FDA.reportPublic FDA data

Stress and Tension Relief

Manufacturer
Similasan Corporation
Effective date
2013-07-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 02:04:47

Label at a glance#

ProductStress and Tension Relief
Active ingredientASAFETIDA, CRATAEGUS FRUIT, LYCOPUS VIRGINICUS, PASSIFLORA INCARNATA FLOWERING TOP
Label structure15 sections

Indications and uses

Relieves symptoms of stress and simple nervous tension- - inner tension with palpitations - inner tension with gastro-intestinal cramps and nervous constipation - nervous digestive disorders - nervous sleeplessness, general irritability and tension

Dosage and administration

For adults and children ages 2 and above: - twist cap off bottle breaking tamper-evident seal - unscrew cap from bottle - dispense 7-10 globules, for best results allow to dissolve in moith - take as needed up to every half hour

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Asa foetida 4X

Purpose

OTC - PURPOSE SECTION

apprehension, irritability, restlessness

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Crataegus 4X

Purpose

OTC - PURPOSE SECTION

nervousness, restless sleep

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Lycopus virginicus 3X

Purpose

OTC - PURPOSE SECTION

inner tension, palpitations

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Passiflora 4X

Purpose

OTC - PURPOSE SECTION

restless sleep from exhaustion

Uses:

INDICATIONS & USAGE SECTION

Relieves symptoms of stress and simple nervous tension-
- inner tension with palpitations
- inner tension with gastro-intestinal cramps and nervous constipation
- nervous digestive disorders
- nervous sleeplessness, general irritability and tension

Warnings:

WARNINGS SECTION

- Consult a physician before use if pregnant or breast feeding.
- Consult a physician if symptoms persist for more than 2 weeks or worsen.
- Keep this and all medications out of the reach of children.
- Do not use if tamper-evident seal is broken.
- In case of accidental overdose, get medical help or contact a Poison Control Center immediately.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all medications out of the reach of children

Directions:

DOSAGE & ADMINISTRATION SECTION

For adults and children ages 2 and above:
- twist cap off bottle breaking tamper-evident seal
- unscrew cap from bottle
- dispense 7-10 globules, for best results allow to dissolve in moith
- take as needed up to every half hour

Other information:

SPL UNCLASSIFIED SECTION

Active ingredients are microdiluted in accordance with the Homeopathic Pharmacopoeia of the United States, and are therefore non-toxic and have no known side effects.

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Calcium carbonate, Xylitol (Sugar-free)

Questions?

OTC - QUESTIONS SECTION

Call 1-800-240-9780 for 24hr recorded product information. Representatives available, M-F, 8am-5pm (MT), or visit: www.SimilasanUSA.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-600-30
Similasan
Stress & Tension Relief
Globules
15g/ 0.529 oz

Stress and Tension Relief box
Stress and Tension Relief box

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130094841610108GTIN-13: 0094841610108
EAN-13: 0094841610108
GTIN-12: 094841610108
UPC-A: 094841610108
GTIN storage (14 digits): 00094841610108		stress-and-tension-relief-1.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-600-302020-01-31C16284748780-19d75b9d0-c24d-f424-e053-dadaa90a57ceStress and Tension Relief

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-600-30Stress and Tension Relief1078 in 1 BOTTLE, GLASSGLOBULE10785

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-600STRESS AND TENSION RELIEF (ASAFETIDA, CRATAEGUS FRUIT, LYCOPUS VIRGINICUS AND PASSIFLORA INCARNATA FLOWERING TOP) GLOBULE [SIMILASAN CORPORATION]5Legacy NDC, 1 package rows20130731_18312baf-784c-4343-8e30-8864cc47d98c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-600-30GM - Gram59262-6008d980191-7e48-4009-bf03-8d56145ef11112016-06-14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASAFETIDAACTIVE INGREDIENTW9FZA51AS15
CRATAEGUS FRUITACTIVE INGREDIENTQ21UUL21055
LYCOPUS VIRGINICUSACTIVE INGREDIENTTWH5125Q6F5
PASSIFLORA INCARNATA FLOWERING TOPACTIVE INGREDIENTCLF5YFS11O5
ASAFETIDAACTIVE MOIETYW9FZA51AS15
CRATAEGUS FRUITACTIVE MOIETYQ21UUL21055
LYCOPUS VIRGINICUSACTIVE MOIETYTWH5125Q6F5
PASSIFLORA INCARNATA FLOWERING TOPACTIVE MOIETYCLF5YFS11O5
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK5
XYLITOLINACTIVE INGREDIENTVCQ006KQ1E5

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-60059262-600-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASAFETIDAW9FZA51AS1ACTIB
CRATAEGUS FRUITQ21UUL2105ACTIB
LYCOPUS VIRGINICUSTWH5125Q6FACTIB
PASSIFLORA INCARNATA FLOWERING TOPCLF5YFS11OACTIB
CALCIUM CARBONATEH0G9379FGKIACT
XYLITOLVCQ006KQ1EIACT

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 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION, EXTENDED RELEASE / ORAL9000 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, EXTENDED RELEASE / ORAL2752 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESOLUTION / ORAL21600 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, DELAYED RELEASE / ORAL8.4 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKFILM, SOLUBLE / ORAL14 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, FILM COATED / ORAL300 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / AURICULAR (OTIC)0.38 %w/wExact identifier — unii candidate
15 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPOWDER, FOR SUSPENSION / ORAL4223 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESPRAY / SUBLINGUAL22 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET / ORAL15.04 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, EXTENDED RELEASE / ORAL229.7 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, COATED / ORAL64.8 mgExact identifier — unii candidate
15 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EGUM, CHEWING / BUCCAL11915 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EFILM, SOLUBLE / ORAL29 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / INTRAVENOUS4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, ORALLY DISINTEGRATING / ORAL360 mgExact identifier — unii candidate
12 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ESUSPENSION / ORAL1500 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE / ORAL349.9 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKSOLUTION / RESPIRATORY (INHALATION)4.02 %w/vExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, EXTENDED RELEASE / ORAL4 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKGUM, CHEWING / BUCCAL3492 mgExact identifier — unii candidate
15 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1ETABLET, FILM COATED, EXTENDED RELEASE / ORAL72 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKPOWDER, DENTIFRICE / DENTAL0.5 mg/mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii candidate
15 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKCAPSULE, DELAYED RELEASE / ORAL20 mgExact identifier — unii candidate
15 equally ranked IID candidates
XYLITOLXYLITOLVCQ006KQ1EPASTE / ORAL180 mgExact identifier — unii candidate
12 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET, CHEWABLE / ORAL1650 mgExact identifier — unii candidate
15 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
6c6fc30f-6221-42ac-a510-b39ae42ba85a18312baf-784c-4343-8e30-8864cc47d98c2013-07-31WarningsExact identifier
spl id: 6c6fc30f-6221-42ac-a510-b39ae42ba85a
spl set id: 18312baf-784c-4343-8e30-8864cc47d98c

Reported adverse events (FAERS/openFDA)#

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