., Aranea diadema, Arnica, Arsenicum alb., Azadirachta indica, Bryonia, Caladium seguinum, Calendula, Formica, Grindelia, Hypericum, Lachesis, Latrodectus mactans, Ledum, Mezereum, Nux vom., Pulex irritans, Rhus toxicodendron, Tarentula cubensis, Tarentula hispana, Theridion, Thuja occ., Vespa crabro, Echinacea, Hamamelis, Solidago
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-03-22
Substance
APIS MELLIFERA; ARANEUS DIADEMATUS; ARNICA MONTANA; ARSENIC TRIOXIDE; AZADIRACHTA INDICA BARK; BRYONIA ALBA ROOT; CALENDULA OFFICINALIS FLOWERING TOP; DAPHNE MEZEREUM BARK; DIEFFENBACHIA SEGUINE; ECHINACEA, UNSPECIFIED; FORMICA RUFA; GRINDELIA HIRSUTULA FLOWERING TOP; HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK; HYPERICUM PERFORATUM; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; LEDUM PALUSTRE TWIG; LYCOSA TARANTULA; PULEX IRRITANS; RANCID BEEF; SOLIDAGO VIRGAUREA FLOWERING TOP; STRYCHNOS NUX-VOMICA SEED; THERIDION CURASSAVICUM; THUJA OCCIDENTALIS LEAFY TWIG; TOXICODENDRON PUBESCENS LEAF; VESPA CRABRO
Active strength
15; 15; 15; 15; 16; 15; 15; 15; 15; 6; 15; 15; 6; 15; 15; 15; 15; 15; 15; 30; 6; 15; 15; 15; 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; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS], Seed Storage Proteins [CS], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Bug Bites - Itch Stopper
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA15 [hp_X]/mL
ARANEUS DIADEMATUS15 [hp_X]/mL
ARNICA MONTANA15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
AZADIRACHTA INDICA BARK16 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
DIEFFENBACHIA SEGUINE15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
FORMICA RUFA15 [hp_X]/mL
GRINDELIA HIRSUTULA FLOWERING TOP15 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]/mL
HYPERICUM PERFORATUM15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LATRODECTUS MACTANS15 [hp_X]/mL
LEDUM PALUSTRE TWIG15 [hp_X]/mL
LYCOSA TARANTULA15 [hp_X]/mL
PULEX IRRITANS15 [hp_X]/mL
RANCID BEEF30 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
THERIDION CURASSAVICUM15 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL
VESPA CRABRO15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, 6T6CO7R3Z5, O80TY208ZW, S7V92P67HO, G580B439YI, T7J046YI2B, 18E7415PXQ, X2N6E405GV, 01800C6E6B, 4N9P6CC1DX, 55H0W83JO5, IDB0NAZ6AI, T7S323PKJS, XK4IUX8MNB, VSW71SS07I, XJJ7QA858R, 877L01IZ0P, 86M454L2TT, L63DD62R8R, 29SUH5R3HU

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2583-1Bug Bites - Itch Stopper30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2583BUG BITES - ITCH STOPPER (PYROGENIUM, APIS MEL., ARANEA DIADEMA, ARNICA, ARSENICUM ALB., AZADIRACHTA INDICA, BRYONIA, CALADIUM SEGUINUM, CALENDULA, FORMICA, GRINDELIA, HYPERICUM, LACHESIS, LATRODECTUS MACTANS, LEDUM, MEZEREUM, NUX VOM., PULEX IRRITANS, RHUS TOXICODENDRON, TARENTULA CUBENSIS, TARENTULA HISPANA, THERIDION, THUJA OCC., VESPA CRABRO, ECHINACEA, HAMAMELIS, SOLIDAGO) LIQUID [NEWTON LABORATORIES, INC.]1Current NDC, 1 package rows20240324_14453db1-05f6-db38-e063-6294a90ae301.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2583-15571425830130 mL in 1 BOTTLE, GLASS (55714-2583-1) 30 ml2024-03-22NoNoHistorical