FDA.reportPublic FDA data

Leg Cramps - Swelling

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-03-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:04:49

Label at a glance#

ProductLeg Cramps - Swelling
Active ingredientMicrurus Corallinus Venom, Silver Nitrate, Bryonia Alba Root, Oyster Shell Calcium Carbonate, Crude, Citrullus Colocynthis Fruit Pulp, Convallaria Majalis, Crotalus Horridus Horridus Venom, Copper, Digitalis, Gelsemium Sempervirens Root, Hypericum Perforatum, Potassium Carbonate, Lachesis Muta Venom, Lathyrus Sativas Seed, Lilium Lancifolium Whole Flowering, Magnesium Phosphate, Dibasic Trihydrate, Strychnos Nux-vomica Seed, Toxicodendron Pubescens Leaf, Silicon Dioxide, Datura Stramonium, Veratrum Viride Root, Echinacea, Unspecified
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Leg Cramps - Swelling  Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.

DOSAGE & ADMINISTRATION SECTION

Directions: ORAL USE ONLY - SHAKE WELL.   Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) as needed or as directed by a healthcare professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 30x, Arg. nit. 15x, Bryonia 15x, Calc. carb. 15x, Colocynthis 15x, Convallaria 15x, Crotalus horridus 15x, Cuprum met. 15x, Digitalis 15x, Gelsemium 15x, Hypericum 15x, Kali carb. 15x, Lachesis 15x, Lathyrus sativus 15x, Lilium 15x, Mag. phos. 15x, Nux vom. 15x, Rhus toxicodendron 15x, Silicea 15x, Stramonium 15x, Veratrum viride 15x, Echinacea 3x.

OTC - PURPOSE SECTION

Formulated for associated symptoms such as pain, cramping, swelling due to inflammation, stiffness and numbness in the legs and feet.

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
6e3c022f-0786-43f1-8857-edff89d5153fProduct name120260309
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
95250459-30e4-45c1-b08a-993044f49109Product name220250805
efd58652-cb8f-4018-91ca-4b0eb2ff729fProduct name720240226
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
2641ccb3-721d-4fbf-9f2f-ca2f18157a62Product name320210309
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
e7e58cd3-cacb-49df-8d34-1ee335614abbProduct name120150609
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
6cca4355-1206-91f7-02de-17eef38a8622Product name120140508
751c581a-bf64-2fd7-b3ec-ca02c83e4a00Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-2294-02020-01-31C16284748780-19d75b9d0-1339-f424-e053-dadaa90a57ceLeg Cramps - Swelling
55714-2294-12020-01-31C16284748780-19d75b9d0-1339-f424-e053-dadaa90a57ceLeg Cramps - Swelling
55714-2294-22020-01-31C16284748780-19d75b9d0-1339-f424-e053-dadaa90a57ceLeg Cramps - Swelling

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2294-0Leg Cramps - Swelling.5 mL in 1 BOTTLE, GLASSLIQUID.52
55714-2294-1Leg Cramps - Swelling29.57 mL in 1 BOTTLE, GLASSLIQUID29.572
55714-2294-2Leg Cramps - Swelling59.14 mL in 1 BOTTLE, GLASSLIQUID59.142

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2294LEG CRAMPS - SWELLING (ELAPS CORALLINUS, ARG. NIT., BRYONIA, CALC. CARB., COLOCYNTHIS, CONVALLARIA, CROTALUS HORRIDUS, CUPRUM MET., DIGITALIS, GELSEMIUM, HYPERICUM, KALI CARB., LACHESIS, LATHYRUS SATIVUS, LILIUM, MAG. PHOS., NUX VOM., RHUS TOXICODENDRON, SILICEA, STRAMONIUM, VERATRUM VIRIDE, ECHINACEA) LIQUID [NEWTON LABORATORIES, INC.]2Legacy NDC, 3 package rows20130806_8486896f-f74f-513d-a5d7-37522cc5e5a9.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Bryonia Alba RootACTIVE INGREDIENTT7J046YI2B2
Citrullus Colocynthis Fruit PulpACTIVE INGREDIENT23H32AOH172
Convallaria MajalisACTIVE INGREDIENTQHH4HVF5QE2
CopperACTIVE INGREDIENT789U1901C52
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9562
Datura StramoniumACTIVE INGREDIENTG6W4F0V8Z32
DigitalisACTIVE INGREDIENTF1T8QT9U8B2
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX2
Gelsemium Sempervirens RootACTIVE INGREDIENT639KR60Q1Q2
Hypericum PerforatumACTIVE INGREDIENTXK4IUX8MNB2
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I2
Lathyrus Sativas SeedACTIVE INGREDIENT8VP54WOT4I2
Lilium Lancifolium Whole FloweringACTIVE INGREDIENTX67Z2963PI2
Magnesium Phosphate, Dibasic TrihydrateACTIVE INGREDIENTHF539G9L3Q2
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369802
Oyster Shell Calcium Carbonate, CrudeACTIVE INGREDIENT2E32821G6I2
Potassium CarbonateACTIVE INGREDIENTBQN1B9B9HA2
Silicon DioxideACTIVE INGREDIENTETJ7Z6XBU42
Silver NitrateACTIVE INGREDIENT95IT3W8JZE2
Strychnos Nux-vomica SeedACTIVE INGREDIENT269XH139192
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A2
Veratrum Viride RootACTIVE INGREDIENT197B3Q7T5Q2
Bryonia Alba RootACTIVE MOIETYT7J046YI2B2
Carbonate IonACTIVE MOIETY7UJQ5OPE7D2
Citrullus Colocynthis Fruit PulpACTIVE MOIETY23H32AOH172
Convallaria MajalisACTIVE MOIETYQHH4HVF5QE2
CopperACTIVE MOIETY789U1901C52
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9562
Datura StramoniumACTIVE MOIETYG6W4F0V8Z32
DigitalisACTIVE MOIETYF1T8QT9U8B2
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX2
Gelsemium Sempervirens RootACTIVE MOIETY639KR60Q1Q2
Hypericum PerforatumACTIVE MOIETYXK4IUX8MNB2
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I2
Lathyrus Sativas SeedACTIVE MOIETY8VP54WOT4I2
Lilium Lancifolium Whole FloweringACTIVE MOIETYX67Z2963PI2
Magnesium CationACTIVE MOIETYT6V3LHY8382
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369802
Oyster Shell Calcium Carbonate, CrudeACTIVE MOIETY2E32821G6I2
Silicon DioxideACTIVE MOIETYETJ7Z6XBU42
Silver CationACTIVE MOIETY57N7B0K90A2
Strychnos Nux-vomica SeedACTIVE MOIETY269XH139192
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A2
Veratrum Viride RootACTIVE MOIETY197B3Q7T5Q2
AlcoholINACTIVE INGREDIENT3K9958V90M2

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-229455714-2294-1, 55714-2294-2, 55714-2294-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
Micrurus Corallinus VenomV0S6H36980ACTIB
Silver Nitrate95IT3W8JZEACTIB
Bryonia Alba RootT7J046YI2BACTIB
Oyster Shell Calcium Carbonate, Crude2E32821G6IACTIB
Citrullus Colocynthis Fruit Pulp23H32AOH17ACTIB
Convallaria MajalisQHH4HVF5QEACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
Copper789U1901C5ACTIB
DigitalisF1T8QT9U8BACTIB
Gelsemium Sempervirens Root639KR60Q1QACTIB
Hypericum PerforatumXK4IUX8MNBACTIB
Potassium CarbonateBQN1B9B9HAACTIB
Lachesis Muta VenomVSW71SS07IACTIB
Lathyrus Sativas Seed8VP54WOT4IACTIB
Lilium Lancifolium Whole FloweringX67Z2963PIACTIB
Magnesium Phosphate, Dibasic TrihydrateHF539G9L3QACTIB
Strychnos Nux-vomica Seed269XH13919ACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Silicon DioxideETJ7Z6XBU4ACTIB
Datura StramoniumG6W4F0V8Z3ACTIB
Veratrum Viride Root197B3Q7T5QACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Alcohol3K9958V90MIACT

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
AlcoholALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %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
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/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
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact 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
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 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
60d44f14-0b8c-71cd-b2fc-72f33ef2dfd88486896f-f74f-513d-a5d7-37522cc5e5a92011-03-01WarningsExact identifier
spl id: 60d44f14-0b8c-71cd-b2fc-72f33ef2dfd8
spl set id: 8486896f-f74f-513d-a5d7-37522cc5e5a9

Reported adverse events (FAERS/openFDA)#

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