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
LYCOSA TARANTULA15 [hp_X]/mL
THERIDION CURASSAVICUM15 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL
VESPA CRABRO15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
HAMAMELIS VIRGINIANA ROOT BARK/STEM BARK6 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]/mL
RANCID BEEF30 [hp_X]/mL
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
DIEFFENBACHIA SEGUINE15 [hp_X]/mL
CALENDULA OFFICINALIS FLOWERING TOP15 [hp_X]/mL
FORMICA RUFA15 [hp_X]/mL
GRINDELIA HIRSUTULA FLOWERING TOP15 [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
DAPHNE MEZEREUM BARK15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
PULEX IRRITANS15 [hp_X]/mL
TOXICODENDRON PUBESCENS LEAF15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 26 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
86M454L2TTInternal UNII lookup
9Z8D3HEM8LInternal UNII lookup
1NT28V9397Internal UNII lookup
K3ALM8S49HInternal UNII lookup
4N9P6CC1DXInternal UNII lookup
T7S323PKJSInternal UNII lookup
5405K23S50Internal UNII lookup
29SUH5R3HUInternal UNII lookup
7S82P3R43ZInternal UNII lookup
6T6CO7R3Z5Internal UNII lookup
O80TY208ZWInternal UNII lookup
S7V92P67HOInternal UNII lookup
G580B439YIInternal UNII lookup
T7J046YI2BInternal UNII lookup
01800C6E6BInternal UNII lookup
18E7415PXQInternal UNII lookup
55H0W83JO5Internal UNII lookup
IDB0NAZ6AIInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
VSW71SS07IInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
14453db1-05f6-db38-e063-6294a90ae301Available on FDA.report

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

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
Bug Bites - Itch StopperPYROGENIUM, 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, SOLIDAGONewton Laboratories, Inc.14453db1-05f6-db38-e063-6294a90ae3012024-03-22WarningsExact identifier
ndc (product): 55714-2583

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 ml2024-03-22NoNoCurrent