FDA.reportPublic FDA data

RPT-Sys

Product NDC
64616-104
11-digit product format
646160104
Labeler code
64616
Product ID
64616-104_462f5aa4-db68-26dd-e063-6294a90a4030
Type
HUMAN OTC DRUG
Nonproprietary name
Emotional Rebalance
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-04-08
Substance
APOCYNUM CANNABINUM ROOT; ASAFETIDA; EGG PHOSPHOLIPIDS; EUCALYPTUS GLOBULUS LEAF; GENTIANA LUTEA ROOT; LATHYRUS SATIVAS SEED; LYCOPODIUM CLAVATUM SPORE; NUTMEG; OXALIC ACID DIHYDRATE; PHOSPHORIC ACID; PLATINUM; SILICON DIOXIDE; SODIUM BORATE; STRYCHNOS IGNATII SEED; SUS SCROFA PITUITARY GLAND; THYROID, UNSPECIFIED; TOXICODENDRON PUBESCENS LEAF; TRILLIUM ERECTUM ROOT; WOOD CREOSOTE
Active strength
10; 6; 20; 7; 7; 20; 7; 7; 10; 8; 10; 10; 7; 10; 6; 6; 10; 3; 8 [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_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Food Additives [CS], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], 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
RPT-Sys
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
APOCYNUM CANNABINUM ROOT10 [hp_X]/mL
ASAFETIDA6 [hp_X]/mL
EGG PHOSPHOLIPIDS20 [hp_X]/mL
EUCALYPTUS GLOBULUS LEAF7 [hp_X]/mL
GENTIANA LUTEA ROOT7 [hp_X]/mL
LATHYRUS SATIVAS SEED20 [hp_X]/mL
LYCOPODIUM CLAVATUM SPORE7 [hp_X]/mL
NUTMEG7 [hp_X]/mL
OXALIC ACID DIHYDRATE10 [hp_X]/mL
PHOSPHORIC ACID8 [hp_X]/mL
PLATINUM10 [hp_X]/mL
SILICON DIOXIDE10 [hp_X]/mL
SODIUM BORATE7 [hp_X]/mL
STRYCHNOS IGNATII SEED10 [hp_X]/mL
SUS SCROFA PITUITARY GLAND6 [hp_C]/mL
THYROID, UNSPECIFIED6 [hp_C]/mL
TOXICODENDRON PUBESCENS LEAF10 [hp_X]/mL
TRILLIUM ERECTUM ROOT3 [hp_X]/mL
WOOD CREOSOTE8 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii2F92409L9Z, W9FZA51AS1, 1Z74184RGV, S546YLW6E6, S72O3284MS, 8VP54WOT4I, C88X29Y479, AEE24M3MQ9, 0K2L2IJ59O, E4GA8884NN, 49DFR088MY, ETJ7Z6XBU4, 91MBZ8H3QO, 1NM3M2487K, L0PFEMQ1DT, 0B4FDL9I6P, 6IO182RP7A, AHW6F0T2X0, 3JYG22FD73

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-104-02RPT-Sys59 mL in 1 BOTTLE, DROPPERLIQUID598

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
APOCYNUM CANNABINUM ROOTACTIVE INGREDIENT2F92409L9ZRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
ASAFETIDAACTIVE INGREDIENTW9FZA51AS1RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
EGG PHOSPHOLIPIDSACTIVE INGREDIENT1Z74184RGVRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
EUCALYPTUS GLOBULUS LEAFACTIVE INGREDIENTS546YLW6E6RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
GENTIANA LUTEA ROOTACTIVE INGREDIENTS72O3284MSRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
LATHYRUS SATIVAS SEEDACTIVE INGREDIENT8VP54WOT4IRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE INGREDIENTC88X29Y479RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
NUTMEGACTIVE INGREDIENTAEE24M3MQ9RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
OXALIC ACID DIHYDRATEACTIVE INGREDIENT0K2L2IJ59ORPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NNRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
PLATINUMACTIVE INGREDIENT49DFR088MYRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
SILICON DIOXIDEACTIVE INGREDIENTETJ7Z6XBU4RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
Sodium BorateACTIVE INGREDIENT91MBZ8H3QORPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
STRYCHNOS IGNATII SEEDACTIVE INGREDIENT1NM3M2487KRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
SUS SCROFA PITUITARY GLANDACTIVE INGREDIENTE8S87O660TRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
THYROID, UNSPECIFIEDACTIVE INGREDIENT0B4FDL9I6PRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7ARPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
TRILLIUM ERECTUM ROOTACTIVE INGREDIENTAHW6F0T2X0RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
WOOD CREOSOTEACTIVE INGREDIENT3JYG22FD73RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
APOCYNUM CANNABINUM ROOTACTIVE MOIETY2F92409L9ZRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
ASAFETIDAACTIVE MOIETYW9FZA51AS1RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
BORATE IONACTIVE MOIETY44OAE30D22RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
COLLOIDAL SILICON DIOXIDEACTIVE MOIETYETJ7Z6XBU4RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
EGG PHOSPHOLIPIDSACTIVE MOIETY1Z74184RGVRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
EUCALYPTUS GLOBULUS LEAFACTIVE MOIETYS546YLW6E6RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
GENTIANA LUTEA ROOTACTIVE MOIETYS72O3284MSRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
LATHYRUS SATIVAS SEEDACTIVE MOIETY8VP54WOT4IRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
LYCOPODIUM CLAVATUM SPOREACTIVE MOIETYC88X29Y479RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
NUTMEGACTIVE MOIETYAEE24M3MQ9RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
OXALIC ACIDACTIVE MOIETY9E7R5L6H31RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NNRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
PLATINUMACTIVE MOIETY49DFR088MYRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
STRYCHNOS IGNATII SEEDACTIVE MOIETY1NM3M2487KRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
SUS SCROFA PITUITARY GLANDACTIVE MOIETYE8S87O660TRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
THYROID, UNSPECIFIEDACTIVE MOIETY0B4FDL9I6PRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7ARPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
TRILLIUM ERECTUM ROOTACTIVE MOIETYAHW6F0T2X0RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
WOOD CREOSOTEACTIVE MOIETY3JYG22FD73RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RRPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-104RPT-SYS (EMOTIONAL REBALANCE) LIQUID [VITALITY WORKS, INC.]7Current NDC, Legacy NDC, 1 package rows20241212_0e8768fe-c2ba-41e9-93ac-c142fae6e879.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-104-026461601040259 mL in 1 BOTTLE, DROPPER (64616-104-02) 59 ml2013-04-080000-00-00NoNoCurrent