Prostate

Product NDC
55714-4758
11-digit product format
557144758
Labeler code
55714
Product ID
55714-4758_45144abc-f36c-c1c1-e063-6394a90ac0b8
Type
HUMAN OTC DRUG
Nonproprietary name
Thyroidinum, Baryta carb., Berber. vulg., Bryonia, Calc. carb., Cinchona, Conium, Digitalis, Ferrum picricum, Hydrastis, Iodium, Lycopodium, Nux vom., Pareira, Pulsatilla, Sabal, Selenium, Staphysag., Thuja occ.,Trifolium pratense, Echinacea, Lappa, Solidago
Dosage form
LIQUID
Route
ORAL
Labeler
Newton Laboratories, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2019-09-02
Substance
IODINE; THYROID, UNSPECIFIED; BARIUM CARBONATE; BERBERIS VULGARIS ROOT BARK; BRYONIA ALBA ROOT; OYSTER SHELL CALCIUM CARBONATE, CRUDE; CINCHONA OFFICINALIS BARK; CONIUM MACULATUM FLOWERING TOP; DIGITALIS; FERRIC PICRATE; GOLDENSEAL; LYCOPODIUM CLAVATUM SPORE; STRYCHNOS NUX-VOMICA SEED; CHONDRODENDRON TOMENTOSUM ROOT; ANEMONE PULSATILLA; SAW PALMETTO; SELENIUM; DELPHINIUM STAPHISAGRIA SEED; THUJA OCCIDENTALIS LEAFY TWIG; TRIFOLIUM PRATENSE FLOWER; ECHINACEA, UNSPECIFIED; ARCTIUM LAPPA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP
Active strength
15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 6; 6 [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], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Iron [CS], Non-Standardized Plant Allergenic Extract [EPC], Parenteral Iron Replacement [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Plant Proteins [CS], Seed Storage Proteins [CS]
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 packagepackage55714-4758-1ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage55714-4758-10efc9e666f02…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
Prostate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
IODINE15 [hp_X]/mL
THYROID, UNSPECIFIED15 [hp_X]/mL
BARIUM CARBONATE15 [hp_X]/mL
BERBERIS VULGARIS ROOT BARK15 [hp_X]/mL
BRYONIA ALBA ROOT15 [hp_X]/mL
OYSTER SHELL CALCIUM CARBONATE, CRUDE15 [hp_X]/mL
CINCHONA OFFICINALIS BARK15 [hp_X]/mL
CONIUM MACULATUM FLOWERING TOP15 [hp_X]/mL
DIGITALIS15 [hp_X]/mL
FERRIC PICRATE15 [hp_X]/mL
GOLDENSEAL15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
CHONDRODENDRON TOMENTOSUM ROOT15 [hp_X]/mL
ANEMONE PULSATILLA15 [hp_X]/mL
SAW PALMETTO15 [hp_X]/mL
SELENIUM15 [hp_X]/mL
DELPHINIUM STAPHISAGRIA SEED15 [hp_X]/mL
THUJA OCCIDENTALIS LEAFY TWIG15 [hp_X]/mL
TRIFOLIUM PRATENSE FLOWER15 [hp_X]/mL
ECHINACEA, UNSPECIFIED6 [hp_X]/mL
ARCTIUM LAPPA ROOT6 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP6 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 23 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9679TC07X4Internal UNII lookup
0B4FDL9I6PInternal UNII lookup
6P669D8HQ8Internal UNII lookup
1TH8Q20J0UInternal UNII lookup
T7J046YI2BInternal UNII lookup
2E32821G6IInternal UNII lookup
S003A158SBInternal UNII lookup
Q28R5GF371Internal UNII lookup
F1T8QT9U8BInternal UNII lookup
KZM8ZRY36AInternal UNII lookup
ZW3Z11D0JVInternal UNII lookup
C88X29Y479Internal UNII lookup
269XH13919Internal UNII lookup
395A3P448ZInternal UNII lookup
I76KB35JEVInternal UNII lookup
J7WWH9M8QSInternal UNII lookup
H6241UJ22BInternal UNII lookup
00543AP1JVInternal UNII lookup
1NT28V9397Internal UNII lookup
4JS0838828Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
9986d25e-f4c2-51d3-e053-2a95a90a8548Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
5f30b278-5791-4113-8781-878a9221ef8aProduct name220230125
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
04cdd491-d111-4bc2-9549-75c575e1bd4bProduct name120200714
8390fb8b-6c75-416c-a9a1-70e8ed493b73Product name120200611
96a528e9-23e2-495f-81b9-ae87df2f7552Product name120191120
2a70c781-a755-4d76-b20a-a958acfbdcdcProduct name220190619
304592ef-4a8a-4c22-8e8c-af73aa3d60e5Product name120180703
ac0821a1-ce75-4ea7-880a-59eecaecdf22Product name120180703
db5dc4f9-b907-46f6-8fb7-babcf04bbe5cProduct name120180619
41e9d6cf-3ed7-4c44-a57e-0685058d0896Product name120170824
5e652c92-68fd-426b-b0e7-5fc64e0b9f99Product name120170309
3df56c93-5837-4523-aac2-4b1ec48b9676Product name220160719
a883b7cc-d320-41d7-92ae-c873457ae641Product name120151116
ddc0c11a-bba8-408f-b3c7-c4828b4bcc8cProduct name120150421
bb23e78e-9e64-4037-a1c1-0e1d8762700eProduct name120150325
ef06c001-572c-d95e-42f6-ee83da75673aProduct name120140508
fd21f957-6863-d07b-5a35-250186878716Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4758-1Prostate30 mL in 1 BOTTLE, GLASSLIQUID303

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4758PROSTATE (THYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC.,TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGO) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, Legacy NDC, 1 package rows20201208_9986d25e-f4c2-51d3-e053-2a95a90a8548.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
ProstateTHYROIDINUM, BARYTA CARB., BERBER. VULG., BRYONIA, CALC. CARB., CINCHONA, CONIUM, DIGITALIS, FERRUM PICRICUM, HYDRASTIS, IODIUM, LYCOPODIUM, NUX VOM., PAREIRA, PULSATILLA, SABAL, SELENIUM, STAPHYSAG., THUJA OCC.,TRIFOLIUM PRATENSE, ECHINACEA, LAPPA, SOLIDAGONewton Laboratories, Inc.9986d25e-f4c2-51d3-e053-2a95a90a85482025-12-03WarningsExact identifier
ndc (product): 55714-4758

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55714-4758-15571447580130 mL in 1 BOTTLE, GLASS (55714-4758-1) 30 ml2019-09-020000-00-00NoNoCurrent