Para-Si
- Product NDC
- 55714-2594
- 11-digit product format
- 557142594
- Labeler code
- 55714
- Product ID
- 55714-2594_27d4f0eb-04b6-cf82-e063-6394a90a897e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Juglans reg, Abrotanum, Aesculus hipp, Allium sat, Arsenicum alb, Artemisia, Baptisia, Cina, Cuprum met, Filix mas, Granatum, Ipecac, Lacheis, Lycopodium, Merc viv, Naphthalinum, Nat mur, Nux vom, Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth, Terebinthina, Teucrium mar, Thymolum, Zingiber
- Dosage form
- PELLET
- Route
- ORAL
- Labeler
- Newton Laboratories, Inc.
- Marketing category
- UNAPPROVED HOMEOPATHIC
- Marketing start
- 2024-11-26
- Substance
- ANEMONE PULSATILLA; ARSENIC TRIOXIDE; ARTEMISIA ABROTANUM FLOWERING TOP; ARTEMISIA CINA PRE-FLOWERING TOP; ARTEMISIA VULGARIS ROOT; BAPTISIA TINCTORIA ROOT; COPPER; DRYOPTERIS FILIX-MAS ROOT; GARLIC; GINGER; HORSE CHESTNUT; IPECAC; JUGLANS REGIA LEAF; KRAMERIA LAPPACEA ROOT; LACHESIS MUTA VENOM; LYCOPODIUM CLAVATUM SPORE; MERCURY; NAPHTHALENE; PUNICA GRANATUM ROOT BARK; RUTA GRAVEOLENS FLOWERING TOP; SANTONIN; SCHOENOCAULON OFFICINALE SEED; SILICON DIOXIDE; SODIUM CHLORIDE; SPIGELIA ANTHELMIA; STRYCHNOS NUX-VOMICA SEED; TEUCRIUM MARUM; THYMOL; TURPENTINE OIL
- Active strength
- 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 6; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15; 15 [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g; [hp_X]/g
- Pharmacologic classes
- Allergens [CS], Allergens [CS], Allergens [CS], 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], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased Large Intestinal Motility [PE], Inhibit Ovum Fertilization [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Osmotic Activity [MoA], Osmotic Laxative [EPC], Plant Proteins [CS], Plant Proteins [CS], Plant Proteins [CS], Seed Storage Proteins [CS]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Para-Si
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| JUGLANS REGIA LEAF | 15 [hp_X]/g |
| SPIGELIA ANTHELMIA | 15 [hp_X]/g |
| THYMOL | 15 [hp_X]/g |
| GARLIC | 15 [hp_X]/g |
| ARSENIC TRIOXIDE | 15 [hp_X]/g |
| BAPTISIA TINCTORIA ROOT | 15 [hp_X]/g |
| ARTEMISIA CINA PRE-FLOWERING TOP | 15 [hp_X]/g |
| COPPER | 15 [hp_X]/g |
| DRYOPTERIS FILIX-MAS ROOT | 15 [hp_X]/g |
| PUNICA GRANATUM ROOT BARK | 15 [hp_X]/g |
| MERCURY | 15 [hp_X]/g |
| IPECAC | 15 [hp_X]/g |
| LACHESIS MUTA VENOM | 6 [hp_X]/g |
| LYCOPODIUM CLAVATUM SPORE | 15 [hp_X]/g |
| ARTEMISIA ABROTANUM FLOWERING TOP | 15 [hp_X]/g |
| ANEMONE PULSATILLA | 15 [hp_X]/g |
| NAPHTHALENE | 15 [hp_X]/g |
| SODIUM CHLORIDE | 15 [hp_X]/g |
| STRYCHNOS NUX-VOMICA SEED | 15 [hp_X]/g |
| KRAMERIA LAPPACEA ROOT | 15 [hp_X]/g |
| RUTA GRAVEOLENS FLOWERING TOP | 15 [hp_X]/g |
| SCHOENOCAULON OFFICINALE SEED | 15 [hp_X]/g |
| SANTONIN | 15 [hp_X]/g |
| HORSE CHESTNUT | 15 [hp_X]/g |
| SILICON DIOXIDE | 15 [hp_X]/g |
| TURPENTINE OIL | 15 [hp_X]/g |
| GINGER | 15 [hp_X]/g |
| TEUCRIUM MARUM | 15 [hp_X]/g |
| ARTEMISIA VULGARIS ROOT | 15 [hp_X]/g |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 85HKB87105 | Internal UNII lookup |
| WYT05213GE | Internal UNII lookup |
| 3J50XA376E | Internal UNII lookup |
| V1V998DC17 | Internal UNII lookup |
| S7V92P67HO | Internal UNII lookup |
| 5EF0HWI5WU | Internal UNII lookup |
| 28M1820ACT | Internal UNII lookup |
| 789U1901C5 | Internal UNII lookup |
| C0ZK0RRF5X | Internal UNII lookup |
| CLV24I3T1D | Internal UNII lookup |
| FXS1BY2PGL | Internal UNII lookup |
| 62I3C8233L | Internal UNII lookup |
| VSW71SS07I | Internal UNII lookup |
| C88X29Y479 | Internal UNII lookup |
| QG07G580U0 | Internal UNII lookup |
| I76KB35JEV | Internal UNII lookup |
| 2166IN72UN | Internal UNII lookup |
| 451W47IQ8X | Internal UNII lookup |
| 269XH13919 | Internal UNII lookup |
| P29ZH1A35Z | Internal UNII lookup |
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 55714-2594-1 | Para-Si | 28 g in 1 BOTTLE, GLASS | PELLET | 28 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 55714-2594 | PARA-SI (JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER) PELLET [NEWTON LABORATORIES, INC.] | 1 | Current NDC, 1 package rows | 20241127_27d4ddaf-9c07-a7fc-e063-6394a90adc0b.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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Para-Si | JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHEIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER | Newton Laboratories, Inc. | 27d4ddaf-9c07-a7fc-e063-6394a90adc0b | 2024-11-26 | Warnings | 55714-2594 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|
| 55714-2594-1 | 55714259401 | 28 g in 1 BOTTLE, GLASS (55714-2594-1) | 28 g | 2024-11-26 | No | No | Current |