Edema
- 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 02:05:11
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Edema Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.
DOSAGE & ADMINISTRATION SECTION
Directions: Ages 12 and up, take 6 pellets orally (ages 0 to 11, give 3 pellets) one to four times daily or as directed by a healthcare professional. Under age 2, crush or dissolve pellets in purified water.
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
Formulated for symptoms associated with generalized or peripheral edema due to injury or various health conditions.
INACTIVE INGREDIENT SECTION
Inactive Ingredients: Gluten-free, non-GMO, beet-derived sucrose pellets.
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
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
Keep out of reach of children.
PACKAGE LABEL
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 95250459-30e4-45c1-b08a-993044f49109 | Product name | 2 | 20250805 |
| 63f39a63-5cd1-4016-bd86-2bbb0f6c3139 | Product name | 3 | 20240506 |
| e5a77e9c-c528-733a-173d-914a234c024b | Product name | 5 | 20240506 |
| 362d7abb-94e6-4c60-9a58-266894157713 | Product name | 1 | 20231023 |
| 9badc7be-250a-44ab-aa36-926af3f02679 | Product name | 1 | 20210527 |
| 816b97af-edc5-4060-aff1-b814bdbcad50 | Product name | 1 | 20190415 |
| 26acd337-b838-40ac-bcbc-05c3b81c8712 | Product name | 1 | 20170323 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4543-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-84af-f424-e053-dadaa90a57ce | Edema |
| 55714-4543-2 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-84af-f424-e053-dadaa90a57ce | Edema |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4543-1 | Edema | 28.35 g in 1 BOTTLE, GLASS | PELLET | 28.35 | 1 | |
| 55714-4543-2 | Edema | 56.7 g in 1 BOTTLE, GLASS | PELLET | 56.7 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4543 | EDEMA (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.) PELLET [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 2 package rows | 20131112_d090426e-7b68-c0f1-3105-bb911e642576.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Apis Mellifera | ACTIVE INGREDIENT | 7S82P3R43Z | 1 | |
| Arctium Lappa Root | ACTIVE INGREDIENT | 597E9BI3Z3 | 1 | |
| Arsenic Trioxide | ACTIVE INGREDIENT | S7V92P67HO | 1 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 1 | |
| Colchicum Autumnale Bulb | ACTIVE INGREDIENT | 993QHL78E6 | 1 | |
| Convallaria Majalis | ACTIVE INGREDIENT | QHH4HVF5QE | 1 | |
| Crotalus Horridus Horridus Venom | ACTIVE INGREDIENT | YHA2XLJ956 | 1 | |
| Digitalis | ACTIVE INGREDIENT | F1T8QT9U8B | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Juniperus Communis Fruit | ACTIVE INGREDIENT | O84B5194RL | 1 | |
| Lachesis Muta Venom | ACTIVE INGREDIENT | VSW71SS07I | 1 | |
| Lytta Vesicatoria | ACTIVE INGREDIENT | 3Q034RO3BT | 1 | |
| Mercury | ACTIVE INGREDIENT | FXS1BY2PGL | 1 | |
| Micrurus Corallinus Venom | ACTIVE INGREDIENT | V0S6H36980 | 1 | |
| Naja Naja Venom | ACTIVE INGREDIENT | ZZ4AG7L7VM | 1 | |
| Sambucus Nigra Flowering Top | ACTIVE INGREDIENT | CT03BSA18U | 1 | |
| Sodium Carbonate | ACTIVE INGREDIENT | 45P3261C7T | 1 | |
| Sodium Sulfate | ACTIVE INGREDIENT | 0YPR65R21J | 1 | |
| Solidago Virgaurea Flowering Top | ACTIVE INGREDIENT | 5405K23S50 | 1 | |
| Strophanthus Hispidus Seed | ACTIVE INGREDIENT | MO892VI77K | 1 | |
| Taraxacum Officinale | ACTIVE INGREDIENT | 39981FM375 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE INGREDIENT | 1NT28V9397 | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE INGREDIENT | 6IO182RP7A | 1 | |
| Urtica Urens | ACTIVE INGREDIENT | IHN2NQ5OF9 | 1 | |
| Vipera Berus Venom | ACTIVE INGREDIENT | 0ORO6NCA4M | 1 | |
| Apis Mellifera | ACTIVE MOIETY | 7S82P3R43Z | 1 | |
| Arctium Lappa Root | ACTIVE MOIETY | 597E9BI3Z3 | 1 | |
| Arsenic Cation (3+) | ACTIVE MOIETY | C96613F5AV | 1 | |
| Carbonate Ion | ACTIVE MOIETY | 7UJQ5OPE7D | 1 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 1 | |
| Colchicum Autumnale Bulb | ACTIVE MOIETY | 993QHL78E6 | 1 | |
| Convallaria Majalis | ACTIVE MOIETY | QHH4HVF5QE | 1 | |
| Crotalus Horridus Horridus Venom | ACTIVE MOIETY | YHA2XLJ956 | 1 | |
| Digitalis | ACTIVE MOIETY | F1T8QT9U8B | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Juniperus Communis Fruit | ACTIVE MOIETY | O84B5194RL | 1 | |
| Lachesis Muta Venom | ACTIVE MOIETY | VSW71SS07I | 1 | |
| Lytta Vesicatoria | ACTIVE MOIETY | 3Q034RO3BT | 1 | |
| Mercury | ACTIVE MOIETY | FXS1BY2PGL | 1 | |
| Micrurus Corallinus Venom | ACTIVE MOIETY | V0S6H36980 | 1 | |
| Naja Naja Venom | ACTIVE MOIETY | ZZ4AG7L7VM | 1 | |
| Sambucus Nigra Flowering Top | ACTIVE MOIETY | CT03BSA18U | 1 | |
| Sodium Sulfate Anhydrous | ACTIVE MOIETY | 36KCS0R750 | 1 | |
| Solidago Virgaurea Flowering Top | ACTIVE MOIETY | 5405K23S50 | 1 | |
| Strophanthus Hispidus Seed | ACTIVE MOIETY | MO892VI77K | 1 | |
| Taraxacum Officinale | ACTIVE MOIETY | 39981FM375 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE MOIETY | 1NT28V9397 | 1 | |
| Toxicodendron Pubescens Leaf | ACTIVE MOIETY | 6IO182RP7A | 1 | |
| Urtica Urens | ACTIVE MOIETY | IHN2NQ5OF9 | 1 | |
| Vipera Berus Venom | ACTIVE MOIETY | 0ORO6NCA4M | 1 | |
| Sucrose | INACTIVE INGREDIENT | C151H8M554 | 1 |
Products#
Every source-derived product name is available through these pages.
- Edema
- 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.
- Micrurus Corallinus Venom
- Apis Mellifera
- Arsenic Trioxide
- Arsenic Cation (3+)
- 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
- Carbonate Ion
- Sodium Sulfate
- Sodium Sulfate Anhydrous
- 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
- Sucrose
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4543 | 55714-4543-1, 55714-4543-2 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS | 2000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE / ORAL | 3568 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, EXTENDED RELEASE / ORAL | 619 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED / ORAL | 145 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, FOR SUSPENSION / INTRAVENOUS | 900 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, COATED / ORAL | 516.42 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 308 mg | ||
| Sucrose | SUCROSE | C151H8M554 | DROPS / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION / ORAL | 31885 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / BUCCAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | 9.4 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SUSPENSION, EXTENDED RELEASE / ORAL | 18790 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED, EXTENDED RELEASE / ORAL | 86 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / SUBLINGUAL | 109 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, EXTENDED RELEASE / ORAL | 284.54 mg | ||
| Sucrose | SUCROSE | C151H8M554 | PASTILLE / ORAL | 426 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUPPOSITORY / RECTAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTABLE, LIPOSOMAL / INTRAVENOUS | 7560 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, DELAYED RELEASE / ORAL | 295.33 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CONCENTRATE / ORAL | 4800 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / RECTAL | 35.42 %w/v | ||
| Sucrose | SUCROSE | C151H8M554 | LIQUID / ORAL | 37500 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, EMULSION / INTRAVENOUS | 970 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, COATED PELLETS / ORAL | 59.8 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION, EXTENDED RELEASE / ORAL | 5400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION/ DROPS / ORAL | 3750 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET / ORAL | 4249 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | 1 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE, FOR SOLUTION / ORAL | 42596 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SUSPENSION / ORAL | 40017 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / SUBCUTANEOUS | 47.75 mg | ||
| Sucrose | SUCROSE | C151H8M554 | LOZENGE / TRANSMUCOSAL | 1255 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / BUCCAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION / INTRAVENOUS | 1950 mg | ||
| Sucrose | SUCROSE | C151H8M554 | CAPSULE, DELAYED RELEASE / ORAL | 955 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SYRUP / ORAL | 46400 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 119.12 mg | ||
| Sucrose | SUCROSE | C151H8M554 | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| Sucrose | SUCROSE | C151H8M554 | TROCHE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | SOLUTION / ORAL | 70000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER / ORAL | 27768 mg | ||
| Sucrose | SUCROSE | C151H8M554 | GRANULE / ORAL | NA | ||
| Sucrose | SUCROSE | C151H8M554 | POWDER, FOR SOLUTION / ORAL | 38666 mg | ||
| Sucrose | SUCROSE | C151H8M554 | SUSPENSION / ORAL | 48209 mg | ||
| Sucrose | SUCROSE | C151H8M554 | TABLET, CHEWABLE / ORAL | 7258 mg | ||
| Sucrose | SUCROSE | C151H8M554 | ELIXIR / ORAL | 18000 mg | ||
| Sucrose | SUCROSE | C151H8M554 | WAFER / ORAL | 155.2 mg |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 348f1453-cf15-7ab3-749f-ff983025085d | d090426e-7b68-c0f1-3105-bb911e642576 | 2011-06-01 | Warnings | 348f1453-cf15-7ab3-749f-ff983025085d d090426e-7b68-c0f1-3105-bb911e642576 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
