FDA.reportPublic FDA data

Edema

Manufacturer
Newton Laboratories, Inc.
Effective date
2011-06-01
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:05:29

Label at a glance#

ProductEdema
Active ingredientMicrurus Corallinus Venom, Apis Mellifera, Arsenic Trioxide, Lytta Vesicatoria, Cinchona Officinalis Bark, Colchicum Autumnale Bulb, Convallaria Majalis, Crotalus Horridus Horridus Venom, Digitalis, Juniperus Communis Fruit, Lachesis Muta Venom, Mercury, Naja Naja Venom, Sodium Carbonate, Sodium Sulfate, Toxicodendron Pubescens Leaf, Sambucus Nigra Flowering Top, Strophanthus Hispidus Seed, Thuja Occidentalis Leafy Twig, Vipera Berus Venom, Echinacea, Unspecified, Arctium Lappa Root, Solidago Virgaurea Flowering Top, Taraxacum Officinale, Urtica Urens
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS & USAGE SECTION

Edema  Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.      

DOSAGE & ADMINISTRATION SECTION

DOSAGE & ADMINISTRATION SECTION

Directions:  ORAL USE ONLY - SHAKE WELL.  Ages 12 and up, take 6 drops orally (ages 0 to 11, give 3 drops) one to four times daily or as directed by a healthcare professional.                       

ACTIVE INGREDIENT SECTION

OTC - ACTIVE INGREDIENT SECTION

Elaps corallinus 35x, Apis mel.15x, Arsenicum alb. 15x, Cantharis 15x, Cinchona 15x, Colchicum 15x, Convallaria 15x, Crotalus horridus 15x, Digitalis 15x, Juniperus com 15x, Lachesis 15x, Merc. viv. 15x, Naja 15x, Nat. carb. 15x, Nat. sulphuricum 15x, Rhus toxicodendron 15x, Sambucus nig. 15x, Strophanthus hispidus 15x, Thuja occ. 15x, Vipera berus 15x, Echinacea 8x, Lappa 8x, Solidago 8x, Taraxacum 8x, Urtica ur. 8x, Echinacea 3x, Lappa 3x, Solidago 3x, Taraxacum 3x, Urtica ur. 3x.           

PURPOSE SECTION

ABUSE SECTION

Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.

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. 

PREGNANCY OR BREAST FEEDING SECTION

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

KEEP OUT OF REACH OF CHILDREN SECTION

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
95250459-30e4-45c1-b08a-993044f49109Product name220250805
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55714-4542-12020-01-31C16284748780-19d75b9cf-f23f-f424-e053-dadaa90a57ceEdema
55714-4542-22020-01-31C16284748780-19d75b9cf-f23f-f424-e053-dadaa90a57ceEdema

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4542-1Edema29.57 mL in 1 BOTTLE, GLASSLIQUID29.573
55714-4542-2Edema59.14 mL in 1 BOTTLE, GLASSLIQUID59.143

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4542EDEMA (ELAPS CORALLINUS , APIS MEL., ARSENICUM ALB. , CANTHARIS, CINCHONA , COLCHICUM , CONVALLARIA , CROTALUS HORRIDUS , DIGITALIS , JUNIPERUS COM , LACHESIS , MERC. VIV. , NAJA , NAT. CARB. , NAT. SULPHURICUM , RHUS TOXICODENDRON , SAMBUCUS NIG. , STROPHANTHUS HISPIDUS , THUJA OCC. , VIPERA BERUS , ECHINACEA , LAPPA , SOLIDAGO , TARAXACUM , URTICA UR.) LIQUID [NEWTON LABORATORIES, INC.]3Legacy NDC, 2 package rows20140211_db7ac73a-e508-6b09-5bfc-5cfd0abb5e3e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Apis MelliferaACTIVE INGREDIENT7S82P3R43Z3
Arctium Lappa RootACTIVE INGREDIENT597E9BI3Z33
Arsenic TrioxideACTIVE INGREDIENTS7V92P67HO3
Cinchona Officinalis BarkACTIVE INGREDIENTS003A158SB3
Colchicum Autumnale BulbACTIVE INGREDIENT993QHL78E63
Convallaria MajalisACTIVE INGREDIENTQHH4HVF5QE3
Crotalus Horridus Horridus VenomACTIVE INGREDIENTYHA2XLJ9563
DigitalisACTIVE INGREDIENTF1T8QT9U8B3
Echinacea, UnspecifiedACTIVE INGREDIENT4N9P6CC1DX3
Juniperus Communis FruitACTIVE INGREDIENTO84B5194RL3
Lachesis Muta VenomACTIVE INGREDIENTVSW71SS07I3
Lytta VesicatoriaACTIVE INGREDIENT3Q034RO3BT3
MercuryACTIVE INGREDIENTFXS1BY2PGL3
Micrurus Corallinus VenomACTIVE INGREDIENTV0S6H369803
Naja Naja VenomACTIVE INGREDIENTZZ4AG7L7VM3
Sambucus Nigra Flowering TopACTIVE INGREDIENTCT03BSA18U3
Sodium CarbonateACTIVE INGREDIENT45P3261C7T3
Sodium SulfateACTIVE INGREDIENT0YPR65R21J3
Solidago Virgaurea Flowering TopACTIVE INGREDIENT5405K23S503
Strophanthus Hispidus SeedACTIVE INGREDIENTMO892VI77K3
Taraxacum OfficinaleACTIVE INGREDIENT39981FM3753
Thuja Occidentalis Leafy TwigACTIVE INGREDIENT1NT28V93973
Toxicodendron Pubescens LeafACTIVE INGREDIENT6IO182RP7A3
Urtica UrensACTIVE INGREDIENTIHN2NQ5OF93
Vipera Berus VenomACTIVE INGREDIENT0ORO6NCA4M3
Apis MelliferaACTIVE MOIETY7S82P3R43Z3
Arctium Lappa RootACTIVE MOIETY597E9BI3Z33
Arsenic Cation (3+)ACTIVE MOIETYC96613F5AV3
Carbonate IonACTIVE MOIETY7UJQ5OPE7D3
Cinchona Officinalis BarkACTIVE MOIETYS003A158SB3
Colchicum Autumnale BulbACTIVE MOIETY993QHL78E63
Convallaria MajalisACTIVE MOIETYQHH4HVF5QE3
Crotalus Horridus Horridus VenomACTIVE MOIETYYHA2XLJ9563
DigitalisACTIVE MOIETYF1T8QT9U8B3
Echinacea, UnspecifiedACTIVE MOIETY4N9P6CC1DX3
Juniperus Communis FruitACTIVE MOIETYO84B5194RL3
Lachesis Muta VenomACTIVE MOIETYVSW71SS07I3
Lytta VesicatoriaACTIVE MOIETY3Q034RO3BT3
MercuryACTIVE MOIETYFXS1BY2PGL3
Micrurus Corallinus VenomACTIVE MOIETYV0S6H369803
Naja Naja VenomACTIVE MOIETYZZ4AG7L7VM3
Sambucus Nigra Flowering TopACTIVE MOIETYCT03BSA18U3
Sodium Sulfate AnhydrousACTIVE MOIETY36KCS0R7503
Solidago Virgaurea Flowering TopACTIVE MOIETY5405K23S503
Strophanthus Hispidus SeedACTIVE MOIETYMO892VI77K3
Taraxacum OfficinaleACTIVE MOIETY39981FM3753
Thuja Occidentalis Leafy TwigACTIVE MOIETY1NT28V93973
Toxicodendron Pubescens LeafACTIVE MOIETY6IO182RP7A3
Urtica UrensACTIVE MOIETYIHN2NQ5OF93
Vipera Berus VenomACTIVE MOIETY0ORO6NCA4M3
AlcoholINACTIVE INGREDIENT3K9958V90M3

Products#

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

DailyMed product names page 1 of 1 · 31 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55714-454255714-4542-1, 55714-4542-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Micrurus Corallinus VenomV0S6H36980ACTIB
Apis Mellifera7S82P3R43ZACTIB
Arsenic TrioxideS7V92P67HOACTIB
Lytta Vesicatoria3Q034RO3BTACTIB
Cinchona Officinalis BarkS003A158SBACTIB
Colchicum Autumnale Bulb993QHL78E6ACTIB
Convallaria MajalisQHH4HVF5QEACTIB
Crotalus Horridus Horridus VenomYHA2XLJ956ACTIB
DigitalisF1T8QT9U8BACTIB
Juniperus Communis FruitO84B5194RLACTIB
Lachesis Muta VenomVSW71SS07IACTIB
MercuryFXS1BY2PGLACTIB
Naja Naja VenomZZ4AG7L7VMACTIB
Sodium Carbonate45P3261C7TACTIB
Sodium Sulfate0YPR65R21JACTIB
Toxicodendron Pubescens Leaf6IO182RP7AACTIB
Sambucus Nigra Flowering TopCT03BSA18UACTIB
Strophanthus Hispidus SeedMO892VI77KACTIB
Thuja Occidentalis Leafy Twig1NT28V9397ACTIB
Vipera Berus Venom0ORO6NCA4MACTIB
Echinacea, Unspecified4N9P6CC1DXACTIB
Arctium Lappa Root597E9BI3Z3ACTIB
Solidago Virgaurea Flowering Top5405K23S50ACTIB
Taraxacum Officinale39981FM375ACTIB
Urtica UrensIHN2NQ5OF9ACTIB
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
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact 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
AlcoholALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSWAB / TOPICAL2250 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
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 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
AlcoholALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 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
AlcoholALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact 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
AlcoholALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/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
AlcoholALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
AlcoholALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact 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
c6955cda-507a-4d07-3927-3d5e2564335edb7ac73a-e508-6b09-5bfc-5cfd0abb5e3e2011-06-01WarningsExact identifier
spl id: c6955cda-507a-4d07-3927-3d5e2564335e
spl set id: db7ac73a-e508-6b09-5bfc-5cfd0abb5e3e

Reported adverse events (FAERS/openFDA)#

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