FDA.reportPublic FDA data

Stress

Manufacturer
Zorex International | OHM Pharma, Inc
Effective date
2018-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:20:56

Label at a glance#

ProductStress
Active ingredientAMERICAN GINSENG, PASSIFLORA INCARNATA FLOWERING TOP, SCUTELLARIA LATERIFLORA WHOLE, VALERIAN, ARSENIC TRIOXIDE, GOLD, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ARABICA COFFEE BEAN, STRYCHNOS IGNATII SEED, DIBASIC POTASSIUM PHOSPHATE, LYCOPUS VIRGINICUS WHOLE, PHOSPHORUS, DELPHINIUM STAPHISAGRIA SEED
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: Aralia Quin 6X, Passiflora 6X, Scutellaria 6X, Valeriana 6X, Arsenicum Alb 12X, Aur Met 12X, Calc Carb 12X, Coffea Cruda 12X, Ignatia 12X, Kali Phos 12X, Lycopus 12X, Phosphorus 12X, Staphysagria 12X

INDICATIONS & USAGE SECTION

USES: Temporarily relieves symptoms of simple nervous tension.**

OTC - PURPOSE SECTION

USES: Temporarily relieves symptoms of simple nervous tension.**

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS: Adults & children above 12 years: 10 drops orally 3 times daily, or as directed by a health care professional.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.

WARNINGS SECTION

WARNINGS:

  • Consult a physician for use in children under 12 years of age.
  • IF PREGNANT OR BREAST-FEEDING, ask a health care professional before use.
  • KEEP OUT OF THE REACH OF CHILDREN. In case of overdose (or accidental ingestion) get medical help or contact a Poison Control Center right away.
  • Do not use if TAMPER EVIDENT seal is broken or missing.

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: Ethyl Alcohol USP, Purified Water

OTC - QUESTIONS SECTION

QUESTIONS & COMMENTS?

Zorex International / Lowell, MI 49331 / 800-679-3027

REFERENCES SECTION

*The letters "HPUS" indicate the components in the product are officially monographed in the Homeopathic Pharmacopeia of the United States.

**Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC:81825-0010-1

Stress

HOMEOPATHIC

1 fl oz (30mL) / 20% Alcohol

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
4b7700e3-6e0e-45e5-9d22-6f754d61386eProduct name220250304
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81825-0010-1Stress30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81825-0010STRESS (ARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIA) LIQUID [ZOREX INTERNATIONAL]1Current NDC, 1 package rows20230420_d0527396-7b7f-4252-be0f-d3aa74c25e0e.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
81825-001081825-0010-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMERICAN GINSENG8W75VCV53QACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
SCUTELLARIA LATERIFLORA WHOLE7BP4DH5PDCACTIB
VALERIANJWF5YAW3QWACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
GOLD79Y1949PYOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
ARABICA COFFEE BEAN3SW678MX72ACTIB
STRYCHNOS IGNATII SEED1NM3M2487KACTIB
DIBASIC POTASSIUM PHOSPHATECI71S98N1ZACTIB
LYCOPUS VIRGINICUS WHOLETWH5125Q6FACTIB
PHOSPHORUS27YLU75U4WACTIB
DELPHINIUM STAPHISAGRIA SEED00543AP1JVACTIB
ALCOHOL3K9958V90MIACT
WATER059QF0KO0RIACT

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
StressARALIA QUIN, PASSIFLORA, SCUTELLARIA, VALERIANA, ARSENICUM ALB, AUR MET, CALC CARB, COFFEA CRUDA, IGNATIA, KALI PHOS, LYCOPUS, PHOSPHORUS, STAPHYSAGRIAZorex Internationald0527396-7b7f-4252-be0f-d3aa74c25e0e2018-12-21WarningsExact identifier
ndc (package): 81825-0010-1
ndc (product): 81825-0010
ndc11 (package): 81825001001
spl id: b8371d3e-0e08-478c-8713-561e4672efb6
spl set id: d0527396-7b7f-4252-be0f-d3aa74c25e0e

Reported adverse events (FAERS/openFDA)#

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