FDA.reportPublic FDA data

Estrogen and Progesterone

Manufacturer
ProBLEN | Apotheca Company
Effective date
2017-01-12
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:30

Label at a glance#

ProductEstrogen and Progesterone
Active ingredientCHASTE TREE, ANGELICA SINENSIS ROOT, APIS MELLIFERA, ARNICA MONTANA, BLACK COHOSH, ESTRADIOL, ESTRIOL, ESTRONE, GALIUM APARINE, GLYCYRRHIZA GLABRA, ASIAN GINSENG, SUS SCROFA OVARY, PROGESTERONE, SEPIA OFFICINALIS JUICE, THUJA OCCIDENTALIS LEAFY TWIG, VISCUM ALBUM FRUITING TOP
Label structure9 sections

Dosage and administration

Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Agnus Castus 3X, Angelica Sinensis 3X, Apis Mellifica 6X, Arnica Montana 6X, Cimicifuga Racemosa 3X, Estradiol 9C, Estriol 9C, Folliculinum 9C, Galium Aparine 3X, Glycyrrhiza Glabra 3X, Korean Ginseng 3X, Oophorinum (Suis) 30C, Progesterone 6X, Sepia 30C, Thuja Occidentalis 6X, Viscum Album 3X

INDICATIONS:

OTC - PURPOSE SECTION

Temporarily supports the body to rebalance estrogen output.  Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

WARNINGS:

WARNINGS SECTION

Not for use on children.

If symptoms continue to recur, or if sleeplessness persists continuously for more than two weeks, consult a physician. Insomnia may be a symptom of a serious underlying medical illness.

As with all medicines, if you are pregnant or breast feeding, consult a health professional before using this product.

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Tamper Evident. There is a seal around the neck of the bottle. Do not use if this seal is broken or missing.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Adults: Hold the spray-top close to your open mouth and spray twice directly under your tongue, three times a day. Some people notice improvement within two or three weeks, others take longer.

INDICATIONS:

INDICATIONS & USAGE SECTION

Temporarily supports the body to rebalance estrogen output. Symptoms may include: mood swings, hot flashes, irritability, lack of energy.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Organic Alcohol 30% v/v, Purified Water

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed By ProBLEN
2850 Shoreline Trail,
Rockwall, TX 75032
www.problen.com

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

ORGANOTHERAPY

Estro

gen

&

Progesterone

1.0 FL. OZ. (30ML)

proBLEN

Estrogen & Progesterone lblEstrogen & Progesterone lbl

Estrogen & Progesterone ctnEstrogen & Progesterone ctn

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
5bec24fd-caeb-8b32-1ff0-ca0dd1751379Product name220250618
3fcaf367-cbc2-4d1e-845e-e1ce4b0d86a6Product name220250616
4ca088c7-0c0e-114d-ffaa-d1b94f9eadc1Product name620250311
99d68ea7-fba4-0d7b-b5fa-468e21dd1cbfProduct name220250204
a1c50ef5-9c2c-d846-1ca1-70fabf2428e1Product name320240507
66263a7f-f64d-41c4-90f1-2cee106617ccProduct name120240501
b46148e2-ee15-98d5-12f0-f5ec8745f6fcProduct name320220927
76820076-f087-4073-b1d1-aa04b361335eProduct name220220921
132e7bcf-ca42-94e4-3c78-c44ae7819a94Product name320220126
0a040ba8-1f34-4328-bb07-4f64503daaabProduct name220210513
833edb59-a012-45c2-aff5-2ed74b66fa59Product name120201207
d3229c1a-4e51-4e04-9b13-00d24fd35242Product name120200821
f4d31098-441e-52d3-27f1-49c829f8a3a1Product name520190703
001f367b-fa14-49a0-865b-b395f2553601Product name220190611
213f0591-95c1-b398-40b7-08b31f66b026Product name420190206
3f090665-4687-4bb4-8790-8efb1930ee74Product name120180801
7a549f52-8b99-472c-8b1d-3a70c53c9bf4Product name120160623
16fd7d69-0da3-423a-f064-01fb62860837Product name120140508
3ca8d96e-517a-05ea-5690-f8e1d3726540Product name120140508
5f44c957-835a-ada0-662f-5b1071b7a68bProduct name120140508
7d6c8f26-fe65-2465-c993-66dd6e1c1183Product name120140508
83cac4be-cfee-33c1-5b8e-bb83ae18bce4Product name120140508
85b2d644-53b2-f2dc-4dbc-859116ce56c0Product name120140508
c3f7be78-e6d7-47c9-c840-70c566e8d5c4Product name120140508
d048f0e3-3c40-8816-8c5c-0ca5cd189aacProduct name120140508
d6b36b6b-65d6-a810-0fa7-61ddf1a96352Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43853-0017-1Estrogen and Progesterone30 mL in 1 BOTTLE, SPRAYSPRAY301
43853-0017-2Estrogen and Progesterone1 in 1 CARTONSPRAY11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43853-0017ESTROGEN AND PROGESTERONE (AGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUM) SPRAY [PROBLEN]1Current NDC, Legacy NDC, 2 package rows20170112_71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf.zip

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
43853-001743853-0017-1, 43853-0017-2

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
CHASTE TREE433OSF3U8AACTIB
ANGELICA SINENSIS ROOTB66F4574UGACTIB
APIS MELLIFERA7S82P3R43ZACTIB
ARNICA MONTANAO80TY208ZWACTIB
BLACK COHOSHK73E24S6X9ACTIB
ESTRADIOL4TI98Z838EACTIB
ESTRIOLFB33469R8EACTIB
ESTRONE2DI9HA706AACTIB
GALIUM APARINEZ4B6561488ACTIB
GLYCYRRHIZA GLABRA2788Z9758HACTIB
ASIAN GINSENGCUQ3A77YXIACTIB
SUS SCROFA OVARYS7YTV04R8OACTIB
PROGESTERONE4G7DS2Q64YACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
THUJA OCCIDENTALIS LEAFY TWIG1NT28V9397ACTIB
VISCUM ALBUM FRUITING TOPBK9092J5MPACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

Source Document#

Source XML

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
Estrogen and ProgesteroneAGNUS CASTUS, ANGELICA SINENSIS, APIS MELLIFICA, ARNICA MONTANA, CIMICIFUGA RACEMOSA, ESTRADIOL, ESTRIOL, FOLLICULINUM, GALIUM APARINE, GLYCYRRHIZA GLABRA, KOREAN GINSENG, OOPHORINUM (SUIS), PROGESTERONE, SEPIA, THUJA OCCIDENTALIS, VISCUM ALBUMProBLEN71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf2017-01-12WarningsExact identifier
ndc (package): 43853-0017-1
ndc (package): 43853-0017-2
ndc (product): 43853-0017
ndc11 (package): 43853001702
ndc11 (package): 43853001701
spl id: 31103d8c-5ee4-483e-bd45-aac9eda84b68
spl set id: 71fec93b-43b7-4ebb-ab5c-5f544d8e6cbf

Reported adverse events (FAERS/openFDA)#

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