FDA.reportPublic FDA data

STRESS / FATIGUE

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2022-03-03
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 02:19:35

Label at a glance#

ProductSTRESS / FATIGUE
Active ingredientEPINEPHRINE, THYROID, UNSPECIFIED, BOS TAURUS PITUITARY GLAND, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, ZANTHOXYLUM AMERICANUM BARK
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS (HPUS*) - equal amounts of: ​Adrenalinum 6X, Pituitary Gland 6X, Thyroidinum 6X, Arsenicum Alb 12X, Calc Carb 12X, Conium 12X, Cortisone Aceticum 12X, Crotalus Hor 12X, Ferrum Met 12X, Nux Vomica 12X, Phosphoricum Ac 12X, Phosphorus 12X, Selenium 12X Sepia 12X, Xanthoxylum 30C.

OTC - PURPOSE SECTION

Uses:  Temporarily relieves symptoms of stress, fatigue, and simple nervous tension.**

INDICATIONS & USAGE SECTION

Uses: Temporarily relieves symptoms of stress, fatigue, and 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

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.

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?

Natural Creations, Inc. / Woodbine, IA 51579 / 712-647-1600

REFERENCES SECTION

*The letters "HPUS" indicate the components in this 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: 43406-0612-1

STRESS / FATIGUE

HOMEOPATHIC

1 fl oz (30 mL) 20% Alcohol

UPC: 877730004505 NON GMO Logo

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
86fffa7b-d382-4771-a253-25cccb64b590Product name320251124
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
910c1bd7-67d1-44c7-ad4f-9445f827edccProduct name120230808
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
2686d634-e712-4007-8dbf-3d37c6c4d71fProduct name120181121
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
bd49bb86-2d32-4a7a-a594-eeda2e29af42Product name120180118
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
3becbe78-12d9-4ad2-9b4c-1e36f8d1303aProduct name120170815
9bfd9c37-f773-6e9a-5f6b-6f5701d62adcProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0612-12022-03-03C16284748780-1d6a99b39-ed75-a426-e053-dadaa90af4c2STRESS / FATIGUE
43406-0612-12022-01-28C16284748780-1d6a99b39-ed75-a426-e053-dadaa90af4c2STRESS / FATIGUE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0612-1STRESS / FATIGUE30 mL in 1 BOTTLE, DROPPERLIQUID306

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0612STRESS / FATIGUE (EPINEPHRINE, THYROID UNSPECIFIED,BOS TAURUS PITUITARY GLAND, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, ZANTHOXYLUM AMERICANUM BARK) LIQUID [NATURAL CREATIONS, INC.]6Current NDC, Legacy NDC, 1 package rows20230113_4c28ec7f-4490-4106-8472-d94c7073c306.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-061243406-0612-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINEYKH834O4BHACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
BOS TAURUS PITUITARY GLAND7JM57I419KACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
CONIUM MACULATUM FLOWERING TOPQ28R5GF371ACTIB
CORTISONE ACETATE883WKN7W8XACTIB
CROTALUS HORRIDUS HORRIDUS VENOMYHA2XLJ956ACTIB
IRONE1UOL152H7ACTIB
STRYCHNOS NUX-VOMICA SEED269XH13919ACTIB
PHOSPHORIC ACIDE4GA8884NNACTIB
PHOSPHORUS27YLU75U4WACTIB
SELENIUMH6241UJ22BACTIB
SEPIA OFFICINALIS JUICEQDL83WN8C2ACTIB
ZANTHOXYLUM AMERICANUM BARKA4KL1HMZ7TACTIB
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
STRESS / FATIGUEEPINEPHRINE, THYROID UNSPECIFIED,BOS TAURUS PITUITARY GLAND, ARSENIC TRIOXIDE, OYSTER SHELL CALCIUM CARBONATE CRUDE, CONIUM MACULATUM FLOWERING TOP, CORTISONE ACETATE, CROTALUS HORRIDUS HORRIDUS VENOM, IRON, STRYCHNOS NUX-VOMICA SEED, PHOSPHORIC ACID, PHOSPHORUS, SELENIUM, SEPIA OFFICINALIS JUICE, ZANTHOXYLUM AMERICANUM BARKNatural Creations, Inc.4c28ec7f-4490-4106-8472-d94c7073c3062022-03-03WarningsExact identifier
ndc (package): 43406-0612-1
ndc (product): 43406-0612
ndc11 (package): 43406061201
spl id: 2b02919f-d84a-4c9c-8b74-173ed40b2784
spl set id: 4c28ec7f-4490-4106-8472-d94c7073c306

Reported adverse events (FAERS/openFDA)#

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