Insect Bites

Product NDC
50845-0277
11-digit product format
508450277
Labeler code
50845
Product ID
50845-0277_3c18b2de-8961-472f-9552-f92e6928d6a9
Type
HUMAN OTC DRUG
Nonproprietary name
Anthracinum, Apis Mellifica, Arnica Montana, Calendula Officinalis, Conium Maculatum, Echinacea (Angustifolia), Euphorbia Pilulifera, Grindelia, Histaminum Hydrochloricum, Hypericum Perforatum, Lachesis Mutus, Latrodectus Mactans, Ledum Palustre, Pyrogenium, Tarentula Cubensis
Dosage form
LIQUID
Route
ORAL
Labeler
Liddell Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2021-07-16
Marketing end
2027-05-11
Substance
APIS MELLIFERA; ARNICA MONTANA WHOLE; BACILLUS ANTHRACIS IMMUNOSERUM RABBIT; CALENDULA OFFICINALIS FLOWERING TOP; CITHARACANTHUS SPINICRUS; CONIUM MACULATUM FLOWERING TOP; ECHINACEA ANGUSTIFOLIA WHOLE; EUPHORBIA HIRTA FLOWERING TOP; GRINDELIA HIRSUTULA FLOWERING TOP; HISTAMINE DIHYDROCHLORIDE; HYPERICUM PERFORATUM WHOLE; LACHESIS MUTA VENOM; LATRODECTUS MACTANS; RANCID BEEF; RHODODENDRON TOMENTOSUM LEAFY TWIG
Active strength
3; 200; 200; 3; 10; 200; 3; 6; 6; 12; 6; 200; 30; 30; 6 [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/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
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 · 8 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage50845-0277-1557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-28excluded productproduct8af77b9d5b6f…d9bbb34c5368…
2024-05-28 21:12 UTC · source 2024-05-28excluded packagepackage50845-0277-18af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14excluded productproduct834df4deac94…adcc014656a3…
2024-05-15 03:39 UTC · source 2024-05-14excluded packagepackage50845-0277-1834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-08excluded productproduct1332a3947898…d4bfe170f9cd…
2024-03-11 06:39 UTC · source 2024-03-08excluded packagepackage50845-0277-11332a3947898…d4bfe170f9cd…

Additional Listing Data#

Finished product
Yes
Brand name base
Insect Bites

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT200 [hp_C]/mL
APIS MELLIFERA3 [hp_X]/mL
ARNICA MONTANA WHOLE200 [hp_C]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP200 [hp_C]/mL
ECHINACEA ANGUSTIFOLIA WHOLE3 [hp_X]/mL
EUPHORBIA HIRTA FLOWERING TOP6 [hp_X]/mL
GRINDELIA HIRSUTULA FLOWERING TOP6 [hp_X]/mL
HISTAMINE DIHYDROCHLORIDE12 [hp_X]/mL
HYPERICUM PERFORATUM WHOLE6 [hp_X]/mL
LACHESIS MUTA VENOM200 [hp_C]/mL
LATRODECTUS MACTANS30 [hp_C]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG6 [hp_X]/mL
RANCID BEEF30 [hp_C]/mL
CITHARACANTHUS SPINICRUS10 [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
Q28R5GF371Internal UNII lookup
VB06AV5US8Internal UNII lookup
6H89ZY31MRInternal 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
f7b30297-0710-4319-b4ee-df485832d64dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50845-0277-12024-08-26C16284748780-1f386c649-9d8d-0266-e053-dadaa90a7c1aDRUG FACTS:
50845-0277-12023-01-30C16284748780-1f386c649-9d8d-0266-e053-dadaa90a7c1aDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50845-0277-1Insect Bites30 mL in 1 BOTTLE, SPRAYLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50845-0277INSECT BITES (ANTHRACINUM, APIS MELLIFICA, ARNICA MONTANA, CALENDULA OFFICINALIS, CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), EUPHORBIA PILULIFERA, GRINDELIA, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, LACHESIS MUTUS, LATRODECTUS MACTANS, LEDUM PALUSTRE, PYROGENIUM, TARENTULA CUBENSIS) LIQUID [LIDDELL LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20240828_f7b30297-0710-4319-b4ee-df485832d64d.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, CONIUM MACULATUM, ECHINACEA (ANGUSTIFOLIA), EUPHORBIA PILULIFERA, GRINDELIA, HISTAMINUM HYDROCHLORICUM, HYPERICUM PERFORATUM, LACHESIS MUTUS, LATRODECTUS MACTANS, LEDUM PALUSTRE, PYROGENIUM, TARENTULA CUBENSISLiddell Laboratories, Inc.f7b30297-0710-4319-b4ee-df485832d64d2024-08-26WarningsExact identifier
ndc (product): 50845-0277

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50845-0277-15084502770130 mL in 1 BOTTLE, SPRAY (50845-0277-1) 30 ml2021-07-162027-05-11NoNoCurrent