FDA.reportPublic FDA data

Fem Repair Non-Preg

Product NDC
64616-090
11-digit product format
646160090
Labeler code
64616
Product ID
64616-090_462f6266-da9b-e9af-e063-6394a90a2035
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Fem Glandular and Tissue Aid
Dosage form
LIQUID
Route
ORAL
Labeler
Vitality Works, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2013-04-08
Substance
ANTIMONY ARSENATE; CENTELLA ASIATICA; CHIONANTHUS VIRGINICUS BARK; CHRYSOPOGON ZIZANIOIDES ROOT; CLAVICEPS PURPUREA SCLEROTIUM; DAPHNE MEZEREUM BARK; GENTIANA LUTEA ROOT; MERCURIUS SOLUBILIS; OXALIC ACID DIHYDRATE; POTASSIUM PHOSPHATE, DIBASIC; RUTA GRAVEOLENS FLOWERING TOP; SOLIDAGO VIRGAUREA FLOWERING TOP; SUS SCROFA PITUITARY GLAND; VALERIANA OFFICINALIS WHOLE; ZINC OXIDE
Active strength
14; 6; 6; 6; 7; 15; 6; 12; 10; 20; 6; 20; 6; 6; 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_C]/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

Additional Listing Data#

Finished product
Yes
Brand name base
Fem Repair Non-Preg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ANTIMONY ARSENATE14 [hp_X]/mL
CENTELLA ASIATICA6 [hp_X]/mL
CHIONANTHUS VIRGINICUS BARK6 [hp_X]/mL
CHRYSOPOGON ZIZANIOIDES ROOT6 [hp_X]/mL
CLAVICEPS PURPUREA SCLEROTIUM7 [hp_X]/mL
DAPHNE MEZEREUM BARK15 [hp_X]/mL
GENTIANA LUTEA ROOT6 [hp_X]/mL
MERCURIUS SOLUBILIS12 [hp_X]/mL
OXALIC ACID DIHYDRATE10 [hp_X]/mL
POTASSIUM PHOSPHATE, DIBASIC20 [hp_X]/mL
RUTA GRAVEOLENS FLOWERING TOP6 [hp_X]/mL
SOLIDAGO VIRGAUREA FLOWERING TOP20 [hp_X]/mL
SUS SCROFA PITUITARY GLAND6 [hp_C]/mL
VALERIANA OFFICINALIS WHOLE6 [hp_X]/mL
ZINC OXIDE15 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
UniiWE3458XNFT, 7M867G6T1U, 37TB8LUP9Z, 01G9XEA93N, X2N6E405GV, S72O3284MS, 324Y4038G2, 0K2L2IJ59O, CI71S98N1Z, N94C2U587S, 5405K23S50, L0PFEMQ1DT, FP6O7F1X9R, SOI2LOH54Z

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64616-090-02Fem Repair Non-Preg59 mL in 1 BOTTLE, DROPPERLIQUID598

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ANTIMONY ARSENATEACTIVE INGREDIENTWE3458XNFTFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CENTELLA ASIATICAACTIVE INGREDIENT7M867G6T1UFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CHIONANTHUS VIRGINICUS BARKACTIVE INGREDIENTS9Y4B22U2EFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CHRYSOPOGON ZIZANIOIDES ROOTACTIVE INGREDIENT37TB8LUP9ZFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CLAVICEPS PURPUREA SCLEROTIUMACTIVE INGREDIENT01G9XEA93NFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
DAPHNE MEZEREUM BARKACTIVE INGREDIENTX2N6E405GVFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
GENTIANA LUTEA ROOTACTIVE INGREDIENTS72O3284MSFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
MERCURIUS SOLUBILISACTIVE INGREDIENT324Y4038G2FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
OXALIC ACID DIHYDRATEACTIVE INGREDIENT0K2L2IJ59OFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
POTASSIUM PHOSPHATE, DIBASICACTIVE INGREDIENTCI71S98N1ZFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
RUTA GRAVEOLENS FLOWERING TOPACTIVE INGREDIENTN94C2U587SFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE INGREDIENT5405K23S50FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
SUS SCROFA PITUITARY GLANDACTIVE INGREDIENTE8S87O660TFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
VALERIANA OFFICINALIS WHOLEACTIVE INGREDIENTFP6O7F1X9RFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
ARSENATE IONACTIVE MOIETYG1DBI405OKFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CENTELLA ASIATICAACTIVE MOIETY7M867G6T1UFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CHIONANTHUS VIRGINICUS BARKACTIVE MOIETYS9Y4B22U2EFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CHRYSOPOGON ZIZANIOIDES ROOTACTIVE MOIETY37TB8LUP9ZFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
CLAVICEPS PURPUREA SCLEROTIUMACTIVE MOIETY01G9XEA93NFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
DAPHNE MEZEREUM BARKACTIVE MOIETYX2N6E405GVFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
GENTIANA LUTEA ROOTACTIVE MOIETYS72O3284MSFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
MERCURIUS SOLUBILISACTIVE MOIETY324Y4038G2FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
OXALIC ACIDACTIVE MOIETY9E7R5L6H31FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
PHOSPHATE IONACTIVE MOIETYNK08V8K8HRFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
RUTA GRAVEOLENS FLOWERING TOPACTIVE MOIETYN94C2U587SFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
SOLIDAGO VIRGAUREA FLOWERING TOPACTIVE MOIETY5405K23S50FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
SUS SCROFA PITUITARY GLANDACTIVE MOIETYE8S87O660TFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
VALERIANA OFFICINALIS WHOLEACTIVE MOIETYFP6O7F1X9RFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
ZINC CATIONACTIVE MOIETY13S1S8SF37FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RFEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
64616-090FEM REPAIR NON-PREG (FEM GLANDULAR AND TISSUE AID) LIQUID [VITALITY WORKS, INC.]7Current NDC, Legacy NDC, 1 package rows20241212_230fa998-20ef-46ef-8252-7ac87b58040b.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
64616-090-026461600900259 mL in 1 BOTTLE, DROPPER (64616-090-02) 59 ml2013-04-080000-00-00NoNoCurrent