Para-Si

Product NDC
55714-2593
11-digit product format
557142593
Labeler code
55714
Product ID
55714-2593_27d41614-3a78-e814-e063-6394a90a94bc
Type
HUMAN OTC DRUG
Nonproprietary name
Juglans reg, Abrotanum, Aesculus hipp, Allium sat, Arsenicum alb, Artemisia, Baptisia, Cina, Cuprum met, Filix mas, Granatum, Ipecac, Lachesis, Lycopodium, Merc viv, Naphthalinum, Nat mur, Nux vom, Pulsatilla, Ratanhia, Ruta, Sabadilla, Santoninum, Silicea, Spigelia anth, Terebinthina, Teucrium mar, Thymolum, Zingiber
Dosage form
LIQUID
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]/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; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
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 table
IngredientStrength
ANEMONE PULSATILLA15 [hp_X]/mL
ARSENIC TRIOXIDE15 [hp_X]/mL
ARTEMISIA ABROTANUM FLOWERING TOP15 [hp_X]/mL
ARTEMISIA CINA PRE-FLOWERING TOP15 [hp_X]/mL
ARTEMISIA VULGARIS ROOT15 [hp_X]/mL
BAPTISIA TINCTORIA ROOT15 [hp_X]/mL
COPPER15 [hp_X]/mL
DRYOPTERIS FILIX-MAS ROOT15 [hp_X]/mL
GARLIC15 [hp_X]/mL
GINGER15 [hp_X]/mL
HORSE CHESTNUT15 [hp_X]/mL
IPECAC15 [hp_X]/mL
JUGLANS REGIA LEAF6 [hp_X]/mL
KRAMERIA LAPPACEA ROOT15 [hp_X]/mL
LACHESIS MUTA VENOM15 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE15 [hp_X]/mL
MERCURY15 [hp_X]/mL
NAPHTHALENE15 [hp_X]/mL
PUNICA GRANATUM ROOT BARK15 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP15 [hp_X]/mL
SANTONIN15 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED15 [hp_X]/mL
SILICON DIOXIDE15 [hp_X]/mL
SODIUM CHLORIDE15 [hp_X]/mL
SPIGELIA ANTHELMIA15 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED15 [hp_X]/mL
TEUCRIUM MARUM15 [hp_X]/mL
THYMOL15 [hp_X]/mL
TURPENTINE OIL15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiI76KB35JEV, S7V92P67HO, QG07G580U0, 28M1820ACT, 32MP823R8S, 5EF0HWI5WU, 789U1901C5, C0ZK0RRF5X, V1V998DC17, C5529G5JPQ, 3C18L6RJAZ, 62I3C8233L, 85HKB87105, P29ZH1A35Z, VSW71SS07I, C88X29Y479, FXS1BY2PGL, 2166IN72UN, CLV24I3T1D, N94C2U587S

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-2593-1Para-Si30 mL in 1 BOTTLE, GLASSLIQUID302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-2593PARA-SI (JUGLANS REG, ABROTANUM, AESCULUS HIPP, ALLIUM SAT, ARSENICUM ALB, ARTEMISIA, BAPTISIA, CINA, CUPRUM MET, FILIX MAS, GRANATUM, IPECAC, LACHESIS, LYCOPODIUM, MERC VIV, NAPHTHALINUM, NAT MUR, NUX VOM, PULSATILLA, RATANHIA, RUTA, SABADILLA, SANTONINUM, SILICEA, SPIGELIA ANTH, TEREBINTHINA, TEUCRIUM MAR, THYMOLUM, ZINGIBER) LIQUID [NEWTON LABORATORIES, INC.]2Current NDC, 1 package rows20241127_27d41602-9dcb-eaa8-e063-6394a90a7cfa.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-2593-15571425930130 mL in 1 BOTTLE, GLASS (55714-2593-1) 30 ml2024-11-26NoNoHistorical