FDA.reportPublic FDA data

Edema

Manufacturer
Newton Laboratories, Inc.
Effective date
2020-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:13:47

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, NAJA NAJA VENOM, DIGITALIS, LACHESIS MUTA VENOM, MERCURY, 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, JUNIPER BERRY
Label structure10 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

Formulated for smptoms such as skin discoloration, discomfort and swelling.

DOSAGE & ADMINISTRATION SECTION

Directions: Ages 12 and up, take 6 drops by mouth (ages 0 to 11, give 3 drops) one to four times daily or as directed by a health professional. Sensitive persons begin with 1 drop and gradually increase to full dose.

OTC - ACTIVE INGREDIENT SECTION

Equal parts of Echinacea 11x, Lappa 11x, Solidago 11x, Taraxacum 11x, Urtica ur. 11x, Apis mel. 20x, Arsenicum alb. 20x, Cantharis 20x, Cinchona 20x, Colchicum 20x, Convallaria 20x, Crotalus hor. 20x, Digitalis 20x, Juniperus com. 20x, Lachesis 20x, Merc. viv. 20x, Naja 20x, Nat. carb. 20x, Nat.sulphuricum 20x, Rhus tox. 20x, Sambucus nig. 20x, Strophanthus hisp. 20x, Thuja occ. 20x, Vipera 20x, Elaps 35x.

OTC - PURPOSE SECTION

Formulated for symptoms such as skin discoloration, discomfort and swelling.

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? 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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package labelpackage 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4812-1Edema30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4812EDEMA (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.]2Current NDC, Legacy NDC, 1 package rows20201204_98fbd4b0-43ac-098b-e053-2a95a90a6645.zip

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
55714-481255714-4812-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
MICRURUS CORALLINUS VENOMV0S6H36980ACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
LYTTA VESICATORIA3Q034RO3BTACTIB
CINCHONA OFFICINALIS BARKS003A158SBACTIB
COLCHICUM AUTUMNALE BULB993QHL78E6ACTIB
CONVALLARIA MAJALISQHH4HVF5QEACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
NAJA NAJA VENOMZZ4AG7L7VMACTIB
DIGITALISF1T8QT9U8BACTIB
LACHESIS MUTA VENOMVSW71SS07IACTIB
MERCURYFXS1BY2PGLACTIB
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
JUNIPER BERRYO84B5194RLACTIB

Source Document#

Source XML

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
EdemaELAPS 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.Newton Laboratories, Inc.98fbd4b0-43ac-098b-e053-2a95a90a66452020-12-03WarningsExact identifier
ndc (package): 55714-4812-1
ndc (product): 55714-4812
ndc11 (package): 55714481201
spl id: b5924b1f-3082-cd6e-e053-2a95a90ac950
spl set id: 98fbd4b0-43ac-098b-e053-2a95a90a6645

Reported adverse events (FAERS/openFDA)#

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