FDA.reportPublic FDA data

Fungal

Product NDC
55714-4788
11-digit product format
557144788
Labeler code
55714
Product ID
55714-4788_b592c526-4f77-c676-e053-2995a90ae63b
Type
HUMAN OTC DRUG
Nonproprietary name
Candida albicans, Sanicula, Tellurium metallicum, Torula cerevisiae, Antimon. crud., Arsenicum alb., Baryta carb., Bryonia, Calc. carb., Carbo veg., Cuprum met., Dulcamara, Graphites, Kali carb., Lachesis, Lycopodium, Mezereum, Nitricum ac., Phosphorus, Phytolacca, Sepia, Silicea, Sulphur, Sulphuricum ac., Zinc. met., Apis mel., Thuja occ.
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
SILICON DIOXIDE; SULFUR; SULFURIC ACID; ZINC; APIS MELLIFERA; THUJA OCCIDENTALIS LEAFY TWIG; CANDIDA ALBICANS; SANICULA EUROPAEA LEAF; TELLURIUM; SACCHAROMYCES CEREVISIAE; ANTIMONY TRISULFIDE; ARSENIC TRIOXIDE; BARIUM CARBONATE; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; ACTIVATED CHARCOAL; COPPER; SOLANUM DULCAMARA TOP; GRAPHITE; POTASSIUM CARBONATE; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; DAPHNE MEZEREUM BARK; NITRIC ACID; PHOSPHORUS; PHYTOLACCA AMERICANA ROOT; SEPIA OFFICINALIS JUICE
Active strength
15; 15; 15; 15; 6; 6; 15; 16; 16; 16; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Bee Venoms [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Copper [CS], Copper-containing Intrauterine Device [EPC], Decreased Embryonic Implantation [PE], Decreased Sperm Motility [PE], Dietary Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Inhibit Ovum Fertilization [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Standardized Insect Venom Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 4 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage55714-4788-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-4788-10efc9e666f02…f202fb6c5f17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Fungal
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
SILICON DIOXIDE15 [hp_X]/mL
SULFUR15 [hp_X]/mL
SULFURIC ACID15 [hp_X]/mL
ZINC15 [hp_X]/mL
APIS MELLIFERA6 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG6 [hp_X]/mL
CANDIDA ALBICANS15 [hp_X]/mL
SANICULA EUROPAEA LEAF16 [hp_X]/mL
TELLURIUM16 [hp_X]/mL
SACCHAROMYCES CEREVISIAE16 [hp_X]/mL
ANTIMONY TRISULFIDE15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
BARIUM CARBONATE15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]/mL
ACTIVATED CHARCOAL15 [hp_X]/mL
COPPER15 [hp_X]/mL
SOLANUM DULCAMARA TOP15 [hp_X]/mL
GRAPHITE15 [hp_X]/mL
POTASSIUM CARBONATE15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
NITRIC ACID15 [hp_X]/mL
PHOSPHORUS15 [hp_X]/mL
PHYTOLACCA AMERICANA ROOT15 [hp_X]/mL
SEPIA OFFICINALIS JUICE15 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 27 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
ETJ7Z6XBU4Internal UNII lookup
70FD1KFU70Internal UNII lookup
O40UQP6WCFInternal UNII lookup
J41CSQ7QDSInternal UNII lookup
7S82P3R43ZInternal UNII lookup
1NT28V9397Internal UNII lookup
4D7G21HDBCInternal UNII lookup
JYZ6110L9IInternal UNII lookup
NQA0O090ZJInternal UNII lookup
978D8U419HInternal UNII lookup
F79059A38UInternal UNII lookup
S7V92P67HOInternal UNII lookup
6P669D8HQ8Internal UNII lookup
T7J046YI2BInternal UNII lookup
2E32821G6IInternal UNII lookup
2P3VWU3H10Internal UNII lookup
789U1901C5Internal UNII lookup
KPS1B1162NInternal UNII lookup
4QQN74LH4OInternal UNII lookup
BQN1B9B9HAInternal UNII lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99487f4a-76f6-407b-e053-2a95a90acfd4Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c599c4a0-705d-4ebb-ab1f-977af038f96aProduct name120251124
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4788-1Fungal30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4788FUNGAL (CANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201204_99487f4a-76f6-407b-e053-2a95a90acfd4.zip

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
FungalCANDIDA ALBICANS, SANICULA, TELLURIUM METALLICUM, TORULA CEREVISIAE, ANTIMON. CRUD., ARSENICUM ALB., BARYTA CARB., BRYONIA, CALC. CARB., CARBO VEG., CUPRUM MET., DULCAMARA, GRAPHITES, KALI CARB., LACHESIS, LYCOPODIUM, MEZEREUM, NITRICUM AC., PHOSPHORUS, PHYTOLACCA, SEPIA, SILICEA, SULPHUR, SULPHURICUM AC., ZINC. MET., APIS MEL., THUJA OCC.Newton Laboratories, Inc.99487f4a-76f6-407b-e053-2a95a90acfd42020-12-03WarningsExact identifier
ndc (product): 55714-4788

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4788-15571447880130 mL in 1 BOTTLE, GLASS (55714-4788-1) 30 ml2019-09-020000-00-00NoNoCurrent