FDA.reportPublic FDA data

TOTAL PRO-JES

Manufacturer
White Manufacturing Inc. BDA Micro-West
Effective date
2021-01-21
Label type
HUMAN OTC DRUG LABEL
Version
18
Source
full-release
Hydrated at
2026-06-01 02:14:15

Label at a glance#

ProductTOTAL PRO-JES
Active ingredientPROGESTERONE, EPINEPHRINE, ATROPA BELLADONNA, CHELIDONIUM MAJUS, DIOSCOREA VILLOSA ROOT, ESTRONE, BOS TAURUS HYPOTHALAMUS, ARGININE, LILIUM LANCIFOLIUM FLOWERING TOP, MAMMAL LIVER, SUS SCROFA OVARY, BOS TAURUS PINEAL GLAND, BOS TAURUS PITUITARY GLAND, SUS SCROFA PLACENTA, PULSATILLA VULGARIS, SEPIA OFFICINALIS JUICE, SULFUR
Label structure10 sections

Indications and uses

hot flashes, irritable disposition, liver, uterine, vaginal and sleep complaints

Dosage and administration

DIRECTIONS :Use day 11 thru 22 of the normal menstrual cycle, even if menses has ceased. If cycle dates are unknown, make day 11 as the first day of the calendar month. Take 6 drops orally, 4 times a day. For ages 12 to adult.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Belladonna 6C

Chelidonium maj 6C

Dioscorea 6C

Folliculinum 6C

Glandula suprarenalis suis 6C

Hepar Suis 6C

Hypothalamus 6C

Lilium 12C

Oophorinum 6C

Pituitarum posterium 8X

Placenta totalis suis 6X

Pulsatilla 12C

Sepia 12C

Sulphur 12C

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Alcohol (20% v/v)

Purified water

USES

OTC - PURPOSE SECTION

hot flashes, irritable disposition, liver, uterine, vaginal and sleep complaints

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF REACH OF CHILDREN

INDICATIONS

INDICATIONS & USAGE SECTION

INDICATIONS: For the temporary relief of hot flashes, irritable disposition, liver, uterine, vaginal and sleep complaints.

WARNING

WARNINGS SECTION

WARNING: STOP USE AND CALL A DOCTOR if symptoms persist or worsen. CONTAINS ALCOHOL: in case of accidental overdose, consult a poison control center immediately.

OTHER INFORMATION: Tamper resistant for your protection. Use only if safety seal is intact.

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS:Use day 11 thru 22 of the normal menstrual cycle, even if menses has ceased. If cycle dates are unknown, make day 11 as the first day of the calendar month. Take 6 drops orally, 4 times a day. For ages 12 to adult.

PREGNANCY

OTC - PREGNANCY OR BREAST FEEDING SECTION

IF PREGNANT OR BREAST FEEDING, consult a healthcare professional before use.

MANUFACTURE

SPL UNCLASSIFIED SECTION

MANUFACTURED FOR

MICRO-WEST

P.O. Box 950

DOUGLAS, WY 82633

1-307-358-5066

LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 61657-0974-1

MICRO-WEST

Homeopathic

TOTAL PRO-JES

Product #: 0974

1.0 fl oz Bottle Label1.0 fl oz Bottle Label

1.0 fl oz (29.6 mL)

Ethanol 20%

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
61657-0974-1TOTAL PRO-JES30 mL in 1 BOTTLE, DROPPERLIQUID3018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61657-0974TOTAL PRO-JES (ADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONE) LIQUID [WHITE MANUFACTURING INC. BDA MICRO-WEST]18Current NDC, Legacy NDC, 1 package rows20210123_b26953f8-7b56-432c-958c-d80c528fbb6a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ARGININEACTIVE INGREDIENT94ZLA3W45F16
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H16
BOS TAURUS HYPOTHALAMUSACTIVE INGREDIENTS6G2NLH4Y716
BOS TAURUS PINEAL GLANDACTIVE INGREDIENTZ7RM5NBH3616
BOS TAURUS PITUITARY GLANDACTIVE INGREDIENT7JM57I419K16
CHELIDONIUM MAJUSACTIVE INGREDIENT7E889U5RNN16
DIOSCOREA VILLOSA ROOTACTIVE INGREDIENTIWY3IWX2G816
EPINEPHRINEACTIVE INGREDIENTYKH834O4BH16
ESTRONEACTIVE INGREDIENT2DI9HA706A16
LILIUM LANCIFOLIUM FLOWERING TOPACTIVE INGREDIENT6268MFA91716
MAMMAL LIVERACTIVE INGREDIENTD0846624BI16
PROGESTERONEACTIVE INGREDIENT4G7DS2Q64Y16
PULSATILLA VULGARISACTIVE INGREDIENTI76KB35JEV16
SEPIA OFFICINALIS JUICEACTIVE INGREDIENTQDL83WN8C216
SULFURACTIVE INGREDIENT70FD1KFU7016
SUS SCROFA OVARYACTIVE INGREDIENTS7YTV04R8O16
SUS SCROFA PLACENTAACTIVE INGREDIENTC8CV8867O816
ARGININEACTIVE MOIETY94ZLA3W45F16
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H16
BOS TAURUS HYPOTHALAMUSACTIVE MOIETYS6G2NLH4Y716
BOS TAURUS PINEAL GLANDACTIVE MOIETYZ7RM5NBH3616
BOS TAURUS PITUITARY GLANDACTIVE MOIETY7JM57I419K16
CHELIDONIUM MAJUSACTIVE MOIETY7E889U5RNN16
DIOSCOREA VILLOSA ROOTACTIVE MOIETYIWY3IWX2G816
EPINEPHRINEACTIVE MOIETYYKH834O4BH16
ESTRONEACTIVE MOIETY2DI9HA706A16
LILIUM LANCIFOLIUM FLOWERING TOPACTIVE MOIETY6268MFA91716
MAMMAL LIVERACTIVE MOIETYD0846624BI16
PROGESTERONEACTIVE MOIETY4G7DS2Q64Y16
PULSATILLA VULGARISACTIVE MOIETYI76KB35JEV16
SEPIA OFFICINALIS JUICEACTIVE MOIETYQDL83WN8C216
SULFURACTIVE MOIETY70FD1KFU7016
SUS SCROFA OVARYACTIVE MOIETYS7YTV04R8O16
SUS SCROFA PLACENTAACTIVE MOIETYC8CV8867O816
ALCOHOLINACTIVE INGREDIENT3K9958V90M16

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
61657-097461657-0974-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALCOHOL3K9958V90MIACT
PROGESTERONE4G7DS2Q64YACTIB
EPINEPHRINEYKH834O4BHACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
CHELIDONIUM MAJUS7E889U5RNNACTIB
DIOSCOREA VILLOSA ROOTIWY3IWX2G8ACTIB
ESTRONE2DI9HA706AACTIB
BOS TAURUS HYPOTHALAMUSS6G2NLH4Y7ACTIB
ARGININE94ZLA3W45FACTIB
LILIUM LANCIFOLIUM FLOWERING TOP6268MFA917ACTIB
MAMMAL LIVERD0846624BIACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
BOS TAURUS PINEAL GLANDZ7RM5NBH36ACTIB
BOS TAURUS PITUITARY GLAND7JM57I419KACTIB
SUS SCROFA PLACENTAC8CV8867O8ACTIB
PULSATILLA VULGARISI76KB35JEVACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
SULFUR70FD1KFU70ACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TOTAL PRO-JESADRENAL,BELLADONNA,CHELIDONIUM,DIOSCOREAVILLOSA,FOLLICULINUM,HYPOTHALAMUS,ARGININE,LILIUMTIGRINIUM,LIVER,OOPHORINUM,PINEAL,PITUITARINUM,PLACENTANIUM,PROGESTERONEWhite Manufacturing Inc. BDA Micro-Westb26953f8-7b56-432c-958c-d80c528fbb6a2021-01-21WarningsExact identifier
ndc (package): 61657-0974-1
ndc (product): 61657-0974
ndc11 (package): 61657097401
spl id: b9702889-9e53-da42-e053-2995a90a45de
spl set id: b26953f8-7b56-432c-958c-d80c528fbb6a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.