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

Additional Listing Data#

Finished product
Yes
Brand name base
Insect Bites

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APIS MELLIFERA3 [hp_X]/mL
ARNICA MONTANA WHOLE200 [hp_C]/mL
BACILLUS ANTHRACIS IMMUNOSERUM RABBIT200 [hp_C]/mL
CALENDULA OFFICINALIS FLOWERING TOP3 [hp_X]/mL
CITHARACANTHUS SPINICRUS10 [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
RANCID BEEF30 [hp_C]/mL
RHODODENDRON TOMENTOSUM LEAFY TWIG6 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii7S82P3R43Z, O80TY208ZW, 41LZ22DD4N, 18E7415PXQ, 3Y5X6RT823, Q28R5GF371, VB06AV5US8, 6H89ZY31MR, IDB0NAZ6AI, 3POA0Q644U, XK4IUX8MNB, VSW71SS07I, XJJ7QA858R, 29SUH5R3HU, 877L01IZ0P

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

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