Prostatone
- Product NDC
- 43857-0492
- 11-digit product format
- 438570492
- Labeler code
- 43857
- Product ID
- 43857-0492_47cfa6d2-2a00-4198-a437-bf0f4fc39d52
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Echinacea (Angustifolia), Sabal Serrulata, Sarsaparilla (Smilax Regelii), Solidago Virgaurea, Zincum Sulphuricum, Phytolacca Decandra, Hydrastis Canadensis, Orchitinum (Suis), Prostate (Suis), Clematis Erecta, Phosphoricum Acidum, Pulsatilla (Vulgaris)
- Dosage form
- LIQUID
- Route
- ORAL
- Labeler
- BioActive Nutritional, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2018-08-29
- Substance
- ECHINACEA ANGUSTIFOLIA WHOLE; SAW PALMETTO; SMILAX ORNATA ROOT; SOLIDAGO VIRGAUREA FLOWERING TOP; ZINC SULFATE HEPTAHYDRATE; PHYTOLACCA AMERICANA ROOT; GOLDENSEAL; SUS SCROFA TESTICLE; SUS SCROFA PROSTATE; CLEMATIS RECTA FLOWERING TOP; PHOSPHORIC ACID; PULSATILLA VULGARIS WHOLE
- Active strength
- 3; 3; 3; 3; 3; 4; 5; 8; 8; 12; 12; 12 [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
- Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
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
- Prostatone
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| ECHINACEA ANGUSTIFOLIA WHOLE | 3 [hp_X]/mL |
| SAW PALMETTO | 3 [hp_X]/mL |
| SMILAX ORNATA ROOT | 3 [hp_X]/mL |
| SOLIDAGO VIRGAUREA FLOWERING TOP | 3 [hp_X]/mL |
| ZINC SULFATE HEPTAHYDRATE | 3 [hp_X]/mL |
| PHYTOLACCA AMERICANA ROOT | 4 [hp_X]/mL |
| GOLDENSEAL | 5 [hp_X]/mL |
| SUS SCROFA TESTICLE | 8 [hp_X]/mL |
| SUS SCROFA PROSTATE | 8 [hp_X]/mL |
| CLEMATIS RECTA FLOWERING TOP | 12 [hp_X]/mL |
| PHOSPHORIC ACID | 12 [hp_X]/mL |
| PULSATILLA VULGARIS WHOLE | 12 [hp_X]/mL |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 43857-0492-1 | Prostatone | 30 mL in 1 BOTTLE, DROPPER | LIQUID | 30 | | 2 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 43857-0492 | PROSTATONE (ECHINACEA (ANGUSTIFOLIA), SABAL SERRULATA, SARSAPARILLA (SMILAX REGELII), SOLIDAGO VIRGAUREA, ZINCUM SULPHURICUM, PHYTOLACCA DECANDRA, HYDRASTIS CANADENSIS, ORCHITINUM (SUIS), PROSTATE (SUIS), CLEMATIS ERECTA, PHOSPHORICUM ACIDUM, PULSATILLA (VULGARIS)) LIQUID [BIOACTIVE NUTRITIONAL, INC.] | 2 | Current NDC, Legacy NDC, 1 package rows | 20250403_5f3f74e3-3772-4642-82bd-45c77a21a5c1.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 43857-0492-1 | 43857049201 | 30 mL in 1 BOTTLE, DROPPER (43857-0492-1) | 30 ml | 2018-08-29 | 0000-00-00 | No | No | Current |