FDA.reportPublic FDA data

Insect Bites

Product NDC
50845-0281
11-digit product format
508450281
Labeler code
50845
Product ID
50845-0281_0e92e39f-2391-463b-981e-260d442306b8
Type
HUMAN OTC DRUG
Nonproprietary name
Anthracinum, Apis Mellifica, Arnica Montana, Calendula Officinalis, Camphora, Conium Maculatum, Echinacea (Angustifolia), Grindelia, Histaminum Hydrochloricum, Hypericum Perforatum, Lachesis Mutus, Latrodectus Mactans, Ledum Palustre, Pyrogenium, Tarentula Cubensis
Dosage form
SPRAY
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2024-08-23
Substance
APIS MELLIFERA; ARNICA MONTANA WHOLE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CALENDULA OFFICINALIS FLOWERING TOP; CAMPHOR (NATURAL); CITHARACANTHUS SPINICRUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA WHOLE; GRINDELIA HIRSUTULA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM WHOLE; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; RANCID BEEF; RHODODENDRON TOMENTOSUM LEAFY TWIG
Active strength
6; 200; 200; 3; 6; 12; 200; 3; 6; 12; 6; 200; 30; 30; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], 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
Insect Bites
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT6 [hp_X]/mL
APIS MELLIFERA200 [hp_C]/mL
ARNICA MONTANA WHOLE200 [hp_C]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
CAMPHOR (NATURAL)6 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP12 [hp_X]/mL
ECHINACEA ANGUSTIFOLIA WHOLE200 [hp_C]/mL
GRINDELIA HIRSUTULA FLOWERING TOP3 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE6 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE12 [hp_X]/mL
LACHESIS MUTA VENOM6 [hp_X]/mL
LATRODECTUS MACTANS200 [hp_C]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG30 [hp_C]/mL
RANCID BEEF30 [hp_C]/mL
CITHARACANTHUS SPINICRUS6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 15 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
41LZ22DD4NInternal UNII lookup
7S82P3R43ZInternal UNII lookup
O80TY208ZWInternal UNII lookup
18E7415PXQInternal UNII lookup
N20HL7Q941Internal UNII lookup
Q28R5GF371Internal UNII lookup
VB06AV5US8Internal UNII lookup
IDB0NAZ6AIInternal UNII lookup
3POA0Q644UInternal UNII lookup
XK4IUX8MNBInternal UNII lookup
VSW71SS07IInternal UNII lookup
XJJ7QA858RInternal UNII lookup
877L01IZ0PInternal UNII lookup
29SUH5R3HUInternal UNII lookup
3Y5X6RT823Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
e36fd898-00b4-4b62-8440-f1f1710bb6b4Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0281-1Insect Bites30 mL in 1 BOTTLE, SPRAYSPRAY301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0281INSECT BITES (ANTHRACINUM, APIS MELLIFICA, ARNICA MONTANA, CALENDULA OFFICINALIS, CAMPHORA, CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), GRINDELIA, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, LACHESIS MUTUS, LATRODECTUS MACTANS, LEDUM PALUSTRE, PYROGENIUM, TARENTULA CUBENSIS) SPRAY [LIDDELL LABORATORIES, INC.]1Current NDC, 1 package rows20240824_e36fd898-00b4-4b62-8440-f1f1710bb6b4.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
Insect BitesANTHRACINUM, APIS MELLIFICA, ARNICA MONTANA, CALENDULA OFFICINALIS, CAMPHORA, CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), GRINDELIA, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, LACHESIS MUTUS, LATRODECTUS MACTANS, LEDUM PALUSTRE, PYROGENIUM, TARENTULA CUBENSISLiddell Laboratories, Inc.e36fd898-00b4-4b62-8440-f1f1710bb6b42024-08-23WarningsExact identifier
ndc (product): 50845-0281

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
50845-0281-15084502810130 mL in 1 BOTTLE, SPRAY (50845-0281-1) 30 ml2024-08-23NoNoCurrent