FDA.reportPublic FDA data

FNGSODE

Manufacturer
Synergy Formulas, Inc. | Apotheca Company
Effective date
2013-08-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:52

Label at a glance#

ProductFNGSODE
Active ingredientCEANOTHUS AMERICANUS LEAF, MARSDENIA CONDURANGO BARK, ECHINACEA, UNSPECIFIED, GOLDENSEAL, LIGUSTICUM PORTERI ROOT, LOMATIUM DISSECTUM ROOT, NASTURTIUM OFFICINALE, TABEBUIA IMPETIGINOSA BARK, ASTRAGALUS PROPINQUUS ROOT, PROPOLIS WAX, SODIUM BORATE, BOS TAURUS SPLEEN, BOS TAURUS THYMUS, BOS TAURUS ADRENAL GLAND, PORK KIDNEY, PHOSPHORIC ACID, PHYTOLACCA AMERICANA ROOT, SEPIA OFFICINALIS JUICE, CANDIDA ALBICANS
Label structure9 sections

Dosage and administration

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Ceanothus Americanus 1X, Condurango 3X, Echinacea 3X, Hydrastis Canadensis 3X, Ligusticum Porteri 3X, Lomatium Dissectum 3X, Nasturtium Aquaticum 3X, Tabebuia Impetiginosa 3X, 6X, Astragalus Membranaceus 6X, Propolis 6X, Borax 6X, 12X, Spleen (Bovine) 8X, Thymus (Bovine) 8X, Glandula Suprarenalis Bovine 8X, 12X, 60X, Kidney (Suis) 8X, 12X, 60X, Phosphoricum Acidum 12X, Phytolacca Decandra 12X, Sepia 12X, Candida Albicans 12X, 30X, 60X, 100X.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of allergic rhinitis, bloating, heartburn, and intolerance of dried fruits.

WARNINGS:

WARNINGS SECTION

​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

​If pregnant or breast-feeding,​ as a health professional before use.

Do not use if tamper evident seal is broken or missing.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

10 drops orally, 3 times a day. Consult a physician for use in children under 12 years of age.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Demineralized Water, 25% Ethanol

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

​Keep out of reach of children.​ In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of allergice rhinitis, bloating, heartburn, and intolerance of dried fruits.

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by:

SYNERGY FORMULAS, INC.

251 West Road

Campobello, SC 29322

PACKAGE DISPLAY LABEL:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Synergy Formulas

FNGSODE

HOMEOPATHIC

2 FL OZ (60 mL)

image descriptionimage description

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43772-0016-12020-01-31C16284748780-19d75b9d0-eec3-f424-e053-dadaa90a57ceDRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43772-0016-1FNGSODE60 mL in 1 BOTTLE, DROPPERLIQUID601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43772-0016FNGSODE (CEANOTHUS AMERICANUS, CONDURANGO, ECHINACEA, HYDRASTIS CANADENSIS, LIGUSTICUM PORTERI, LOMATIUM DISSECTUM, NASTURTIUM AQUATICUM) LIQUID [SYNERGY FORMULAS, INC.]1Legacy NDC, 1 package rows20130820_dac884d3-33f5-4248-9f8e-3eb8566a5452.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASTRAGALUS PROPINQUUS ROOTACTIVE INGREDIENT922OP8YUPF1
BOS TAURUS ADRENAL GLANDACTIVE INGREDIENTM2776SWB291
BOS TAURUS SPLEENACTIVE INGREDIENT190Q9MB3U31
BOS TAURUS THYMUSACTIVE INGREDIENT8XEJ88V2T81
CANDIDA ALBICANSACTIVE INGREDIENT4D7G21HDBC1
CEANOTHUS AMERICANUS LEAFACTIVE INGREDIENT25B1Y14T8N1
ECHINACEA, UNSPECIFIEDACTIVE INGREDIENT4N9P6CC1DX1
GOLDENSEALACTIVE INGREDIENTZW3Z11D0JV1
LIGUSTICUM PORTERI ROOTACTIVE INGREDIENT81FGO4H42J1
LOMATIUM DISSECTUM ROOTACTIVE INGREDIENT5329928G5N1
MARSDENIA CONDURANGO BARKACTIVE INGREDIENTR23QIR6YBA1
NASTURTIUM OFFICINALEACTIVE INGREDIENTYH89GMV6761
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
PHYTOLACCA AMERICANA ROOTACTIVE INGREDIENT11E6VI8VEG1
PORK KIDNEYACTIVE INGREDIENTX7BCI5P86H1
PROPOLIS WAXACTIVE INGREDIENT6Y8XYV2NOF1
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C21
SODIUM BORATEACTIVE INGREDIENT91MBZ8H3QO1
TABEBUIA IMPETIGINOSA BARKACTIVE INGREDIENT6GLA1946WX1
ASTRAGALUS PROPINQUUS ROOTACTIVE MOIETY922OP8YUPF1
BORATE IONACTIVE MOIETY44OAE30D221
BOS TAURUS ADRENAL GLANDACTIVE MOIETYM2776SWB291
BOS TAURUS SPLEENACTIVE MOIETY190Q9MB3U31
BOS TAURUS THYMUSACTIVE MOIETY8XEJ88V2T81
CANDIDA ALBICANSACTIVE MOIETY4D7G21HDBC1
CEANOTHUS AMERICANUS LEAFACTIVE MOIETY25B1Y14T8N1
ECHINACEA, UNSPECIFIEDACTIVE MOIETY4N9P6CC1DX1
GOLDENSEALACTIVE MOIETYZW3Z11D0JV1
LIGUSTICUM PORTERI ROOTACTIVE MOIETY81FGO4H42J1
LOMATIUM DISSECTUM ROOTACTIVE MOIETY5329928G5N1
MARSDENIA CONDURANGO BARKACTIVE MOIETYR23QIR6YBA1
NASTURTIUM AQUATICUMACTIVE MOIETYYH89GMV6761
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
PHYTOLACCA AMERICANA ROOTACTIVE MOIETY11E6VI8VEG1
PORK KIDNEYACTIVE MOIETYX7BCI5P86H1
PROPOLIS WAXACTIVE MOIETY6Y8XYV2NOF1
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C21
TABEBUIA IMPETIGINOSA BARKACTIVE MOIETY6GLA1946WX1
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43772-001643772-0016-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
MARSDENIA CONDURANGO BARKR23QIR6YBAACTIB
ECHINACEA, UNSPECIFIED4N9P6CC1DXACTIB
GOLDENSEALZW3Z11D0JVACTIB
LIGUSTICUM PORTERI ROOT81FGO4H42JACTIB
LOMATIUM DISSECTUM ROOT5329928G5NACTIB
NASTURTIUM OFFICINALEYH89GMV676ACTIB
TABEBUIA IMPETIGINOSA BARK6GLA1946WXACTIB
ASTRAGALUS PROPINQUUS ROOT922OP8YUPFACTIB
PROPOLIS WAX6Y8XYV2NOFACTIB
SODIUM BORATE91MBZ8H3QOACTIB
BOS TAURUS SPLEEN190Q9MB3U3ACTIB
BOS TAURUS THYMUS8XEJ88V2T8ACTIB
BOS TAURUS ADRENAL GLANDM2776SWB29ACTIB
PORK KIDNEYX7BCI5P86HACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHYTOLACCA AMERICANA ROOT11E6VI8VEGACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
CANDIDA ALBICANS4D7G21HDBCACTIB
WATER059QF0KO0RIACT
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, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 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
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact 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
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/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
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact 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
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact 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
3d08a10b-272c-4808-b0bf-8d153eefd899dac884d3-33f5-4248-9f8e-3eb8566a54522013-08-12WarningsExact identifier
spl id: 3d08a10b-272c-4808-b0bf-8d153eefd899
spl set id: dac884d3-33f5-4248-9f8e-3eb8566a5452

Reported adverse events (FAERS/openFDA)#

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