Prostate
- 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 02:03:58
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
PRODUCT NAME & INDICATIONS SECTION
Prostate Formulated for symptoms associated with erectile dysfunction, benign prostatic hypertrophy, prostatitis, dysuria and other prostate related conditions.
DIRECTION SECTION
Directions: ORAL USE ONLY - SHAKE WELL. Adults, take 6 drops orally one to four times daily or as directed by a healthcare professional.
ACTIVE INGREDIENT SECTION
Thyroidinum 15x, Baryta carb. 10x ,Berber. vulg. 10x, Bryonia 10x, Calc. carb. 10x, Cinchona 10x ,Conium 10x, Digitalis 10x, Ferrum picricum 10x, Hydrastis 10x, Iodium 10x, Lycopodium 10x, Nux vom. 10x, Pareira 10x, Pulsatilla 10x, Sabal 10x, Selenium 10x, Staphysag. 10x, Thuja occ. 10x, Trifolium pratense 10x, Echinacea 3x, Hydrastis 3x, Lappa 3x, Solidago 3x.
PURPOSE SECTION
Formulated for symptoms associated with erectile dysfunction, benign prostatic hypertrophy, prostatitis, dysuria and other prostate related conditions.
INACTIVE INGREDIENT SECTION
USP Purified water; USP Gluten-free,non-GMO, organic cane dispensing alcohol 20%.
QUESTIONS? SECTION
www.newtonlabs.net Newton Laboratories, Inc. FDA Est # 1051203 - Conyers, GA30012
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.
OTC - PREGNANCY OR BREAST FEEDING SECTION
Consult a licensed healthcare professional if pregnant, nursing or if symptoms worsen or persist for more than a few days.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
PACKAGE LABEL
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 55714-4464-1 | 2020-01-31 | C162847 | 48780-1 | 9d75b9cf-d811-f424-e053-dadaa90a57ce | Prostate |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-4464-1 | Prostate | 29.57 mL in 1 BOTTLE, GLASS | LIQUID | 29.57 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-4464 | 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, HYDRASTIS, LAPPA, SOLIDAGO) LIQUID [NEWTON LABORATORIES, INC.] | 1 | Legacy NDC, 1 package rows | 20120914_7adf3df7-3f05-20de-5cb9-9b66a7bbe5fa.zip |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Arctium Lappa Root | ACTIVE INGREDIENT | 597E9BI3Z3 | 1 | |
| Barium Carbonate | ACTIVE INGREDIENT | 6P669D8HQ8 | 1 | |
| Berberis Vulgaris Root Bark | ACTIVE INGREDIENT | 1TH8Q20J0U | 1 | |
| Bryonia Alba Root | ACTIVE INGREDIENT | T7J046YI2B | 1 | |
| Chondrodendron Tomentosum Root | ACTIVE INGREDIENT | 395A3P448Z | 1 | |
| Cinchona Officinalis Bark | ACTIVE INGREDIENT | S003A158SB | 1 | |
| Conium Maculatum Flowering Top | ACTIVE INGREDIENT | Q28R5GF371 | 1 | |
| Delphinium Staphisagria Seed | ACTIVE INGREDIENT | 00543AP1JV | 1 | |
| Digitalis | ACTIVE INGREDIENT | F1T8QT9U8B | 1 | |
| Echinacea, Unspecified | ACTIVE INGREDIENT | 4N9P6CC1DX | 1 | |
| Ferric Picrate | ACTIVE INGREDIENT | KZM8ZRY36A | 1 | |
| Goldenseal | ACTIVE INGREDIENT | ZW3Z11D0JV | 1 | |
| Iodine | ACTIVE INGREDIENT | 9679TC07X4 | 1 | |
| Lycopodium Clavatum Spore | ACTIVE INGREDIENT | C88X29Y479 | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE INGREDIENT | 2E32821G6I | 1 | |
| Pulsatilla Vulgaris | ACTIVE INGREDIENT | I76KB35JEV | 1 | |
| Saw Palmetto | ACTIVE INGREDIENT | J7WWH9M8QS | 1 | |
| Selenium | ACTIVE INGREDIENT | H6241UJ22B | 1 | |
| Solidago Virgaurea Flowering Top | ACTIVE INGREDIENT | 5405K23S50 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE INGREDIENT | 269XH13919 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE INGREDIENT | 1NT28V9397 | 1 | |
| Thyroid, Unspecified | ACTIVE INGREDIENT | 0B4FDL9I6P | 1 | |
| Trifolium Pratense Flower | ACTIVE INGREDIENT | 4JS0838828 | 1 | |
| Arctium Lappa Root | ACTIVE MOIETY | 597E9BI3Z3 | 1 | |
| Barium Cation | ACTIVE MOIETY | V645272HLN | 1 | |
| Berberis Vulgaris Root Bark | ACTIVE MOIETY | 1TH8Q20J0U | 1 | |
| Bryonia Alba Root | ACTIVE MOIETY | T7J046YI2B | 1 | |
| Chondrodendron Tomentosum Root | ACTIVE MOIETY | 395A3P448Z | 1 | |
| Cinchona Officinalis Bark | ACTIVE MOIETY | S003A158SB | 1 | |
| Conium Maculatum Flowering Top | ACTIVE MOIETY | Q28R5GF371 | 1 | |
| Delphinium Staphisagria Seed | ACTIVE MOIETY | 00543AP1JV | 1 | |
| Digitalis | ACTIVE MOIETY | F1T8QT9U8B | 1 | |
| Echinacea, Unspecified | ACTIVE MOIETY | 4N9P6CC1DX | 1 | |
| Ferric Cation | ACTIVE MOIETY | 91O4LML611 | 1 | |
| Goldenseal | ACTIVE MOIETY | ZW3Z11D0JV | 1 | |
| Iodine | ACTIVE MOIETY | 9679TC07X4 | 1 | |
| Lycopodium Clavatum Spore | ACTIVE MOIETY | C88X29Y479 | 1 | |
| Oyster Shell Calcium Carbonate, Crude | ACTIVE MOIETY | 2E32821G6I | 1 | |
| Pulsatilla Vulgaris | ACTIVE MOIETY | I76KB35JEV | 1 | |
| Saw Palmetto | ACTIVE MOIETY | J7WWH9M8QS | 1 | |
| Selenium | ACTIVE MOIETY | H6241UJ22B | 1 | |
| Solidago Virgaurea Flowering Top | ACTIVE MOIETY | 5405K23S50 | 1 | |
| Strychnos Nux-vomica Seed | ACTIVE MOIETY | 269XH13919 | 1 | |
| Thuja Occidentalis Leafy Twig | ACTIVE MOIETY | 1NT28V9397 | 1 | |
| Thyroid, Unspecified | ACTIVE MOIETY | 0B4FDL9I6P | 1 | |
| Trifolium Pratense Flower | ACTIVE MOIETY | 4JS0838828 | 1 | |
| Alcohol | INACTIVE INGREDIENT | 3K9958V90M | 1 |
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, Hydrastis, Lappa, Solidago
- 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
- Iodine
- Lycopodium Clavatum Spore
- Strychnos Nux-vomica Seed
- Chondrodendron Tomentosum Root
- Pulsatilla Vulgaris
- Saw Palmetto
- Selenium
- Delphinium Staphisagria Seed
- Thuja Occidentalis Leafy Twig
- Trifolium Pratense Flower
- Echinacea, Unspecified
- Arctium Lappa Root
- Solidago Virgaurea Flowering Top
- Alcohol
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55714-4464 | 55714-4464-1 |
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 |
|---|---|---|---|---|---|---|
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY, METERED / SUBLINGUAL | 29 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / BUCCAL | 679 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAMUSCULAR | 1491 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TRANSDERMAL | 7360 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / SUBCUTANEOUS | 6.1 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | JELLY / VAGINAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / ORAL | 150.68 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAVENOUS | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / NASAL | 10 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SWAB / TOPICAL | 2250 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / TOPICAL | 9971 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / RECTAL | 0.35 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / RESPIRATORY (INHALATION) | 26664 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / ORAL | 210 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TOPICAL | 541 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION, CONCENTRATE / INTRAVENOUS | 4000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | POWDER, FOR SOLUTION / TOPICAL | 40 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SHAMPOO / TOPICAL | 714 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | ELIXIR / ORAL | 13675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TOPICAL | 2445 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE, EXTENDED RELEASE / ORAL | 8 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / RESPIRATORY (INHALATION) | 5 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | PASTE / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVENOUS | 99 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVASCULAR | 100 %v/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / SUBCUTANEOUS | 149 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / INTRAMUSCULAR | 400 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / DENTAL | 12.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / DENTAL | 1.8 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | LIQUID / ORAL | 3563 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TRANSDERMAL | 90 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, EMULSION / INTRAVENOUS | 520 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | LOTION / TOPICAL | 25 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / INTRAVESICAL | 7892 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL / RECTAL | 898 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | MOUTHWASH / BUCCAL | 200 mg/1ml | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / RESPIRATORY (INHALATION) | 0.08 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / OPHTHALMIC | 0.5 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / NASAL | 20 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, METERED / NASAL | 70 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / SUBLINGUAL | 397 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | CONCENTRATE / ORAL | 198 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAMUSCULAR | 1000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, SPRAY / RESPIRATORY (INHALATION) | 35.75 %w/w | ||
| Alcohol | ALCOHOL | 3K9958V90M | SPRAY / TOPICAL | 3633 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | TABLET, DELAYED RELEASE / ORAL | NA | ||
| Alcohol | ALCOHOL | 3K9958V90M | CAPSULE / ORAL | 882 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL / TOPICAL | 561 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / ORAL | 6624 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SYRUP / ORAL | 21000 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SOLUTION / TRANSDERMAL | 49.37 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION, SOLUTION / INTRAVENOUS | 6405 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | GEL, METERED / TRANSDERMAL | 3675 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | AEROSOL, FOAM / TOPICAL | 4504 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | SUSPENSION / ORAL | 681 mg | ||
| Alcohol | ALCOHOL | 3K9958V90M | INJECTION / INTRAVENOUS | 92 %w/v | ||
| Alcohol | ALCOHOL | 3K9958V90M | DROPS / NASAL | 10 mg/1ml |
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 |
|---|---|---|---|---|---|---|
| c2cbd06b-b85a-221f-7ddb-ba542dc4fb5e | 7adf3df7-3f05-20de-5cb9-9b66a7bbe5fa | 2011-06-01 | Warnings | c2cbd06b-b85a-221f-7ddb-ba542dc4fb5e 7adf3df7-3f05-20de-5cb9-9b66a7bbe5fa |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
