FDA.reportPublic FDA data

Sciatica Back

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:03:58

Label at a glance#

ProductSciatica Back
Active ingredientAconitum Napellus, Ammonium Benzoate, Arsenic Trioxide, Benzoic Acid, Bryonia Alba Root, Causticum, Cinchona Officinalis Bark, Pseudognaphalium Obtusifolium, Iris Versicolor Root, Potassium Iodide, Ledum Palustre Twig, Lithium Carbonate, Strychnos Nux-vomica Seed, Phytolacca Americana Root, Toxicodendron Pubescens Leaf, Ruta Graveolens Flowering Top, Sambucus Nigra Flowering Top, Strychnine, Hypericum Perforatum, Urtica Urens, Colchicum Autumnale Bulb
Label structure10 sections

Label contents#

Full prescribing information#

PRODUCT NAME & INDICATIONS SECTION

INDICATIONS & USAGE SECTION

Sciatica~Back Care   Formulated for associated symptoms such as inflammation, sharp or throbbing pain, paresthesia and discomfort.

DIRECTION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 6 to 11, give 3 drops) as needed or as directed by a healthcare professional.

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Aconitum nap. 20x, Ammonium benzoicum 20x, Arsenicum alb. 20x, Benzoicum acidum 20x, Bryonia 20x, Causticum 20x, Cinchona 20x, Colchicum 20x, Gnaphalium polycephalum 20x, Iris versicolor 20x, Kali iod. 20x, Ledum 20x, Lithium carb. 20x, Nux vom. 20x, Phytolacca 20x, Rhus toxicodendron 20x, Ruta 20x, Sambucus nig. 20x, Strychninum 20x, Hypericum 8x, Urtica ur. 8x, Hypericum 3x, Urtica ur. 3x.

PURPOSE SECTION

ABUSE SECTION

Formulated for associated symptoms such as inflammation, sharp or throbbing pain, paresthesia and discomfort.

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: Do not use if tamper - evident seal is broken or missing. Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days. Keep out of reach of children.

OTC - PREGNANCY OR BREAST FEEDING SECTION

Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days

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
b3053bb1-353b-4a0b-bca5-28fe7228957cProduct name220250124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
8ce6e144-236f-b7be-f690-f06e0c8c6bd3Product name220170725
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
f09af6ee-c6dd-d0ce-77ad-93508bcdacedProduct name420161205

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4480-12020-01-31C16284748780-19d75b9d0-5bc6-f424-e053-dadaa90a57ceSciatica Back

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4480-1Sciatica Back29.57 mL in 1 BOTTLE, GLASSLIQUID29.571

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4480SCIATICA BACK (ACONITUM NAP., AMMONIUM BENZOICUM, ARSENICUM ALB., BENZOICUM ACIDUM, BRYONIA, CAUSTICUM, CINCHONA, COLCHICUM, GNAPHALIUM POLYCEPHALUM, IRIS VERSICOLOR, KALI IOD., LEDUM, LITHIUM CARB., NUX VOM., PHYTOLACCA, RHUS TOXICODENDRON, RUTA, SAMBUCUS NIG., STRYCHNINUM, HYPERICUM, URTICA UR., HYPERICUM, URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]1Legacy NDC, 1 package rows20120914_7682287b-c982-572b-78fc-2175198f7ef3.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Aconitum NapellusACTIVE INGREDIENTU0NQ8555JD1
Ammonium BenzoateACTIVE INGREDIENTAC80WD7GPF1
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO1
Benzoic AcidACTIVE INGREDIENT8SKN0B0MIM1
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B1
CausticumACTIVE INGREDIENTDD5FO1WKFU1
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB1
Colchicum Autumnale BulbACTIVE INGREDIENT993QHL78E61
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB1
Iris Versicolor RootACTIVE INGREDIENTX43D4L3DQC1
Ledum Palustre TwigACTIVE INGREDIENT877L01IZ0P1
Lithium CarbonateACTIVE INGREDIENT2BMD2GNA4V1
Phytolacca Americana RootACTIVE INGREDIENT11E6VI8VEG1
Potassium IodideACTIVE INGREDIENT1C4QK22F9J1
Pseudognaphalium ObtusifoliumACTIVE INGREDIENT36XQ854NWW1
Ruta Graveolens Flowering TopACTIVE INGREDIENTN94C2U587S1
Sambucus Nigra Flowering TopACTIVE INGREDIENTCT03BSA18U1
StrychnineACTIVE INGREDIENTH9Y79VD43J1
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139191
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A1
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF91
Aconitum NapellusACTIVE MOIETYU0NQ8555JD1
Ammonium BenzoateACTIVE MOIETYAC80WD7GPF1
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV1
Benzoic AcidACTIVE MOIETY8SKN0B0MIM1
Bryonia Alba RootACTIVE MOIETYT7J046YI2B1
CausticumACTIVE MOIETYDD5FO1WKFU1
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB1
Colchicum Autumnale BulbACTIVE MOIETY993QHL78E61
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB1
Iodide IonACTIVE MOIETY09G4I6V86Q1
Iris Versicolor RootACTIVE MOIETYX43D4L3DQC1
Ledum Palustre TwigACTIVE MOIETY877L01IZ0P1
Lithium CationACTIVE MOIETY8H8Z5UER661
Phytolacca Americana RootACTIVE MOIETY11E6VI8VEG1
Pseudognaphalium ObtusifoliumACTIVE MOIETY36XQ854NWW1
Ruta Graveolens Flowering TopACTIVE MOIETYN94C2U587S1
Sambucus Nigra Flowering TopACTIVE MOIETYCT03BSA18U1
StrychnineACTIVE MOIETYH9Y79VD43J1
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139191
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A1
Urtica UrensACTIVE MOIETYIHN2NQ5OF91
AlcoholINACTIVE INGREDIENT3K9958V90M1

Products#

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

DailyMed product names page 1 of 1 · 27 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-448055714-4480-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
Aconitum NapellusU0NQ8555JDACTIB
Ammonium BenzoateAC80WD7GPFACTIB
Arsenic TrioxideS7V92P67HOACTIB
Benzoic Acid8SKN0B0MIMACTIB
Bryonia Alba RootT7J046YI2BACTIB
CausticumDD5FO1WKFUACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Pseudognaphalium Obtusifolium36XQ854NWWACTIB
Iris Versicolor RootX43D4L3DQCACTIB
Potassium Iodide1C4QK22F9JACTIB
Ledum Palustre Twig877L01IZ0PACTIB
Lithium Carbonate2BMD2GNA4VACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Phytolacca Americana Root11E6VI8VEGACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Ruta Graveolens Flowering TopN94C2U587SACTIB
Sambucus Nigra Flowering TopCT03BSA18UACTIB
StrychnineH9Y79VD43JACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Urtica UrensIHN2NQ5OF9ACTIB
Colchicum Autumnale Bulb993QHL78E6ACTIB
Alcohol3K9958V90MIACT

Source Document#

Source XML · Source PDF

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
8f216336-7446-38b4-4710-a6df2a51c7fd7682287b-c982-572b-78fc-2175198f7ef32011-06-01WarningsExact identifier
spl id: 8f216336-7446-38b4-4710-a6df2a51c7fd
spl set id: 7682287b-c982-572b-78fc-2175198f7ef3

Reported adverse events (FAERS/openFDA)#

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