Para-Si

Product NDC
55714-4859
11-digit product format
557144859
Labeler code
55714
Product ID
55714-4859_27d587ec-b67e-ea05-e063-6394a90a9aac
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
20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 11; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20; 20 [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], Inhibit Ovum Fertilization [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], 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 PULSATILLA20 [hp_X]/mL
ARSENIC TRIOXIDE20 [hp_X]/mL
ARTEMISIA ABROTANUM FLOWERING TOP20 [hp_X]/mL
ARTEMISIA CINA PRE-FLOWERING TOP20 [hp_X]/mL
ARTEMISIA VULGARIS ROOT20 [hp_X]/mL
BAPTISIA TINCTORIA ROOT20 [hp_X]/mL
COPPER20 [hp_X]/mL
DRYOPTERIS FILIX-MAS ROOT20 [hp_X]/mL
GARLIC20 [hp_X]/mL
GINGER20 [hp_X]/mL
HORSE CHESTNUT20 [hp_X]/mL
IPECAC20 [hp_X]/mL
JUGLANS REGIA LEAF11 [hp_X]/mL
KRAMERIA LAPPACEA ROOT20 [hp_X]/mL
LACHESIS MUTA VENOM20 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE20 [hp_X]/mL
MERCURY20 [hp_X]/mL
NAPHTHALENE20 [hp_X]/mL
PUNICA GRANATUM ROOT BARK20 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP20 [hp_X]/mL
SANTONIN20 [hp_X]/mL
SCHOENOCAULON OFFICINALE SEED20 [hp_X]/mL
SILICON DIOXIDE20 [hp_X]/mL
SODIUM CHLORIDE20 [hp_X]/mL
SPIGELIA ANTHELMIA20 [hp_X]/mL
STRYCHNOS NUX-VOMICA SEED20 [hp_X]/mL
TEUCRIUM MARUM20 [hp_X]/mL
THYMOL20 [hp_X]/mL
TURPENTINE OIL20 [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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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55714-4859-1Para-Si30 mL in 1 BOTTLE, GLASSLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55714-4859PARA-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.]1Current NDC, 1 package rows20241127_27d5997b-1cae-41c2-e063-6394a90ac74a.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
55714-4859-15571448590130 mL in 1 BOTTLE, GLASS (55714-4859-1) 30 ml2024-11-26NoNoHistorical