FDA.reportPublic FDA data

5 Chronic Stress

Manufacturer
Biotics Research Corporation | Apotheca Company
Effective date
2024-10-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 20:51:53

Label at a glance#

Product5 Chronic Stress
Active ingredientAMERICAN GINSENG, FUCUS VESICULOSUS, SOLIDAGO VIRGAUREA FLOWERING TOP, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE FLOWER, GOLDENSEAL, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, ACTIVATED CHARCOAL, CEANOTHUS AMERICANUS LEAF, CYCLAMEN PURPURASCENS TUBER, SODIUM CHLORIDE, STRYCHNOS NUX-VOMICA SEED, KEROSENE, PHOSPHORUS
Label structure9 sections

Dosage and administration

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

Aralia Quinquefolia 3X, 30C, Fucus Vesiculosus 3X, 30C, Solidago Virgaurea 3X, 30C, Taraxacum Officinale 3X, 30C, Trifolium Pratense 3X, 30C, Hydrastis Canadensis 5X, 30C, Arsenicum Album 30C, Calcarea Carbonica 30C, Carbo Vegetabilis 30C, Ceanothus Americanus 30C, Cyclamen Europaeum 30C, Hepar Sulphuris Calcareum 30C, Natrum Muriaticum 30C, Nux Vomica 30C, Petroleum30C, Phosphorus 30C.

INDICATIONS:

OTC - PURPOSE SECTION

For temporary relief of debility or exhaustion after slight exertion, or exhaustion following dysentery. Remedy #5 supports the easing of chronic stress produced by natural substances called adaptogens.

WARNINGS:

WARNINGS SECTION

If symptoms persist or worsen, seek the advice of a healthcare professional.

Caution: Not recommended for pregnant or lactating women.

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

Tamper Seal: Sealed with an imprinted safety seal for your protection. Do not use if seal is missing or broken.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

One (1) teaspoon twice daily or as otherwise directed by a healthcare professional. Consult a physician for use in children under 6 years of age.

INDICATIONS:

INDICATIONS & USAGE SECTION

For temporary relief of debility or exhaustion after slight exertion, or exhaustion following dysentery. Remedy #5 supports the easing of chronic stress produced by natural substances called adaptogens.

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Citric acid, Demineralized water, Ethanol, Sodium benzoate

QUESTIONS:

OTC - QUESTIONS SECTION

Distributed by

Biotics Research Corporation

Rosenberg, TX 77471 • (281) 344-0909

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Biotics Research Corporation's

21st CENTURY

HOMEOPATHICS

NDC #55146-005-01

HOMEOPATHIC REMEDY

#5

Chronic Stress

Water Based

Formula

(2.85% Ethanol)

4 fl. oz. (120ml)

#5 Chronic Stress#5 Chronic Stress

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55146-005-012024-10-18C16284748780-1d6a99b39-8c9b-a426-e053-dadaa90af4c2Drug Facts:
55146-005-012022-01-28C16284748780-1d6a99b39-8c9b-a426-e053-dadaa90af4c2Drug Facts:

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55146-0055 CHRONIC STRESS (ARALIA QUINQUEFOLIA, FUCUS VESICULOSUS, SOLIDAGO VIRGAUREA, TARAXACUM OFFICINALE, TRIFOLIUM PRATENSE, HYDRASTIS CANADENSIS, ARSENICUM ALBUM, CALCAREA CARBONICA, CARBO VEGETABILIS, CEANOTHUS AMERICANUS, CYCLAMEN EUROPAEUM, HEPAR SULPHURIS CALCAREUM, NATRUM MURIATICUM, NUX VOMICA, PETROLEUM, PHOSPHORUS) LIQUID [BIOTICS RESEARCH CORPORATION]6Legacy NDC20241020_6f79905b-767b-49d0-8630-7b5348f87e4d.zip

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55146-00555146-005-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
AMERICAN GINSENG8W75VCV53QACTIB
FUCUS VESICULOSUS535G2ABX9MACTIB
SOLIDAGO VIRGAUREA FLOWERING TOP5405K23S50ACTIB
TARAXACUM OFFICINALE39981FM375ACTIB
TRIFOLIUM PRATENSE FLOWER4JS0838828ACTIB
GOLDENSEALZW3Z11D0JVACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
ACTIVATED CHARCOAL2P3VWU3H10ACTIB
CEANOTHUS AMERICANUS LEAF25B1Y14T8NACTIB
CYCLAMEN PURPURASCENS TUBERG728143D8QACTIB
SODIUM CHLORIDE451W47IQ8XACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
KEROSENE1C89KKC04EACTIB
PHOSPHORUS27YLU75U4WACTIB
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
SODIUM BENZOATEOJ245FE5EUIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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
008b10c5-08ba-4a41-aed0-3a0e981877926f79905b-767b-49d0-8630-7b5348f87e4d2024-10-18WarningsExact identifier
spl id: 008b10c5-08ba-4a41-aed0-3a0e98187792
spl set id: 6f79905b-767b-49d0-8630-7b5348f87e4d

Reported adverse events (FAERS/openFDA)#

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