FDA.reportPublic FDA data

Adrenal and DHEA

Manufacturer
ProBLEN | Apotheca Company
Effective date
2013-04-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:04:33

Label at a glance#

ProductAdrenal and DHEA
Active ingredientAMERICAN GINSENG, ARNICA MONTANA, AVENA SATIVA FLOWERING TOP, SILYBUM MARIANUM SEED, PRASTERONE, SUS SCROFA ADRENAL GLAND, ARGININE, SODIUM CHLORIDE, PHOSPHORIC ACID, THUJA OCCIDENTALIS LEAF, .ALPHA.-TOCOPHEROL
Label structure9 sections

Indications and uses

Temporarily supports the body to rebalance Adrenal and DHEA output. Symptoms of imbalanced Adrenal and DHEA may include: low energy, depression, anxiety, dry eyes, skin, and hair, loss of head hair.

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

Aralia Quinquefolia 3X, Arnica Montana 3X, Avena Sativa 3X, Carduus Marianus 3X, DHEA 6X, Glandula Suprarenalis Suis 12X, L-Arginine 6X, Natrum Muriaticum 30C, Phosphoricum Acidum 200C, Thuja Occidentalis 200C, Vitamin E 10X

INDICATIONS

OTC - PURPOSE SECTION

Temporarily supports the body to rebalance Adrenal and DHEA output.  Symptoms of imbalanced Adrenal and DHEA may include: low energy, depression, anxiety, dry eyes, skin, and hair, loss of head hair. 

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.

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

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. 

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

Purified Water, Organic Ethanol 20%

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Temporarily supports the body to rebalance Adrenal and DHEA output. Symptoms of imbalanced Adrenal and DHEA may include: low energy, depression, anxiety, dry eyes, skin, and hair, loss of head hair.

QUESTIONS

OTC - QUESTIONS SECTION

Distributed By ProBLEN

2850 Shoreline Trail

Rockwall, TX 75032

www.problen.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

ORGANOTHERAPY

Adrenal and

DHEA

1.0 FL OZ. (30 ML)

proBLEN

Adrenal and DHEAAdrenal and DHEA

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
86ca2ee7-106a-420e-9137-a9ec1af5dbc1Product name120170110
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43853-0008-32020-01-31C16284748780-19d75b9d0-6826-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43853-0008-1Adrenal and DHEA30 mL in 1 BOTTLE, SPRAYLIQUID301
43853-0008-2Adrenal and DHEA1 in 1 CARTONLIQUID11
43853-0008-3Adrenal and DHEA1 in 1 CARTONLIQUID11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43853-0008ADRENAL AND DHEA (ARALIA QUINQUEFOLIA, ARNICA MONTANA, AVENA SATIVA, CARDUUS MARIANUS, DHEA, GLANDULA SUPRARENALIS SUIS, L-ARGININE) LIQUID [PROBLEN]1Legacy NDC, 3 package rows20130502_c0718768-6f1f-43c2-8c91-e6c94af9d089.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROLACTIVE INGREDIENTH4N855PNZ11
AMERICAN GINSENGACTIVE INGREDIENT8W75VCV53Q1
ARGININEACTIVE INGREDIENT94ZLA3W45F1
ARNICA MONTANAACTIVE INGREDIENTO80TY208ZW1
AVENA SATIVA FLOWERING TOPACTIVE INGREDIENTMA9CQJ3F7F1
PHOSPHORIC ACIDACTIVE INGREDIENTE4GA8884NN1
PRASTERONEACTIVE INGREDIENT459AG36T1B1
SILYBUM MARIANUM SEEDACTIVE INGREDIENTU946SH95EE1
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8X1
SUS SCROFA ADRENAL GLANDACTIVE INGREDIENT398IYQ16YV1
THUJA OCCIDENTALIS LEAFACTIVE INGREDIENT0T0DQN87861
.ALPHA.-TOCOPHEROLACTIVE MOIETYH4N855PNZ11
AMERICAN GINSENGACTIVE MOIETY8W75VCV53Q1
ARGININEACTIVE MOIETY94ZLA3W45F1
ARNICA MONTANAACTIVE MOIETYO80TY208ZW1
AVENA SATIVA FLOWERING TOPACTIVE MOIETYMA9CQJ3F7F1
CHLORIDE IONACTIVE MOIETYQ32ZN486981
PHOSPHORIC ACIDACTIVE MOIETYE4GA8884NN1
PRASTERONEACTIVE MOIETY459AG36T1B1
SILYBUM MARIANUM SEEDACTIVE MOIETYU946SH95EE1
SUS SCROFA ADRENAL GLANDACTIVE MOIETY398IYQ16YV1
THUJA OCCIDENTALIS LEAFACTIVE MOIETY0T0DQN87861
ALCOHOLINACTIVE INGREDIENT3K9958V90M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43853-000843853-0008-1, 43853-0008-2, 43853-0008-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMERICAN GINSENG8W75VCV53QACTIB
ARNICA MONTANAO80TY208ZWACTIB
AVENA SATIVA FLOWERING TOPMA9CQJ3F7FACTIB
SILYBUM MARIANUM SEEDU946SH95EEACTIB
PRASTERONE459AG36T1BACTIB
SUS SCROFA ADRENAL GLAND398IYQ16YVACTIB
ARGININE94ZLA3W45FACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
THUJA OCCIDENTALIS LEAF0T0DQN8786ACTIB
.ALPHA.-TOCOPHEROLH4N855PNZ1ACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT

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 · 59 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
ALCOHOLALCOHOL3K9958V90MSOLUTION / OPHTHALMIC0.5 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / SUBCUTANEOUS6.1 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TRANSDERMAL7360 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, FOAM / TOPICAL4504 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / RESPIRATORY (INHALATION)0.08 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAVENOUS6405 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE / ORAL882 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSWAB / TOPICAL2250 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MMOUTHWASH / BUCCAL200 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / NASAL20 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSYRUP / ORAL21000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / SUBLINGUAL397 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TRANSDERMAL90 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / NASAL70 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TOPICAL2445 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCAPSULE, EXTENDED RELEASE / ORAL8 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / DENTAL12.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVENOUS92 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / TRANSDERMAL49.37 %w/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / ORAL3563 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / ORAL681 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / BUCCAL679 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TRANSDERMAL3675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAMUSCULAR400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, METERED / RESPIRATORY (INHALATION)26664 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / SUBCUTANEOUS149 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MCONCENTRATE / ORAL198 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLOTION / TOPICAL25 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / INTRAVENOUS400 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MTABLET, DELAYED RELEASE / ORALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAMUSCULAR1491 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / INTRAVENOUS4000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL / TOPICAL561 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, EMULSION / INTRAVENOUS520 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION, SOLUTION / INTRAMUSCULAR1000 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / NASAL10 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVESICAL7892 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY, METERED / SUBLINGUAL29 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / RECTAL898 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MELIXIR / ORAL13675 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MJELLY / VAGINALNAExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / ORAL6624 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPASTE / DENTAL1.8 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL, METERED / TOPICAL541 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MAEROSOL, SPRAY / RESPIRATORY (INHALATION)35.75 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION, CONCENTRATE / ORAL150.68 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MPOWDER, FOR SOLUTION / TOPICAL40 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSUSPENSION / RECTAL0.35 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MINJECTION / INTRAVASCULAR100 %v/vExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MDROPS / ORAL210 mg/1mlExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSHAMPOO / TOPICAL714 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSOLUTION / INTRAVENOUS99 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MLIQUID / RESPIRATORY (INHALATION)5 %w/wExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MSPRAY / TOPICAL3633 mgExact identifier — unii candidate
59 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii candidate
59 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
3992ec41-9aae-4e88-83be-6032a43e5d77c0718768-6f1f-43c2-8c91-e6c94af9d0892013-04-23WarningsExact identifier
spl id: 3992ec41-9aae-4e88-83be-6032a43e5d77
spl set id: c0718768-6f1f-43c2-8c91-e6c94af9d089

Reported adverse events (FAERS/openFDA)#

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