FDA.reportPublic FDA data

Flea - Bug Bites

Manufacturer
Newton Laboratories, Inc.
Effective date
2019-01-14
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 00:11:37

Label at a glance#

ProductFlea - Bug Bites
Active ingredientRancid Beef, Apis Mellifera, Araneus Diadematus, Arnica Montana, Arsenic Trioxide, Azadirachta Indica Bark, Bryonia Alba Root, Dieffenbachia Seguine, Calendula Officinalis Flowering Top, Formica Rufa, Grindelia Hirsutula Flowering Top, Hypericum Perforatum, Lachesis Muta Venom, Latrodectus Mactans, Ledum Palustre Twig, Daphne Mezereum Bark, Strychnos Nux-vomica Seed, Pulex Irritans, Toxicodendron Pubescens Leaf, Citharacanthus Spinicrus, Lycosa Tarantula, Theridion Curassavicum, Cedar Leaf Oil, Vespa Crabro, Echinacea, Unspecified, Hamamelis Virginiana Root Bark/stem Bark, Solidago Virgaurea Flowering Top
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with bites and stings such as inflammation, burning, itching, swelling and discomfort.

DOSAGE & ADMINISTRATION SECTION

Directions: Pets, under 50 lbs., give 3 drops by mouth (50 to 500 lbs. - 6 drops,over 500 lbs. - 1/2 teaspoon) as needed or as directed by a health professional. Place in mouth or purified water.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 6x, Hamamelis 6x, Solidago 6x, Apis mel. 15x, Aranea 15x, Arnica 15x, Arsenicum alb. 15x, Azadirachta indica 15x, Bryonia 15x, Caladium seguinum 15x, Calendula 15x, Formica 15x, Grindelia 15x, Hypericum 15x, Lachesis 15x, Latrodectus mac. 15x, Ledum 15x, Mezereum 15x, Nux vom. 15x, Pulex irr. 15x, Rhus tox. 15x, Tarentula cub.15x, Tarentula hisp. 15x, Theridion 15x, Thuja occ. 15x, Vespa 15x, Pyrogenium 30x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with bites and stings such as inflammation, burning, itching, swelling and discomfort.

INACTIVE INGREDIENT SECTION

Inactive Ingredients: USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%. 

QUESTIONS SECTION

OTC - QUESTIONS SECTION

newtonlabs.net  Questions?  1.800.448.7256 
Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30013

WARNINGS SECTION

WARNINGS:  Keep out of reach of children. Do not use if tamper-evident seal is broken or missing. If symptoms worsen or persist for more than a few days, consult a doctor.  If pregnant or breast-feeding, ask a doctor before use.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a doctor before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

PACKAGE LABEL.PRINCIPAL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label
package label
package label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4259FLEA - BUG BITES (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.]3Unmatched20190918_7fb812b3-47af-5aa1-3bee-6500290c9f4b.zip
55714-4287FLEA - BUG BITES (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.]3Unmatched20190918_7fb812b3-47af-5aa1-3bee-6500290c9f4b.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z1
Araneus DiadematusACTIVE INGREDIENT6T6CO7R3Z51
Arnica MontanaACTIVE INGREDIENTO80TY208ZW1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Azadirachta Indica BarkACTIVE INGREDIENTG580B439YI1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Calendula Officinalis Flowering TopACTIVE INGREDIENT18E7415PXQ1
Cedar Leaf OilACTIVE INGREDIENTBJ169U4NLG1
Citharacanthus SpinicrusACTIVE INGREDIENT3Y5X6RT8231
Daphne Mezereum BarkACTIVE INGREDIENTX2N6E405GV1
Dieffenbachia SeguineACTIVE INGREDIENT01800C6E6B1
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Formica RufaACTIVE INGREDIENT55H0W83JO51
Grindelia Hirsutula Flowering TopACTIVE INGREDIENTIDB0NAZ6AI1
Hamamelis Virginiana Root Bark/stem BarkACTIVE INGREDIENTT7S323PKJS1
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Latrodectus MactansACTIVE INGREDIENTXJJ7QA858R1
Ledum Palustre TwigACTIVE INGREDIENT877L01IZ0P1
Lycosa TarantulaACTIVE INGREDIENT86M454L2TT1
Pulex IrritansACTIVE INGREDIENTL63DD62R8R1
Rancid BeefACTIVE INGREDIENT29SUH5R3HU1
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S501
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Theridion CurassavicumACTIVE INGREDIENT9Z8D3HEM8L1
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Vespa CrabroACTIVE INGREDIENTK3ALM8S49H1
Apis MelliferaACTIVE MOIETY7S82P3R43Z1
Araneus DiadematusACTIVE MOIETY6T6CO7R3Z51
Arnica MontanaACTIVE MOIETYO80TY208ZW1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Azadirachta Indica BarkACTIVE MOIETYG580B439YI1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Calendula Officinalis Flowering TopACTIVE MOIETY18E7415PXQ1
Cedar Leaf OilACTIVE MOIETYBJ169U4NLG1
Citharacanthus SpinicrusACTIVE MOIETY3Y5X6RT8231
Daphne Mezereum BarkACTIVE MOIETYX2N6E405GV1
Dieffenbachia SeguineACTIVE MOIETY01800C6E6B1
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Formica RufaACTIVE MOIETY55H0W83JO51
Grindelia Hirsutula Flowering TopACTIVE MOIETYIDB0NAZ6AI1
Hamamelis Virginiana Root Bark/stem BarkACTIVE MOIETYT7S323PKJS1
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Latrodectus MactansACTIVE MOIETYXJJ7QA858R1
Ledum Palustre TwigACTIVE MOIETY877L01IZ0P1
Lycosa TarantulaACTIVE MOIETY86M454L2TT1
Pulex IrritansACTIVE MOIETYL63DD62R8R1
Rancid BeefACTIVE MOIETY29SUH5R3HU1
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S501
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Theridion CurassavicumACTIVE MOIETY9Z8D3HEM8L1
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Vespa CrabroACTIVE MOIETYK3ALM8S49H1
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-425955714-4259-1, 55714-4259-2, 55714-4259-0
55714-428755714-4287-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 2 · 57 matching rows.

Name, UNII, Kind table
NameUNIIKind
Rancid Beef29SUH5R3HUACTIB
Apis Mellifera7S82P3R43ZACTIB
Araneus Diadematus6T6CO7R3Z5ACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Azadirachta Indica BarkG580B439YIACTIB
Bryonia Alba RootT7J046YI2BACTIB
Dieffenbachia Seguine01800C6E6BACTIB
Calendula Officinalis Flowering Top18E7415PXQACTIB
Formica Rufa55H0W83JO5ACTIB
Grindelia Hirsutula Flowering TopIDB0NAZ6AIACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Latrodectus MactansXJJ7QA858RACTIB
Ledum Palustre Twig877L01IZ0PACTIB
Daphne Mezereum BarkX2N6E405GVACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Pulex IrritansL63DD62R8RACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Citharacanthus Spinicrus3Y5X6RT823ACTIB
Lycosa Tarantula86M454L2TTACTIB
Theridion Curassavicum9Z8D3HEM8LACTIB
Cedar Leaf OilBJ169U4NLGACTIB
Vespa CrabroK3ALM8S49HACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Hamamelis Virginiana Root Bark/stem BarkT7S323PKJSACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Alcohol3K9958V90MIACT
Rancid Beef29SUH5R3HUACTIB
Apis Mellifera7S82P3R43ZACTIB
Araneus Diadematus6T6CO7R3Z5ACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIB
Azadirachta Indica BarkG580B439YIACTIB
Bryonia Alba RootT7J046YI2BACTIB
Dieffenbachia Seguine01800C6E6BACTIB
Calendula Officinalis Flowering Top18E7415PXQACTIB
Formica Rufa55H0W83JO5ACTIB
Grindelia Hirsutula Flowering TopIDB0NAZ6AIACTIB
Hypericum PerforatumXK4IUX8MNBACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates

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 · 5 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
PyrogeniumRANCID BEEFLaboratoires Boiron4ec6b690-bf64-11e7-81ee-424c583030312023-11-08WarningsName fallback
generic name: RANCID BEEF
PYROGENIUMRANCID BEEFBoiron09a97a76-5caa-fcaf-e063-6294a90ab2482023-11-08Name fallback
generic name: RANCID BEEF
PyrogeniumRANCID BEEFBoiron09aa14d9-4048-2f04-e063-6294a90af5ec2023-11-08Name fallback
generic name: RANCID BEEF
PyrogeniumRANCID BEEFBoiron09aa5b10-da76-6d61-e063-6294a90a72b92023-11-08Name fallback
generic name: RANCID BEEF
PyrogeniumRANCID BEEFLaboratoires Boirone07f3730-7c6a-11e6-87b7-424c583030312023-03-23WarningsName fallback
generic name: RANCID BEEF

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.