FDA.reportPublic FDA data

Natural Response

Manufacturer
Newton Laboratories, Inc.
Effective date
2014-11-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:06:14

Label at a glance#

ProductNatural Response
Active ingredientAconitum Napellus, Arnica Montana, Arsenic Trioxide, Bryonia Alba Root, Echinacea, Unspecified, Ledum Palustre Twig, Agkistrodon Contortrix Venom, Crotalus Durissus Terrificus Venom, Crotalus Horridus Horridus Venom, Lachesis Muta Venom, Mercuric Chloride, Naja Naja Venom, Phosphorus, Agkistrodon Piscivorus Venom, Vipera Berus Venom, Micrurus Corallinus Venom, Heloderma Suspectum Venom
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for symptoms associated with injuries, bites and infections such as restlessness, bleeding, pain, nausea, vomiting, swelling, trembling and confusion.

DOSAGE & ADMINISTRATION SECTION

Directions:  Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) as needed or as directed by a health professional.  Sensitive persons begin with 1 drop and gradually increase to full dose.  Warning:  For use as an interim therapy.  Seek professional medical intervention for severe injuries, bites or infections.

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 10x, Arnica 10x, Arsenicum alb. 10x, Bryonia 10x, Echinacea 10x, Ledum 10x, Cenchris 15x, Crotalus casc. 15x, Crotalus hor. 15x, Lachesis 15x, Merc. corros. 15x, Naja 15x, Phos. 15x, Toxicophis 15x, Vipera 15x, Elaps cor. 30x, Heloderma 30x.

OTC - PURPOSE SECTION

Formulated for symptoms associated with injuries, bites and infections such as restlessness, bleeding, pain, nausea, vomiting, swelling, trembling and confusion.

INACTIVE INGREDIENT SECTION

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

QUESTIONS SECTION

OTC - QUESTIONS SECTION

www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA 30012
Questions?  1.800.448.7256 

WARNINGS SECTION

Warning:  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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2366-12020-01-31C16284748780-19d75b9d0-0e47-f424-e053-dadaa90a57ceNatural Response
55714-2366-22020-01-31C16284748780-19d75b9d0-0e47-f424-e053-dadaa90a57ceNatural Response

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2366-1Natural Response30 mL in 1 BOTTLE, GLASSLIQUID301
55714-2366-2Natural Response59 mL in 1 BOTTLE, GLASSLIQUID591

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2366NATURAL RESPONSE (ACONITUM NAP., ARNICA, ARSENICUM ALB., BRYONIA, ECHINACEA, LEDUM, CENCHRIS, CROTALUS CASC. CROTALUS HOR., LACHESIS, MERC. CORROS., NAJA, PHOS., TOXICOPHIS, VIPERA, ELAPS COR., HELODERMA) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 2 package rows20141204_ae0abe72-d7cd-e805-fc1e-49e40753f3a9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Agkistrodon Contortrix VenomACTIVE INGREDIENT3BKX485ZP01
Agkistrodon Piscivorus VenomACTIVE INGREDIENTX9V1Q8U1501
Arnica MontanaACTIVE INGREDIENTO80TY208ZW1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
Crotalus Durissus Terrificus VenomACTIVE INGREDIENT2XF6I0446G1
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9561
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX1
Heloderma Suspectum VenomACTIVE INGREDIENTKV57S963671
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I1
Ledum Palustre TwigACTIVE INGREDIENT877L01IZ0P1
Mercuric ChlorideACTIVE INGREDIENT53GH7MZT1R1
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369801
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM1
PhosphorusACTIVE INGREDIENT27YLU75U4W1
Vipera Berus VenomACTIVE INGREDIENT0ORO6NCA4M1
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Agkistrodon Contortrix VenomACTIVE MOIETY3BKX485ZP01
Agkistrodon Piscivorus VenomACTIVE MOIETYX9V1Q8U1501
Arnica MontanaACTIVE MOIETYO80TY208ZW1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
Crotalus Durissus Terrificus VenomACTIVE MOIETY2XF6I0446G1
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9561
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX1
Heloderma Suspectum VenomACTIVE MOIETYKV57S963671
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I1
Ledum Palustre TwigACTIVE MOIETY877L01IZ0P1
Mercuric CationACTIVE MOIETYED30FJ8Y421
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369801
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM1
PhosphorusACTIVE MOIETY27YLU75U4W1
Vipera Berus VenomACTIVE MOIETY0ORO6NCA4M1
AlcoholINACTIVE INGREDIENT3K9958V90M1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-236655714-2366-1, 55714-2366-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Arnica MontanaO80TY208ZWACTIB
Arsenic TrioxideS7V92P67HOACTIM
Bryonia Alba RootT7J046YI2BACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Ledum Palustre Twig877L01IZ0PACTIB
Agkistrodon Contortrix Venom3BKX485ZP0ACTIB
Crotalus Durissus Terrificus Venom2XF6I0446GACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Mercuric Chloride53GH7MZT1RACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Phosphorus27YLU75U4WACTIB
Agkistrodon Piscivorus VenomX9V1Q8U150ACTIB
Vipera Berus Venom0ORO6NCA4MACTIB
Micrurus Corallinus VenomV0S6H36980ACTIB
Heloderma Suspectum VenomKV57S96367ACTIB
Alcohol3K9958V90MIACT
Water059QF0KO0RIACT

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
4120deb4-3543-419f-7394-1eb8208297adae0abe72-d7cd-e805-fc1e-49e40753f3a92014-11-10WarningsExact identifier
spl id: 4120deb4-3543-419f-7394-1eb8208297ad
spl set id: ae0abe72-d7cd-e805-fc1e-49e40753f3a9

Reported adverse events (FAERS/openFDA)#

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