Prostate
- Manufacturer
- Newton Laboratories, Inc.
- Effective date
- 2025-12-03
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 02:35:38
Label at a glance#
ProductProstate
Active ingredientIODINE, 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
Label structure10 sections
Contacts and useful links#
Label contents#
Full prescribing information#
INDICATIONS & USAGE SECTION
Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination.
DOSAGE & ADMINISTRATION SECTION
Directions: Adults, take 6 drops by mouth one to four times daily or as directed by a health professional.
OTC - ACTIVE INGREDIENT SECTION
Equal parts of Echinacea 6x, Hydrastis canadensis 6x, Lappa major 6x, Solidago virgaurea 6x, Baryta carbonica 15x, Berberis vulgaris 15x, Bryonia 15x, Calcarea carbonica 15x, Cinchona officinalis 15x, Conium maculatum 15x, Digitalis purpurea 15x, Ferrum picricum 15x, Hydrastis canadensis 15x, Iodium 15x, Lycopodium clavatum 15x, Nux vomica 15x, Pareira brava 15x, Pulsatilla 15x, Sabal serrulata 15x, Selenium metallicum 15x, Staphysagria 15x, Thuja occidentalis 15x, Thyroidinum 15x, Trifolium pratense 15x.
OTC - PURPOSE SECTION
Formulated for associated symptoms such as discomfort, or frequent, incomplete or difficult urination.
INACTIVE INGREDIENT SECTION
USP Purified Water; USP Gluten-free, non-GMO, organic cane alcohol 20%.
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
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| QR code link | QR Code |  www.newtonlabs.net/PRO-Prostate/productinfo/R033/ | R033-L01.jpg |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4758-1 | Prostate | 30 mL in 1 BOTTLE, GLASS | LIQUID | 30 | 3 |
Products#
Every source-derived product name is available through these pages.
- Prostate
- 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
- WATER
- IODINE
- ALCOHOL
- THYROID, UNSPECIFIED
- BARIUM CARBONATE
- BARIUM CATION
- BERBERIS VULGARIS ROOT BARK
- BRYONIA ALBA ROOT
- OYSTER SHELL CALCIUM CARBONATE, CRUDE
- CINCHONA OFFICINALIS BARK
- CONIUM MACULATUM FLOWERING TOP
- DIGITALIS
- FERRIC PICRATE
- FERRIC CATION
- 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
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4758 | 55714-4758-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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 |
|---|---|---|---|---|---|---|
| Prostate | 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 | Newton Laboratories, Inc. | 9986d25e-f4c2-51d3-e053-2a95a90a8548 | 2025-12-03 | Warnings | 55714-4758-1 55714-4758 55714475801 45144abc-f36c-c1c1-e063-6394a90ac0b8 9986d25e-f4c2-51d3-e053-2a95a90a8548 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.