FDA.reportPublic FDA data

FCS HP

Manufacturer
Natural Creations, Inc. | OHM Pharma, Inc.
Effective date
2016-08-02
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:08:06

Label at a glance#

ProductFCS HP
Active ingredientEPINEPHRINE, GLUTAMIC ACID, MUCUNA PRURIENS SEED, NIACINAMIDE, SEROTONIN, UBIDECARENONE, CORTICOTROPIN, ASCORBIC ACID, ADENOSINE TRIPHOSPHATE, INSULIN PORK, SUS SCROFA PARATHYROID GLAND, SUS SCROFA PITUITARY GLAND, THIAMINE HYDROCHLORIDE, THYROID, UNSPECIFIED, ANHYDROUS CITRIC ACID, HERRING SPERM DNA, SACCHAROMYCES CEREVISIAE RNA, ANACARDIUM OCCIDENTALE FRUIT, ARSENIC TRIOXIDE, ASPARTIC ACID, BARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE, CRUDE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, DATURA STRAMONIUM, SULFUR
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS - equal amounts of: Adrenalinum 8X, 12X, 30X, 6C, 12C, 30C,  L-Glutamic Acid 8X, 12X, 30X, 12C, 30C, Mucuna Pruriens 8X, 12X, 30X, 12C, 30C, Niacinamide 8X, Serotonin 8X, 12X, 30X, 12C, 30C, Ubiquinone 8X, ACTH 8X, 12X, 30X, 12C, 30C, Ascorbic Acid 6C, ATP 6C, Insulinum 6C, Parathyroidinum 6C, Pituitaria Glandula 6C, Thiaminum Hydrochloricum 6C, Thyroidinum 6C, Citricum Ac 12C, DNA 12C, RNA 12C, Anacardium Occ 30C, Arsenicum Alb 30C, Aspartic Acid 30C, Baryta Carb 30C, Calc Carb 30C, Lycopodium 30C, Pulsatilla 30C, Stramonium 30C, Sulphur 30C.

OTC - PURPOSE SECTION

Uses: Helps restore mental alertness.**

INDICATIONS & USAGE SECTION

Uses: Helps restore mental alertness.**

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

** These statements have not been reviewed by the FDA. They are based on traditional homeopathic practice.

LOT:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43406–0617-1

FCS HP

Mental Alertness**

HOMEOPATHIC

1 fl oz (30 mL) / 20% Alcohol

GMP Logo UPC: 877730004536 NON GMO Logo

image descriptionimage description

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130877730004536GTIN-13: 0877730004536
EAN-13: 0877730004536
GTIN-12: 877730004536
UPC-A: 877730004536
GTIN storage (14 digits): 00877730004536		FCSHP.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0b4ec9ca-d305-43fc-88dd-7a510313efe0Product name120260105
bb209f42-a85f-4fee-9d3d-c9dded168625Product name120251208
49628fc7-2031-4c28-bd31-0ef3aa8f44a3Product name320251118
cbf85893-59ef-423f-87d4-a573c000a8b9Product name820250731
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
b5b1095b-40cd-8a9e-b111-502545045b07Product name420250325
e190029e-423b-473c-8e04-2ada59b5b711Product name120250314
7314d8f7-fa99-4dc2-9f68-de2ff142f4b7Product name220250121
63f39a63-5cd1-4016-bd86-2bbb0f6c3139Product name320240506
e5a77e9c-c528-733a-173d-914a234c024bProduct name520240506
e0031c74-3853-42bc-8e10-86dbbe83992eProduct name220231116
f7046b89-2016-499a-adc6-78479172abc6Product name120230425
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43406-0617-12020-01-31C16284748780-19d75b9d1-1d37-f424-e053-dadaa90a57ceFCS HP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43406-0617-1FCS HP30 mL in 1 BOTTLE, DROPPERLIQUID301

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43406-0617FCS HP (EPINEPHRINE, GLUTAMIC ACID, MUCUNA PRURIENS SEED, NIACINAMIDE, SEROTONIN, UBIDECARENONE, CORTICOTROPIN, ASCORBIC ACID, ADENOSINE TRIPHOSPHATE, INSULIN PORK, SUS SCROFA PARATHYROID GLAND, SUS SCROFA PITUITARY GLAND, THIAMINE HYDROCHLORIDE, THYROID, ANHYDROUS CITRIC ACID, HERRING SPERM DNA, SACCHAROMYCES CEREVISIAE RNA, ANACARDIUM OCCIDENTALE FRUIT, ARSENIC TRIOXIDE, ASPARTIC ACID, BARIUM CARBONATE, OYSTER SHELL CALCIUM CARBONATE CRUDE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PULSATILLA, DATURA STRAMONIUM, SULFUR) LIQUID [NATURAL CREATIONS, INC.]1Legacy NDC, 1 package rows20160802_d612a284-b301-40a9-a94d-222697637a44.zip

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43406-061743406-0617-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
EPINEPHRINEYKH834O4BHACTIB
GLUTAMIC ACID3KX376GY7LACTIB
MUCUNA PRURIENS SEED55G8SQ543SACTIB
NIACINAMIDE25X51I8RD4ACTIB
SEROTONIN333DO1RDJYACTIB
UBIDECARENONEEJ27X76M46ACTIB
CORTICOTROPINK0U68Q2TXAACTIB
ASCORBIC ACIDPQ6CK8PD0RACTIB
ADENOSINE TRIPHOSPHATE8L70Q75FXEACTIB
INSULIN PORKAVT680JB39ACTIB
SUS SCROFA PARATHYROID GLAND2KBE35NE8SACTIB
SUS SCROFA PITUITARY GLANDE8S87O660TACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIB
THYROID, UNSPECIFIED0B4FDL9I6PACTIB
ANHYDROUS CITRIC ACIDXF417D3PSLACTIB
HERRING SPERM DNA51FI676N6FACTIB
SACCHAROMYCES CEREVISIAE RNAJ17GBZ5VGXACTIB
ANACARDIUM OCCIDENTALE FRUIT4A10JR4E7EACTIB
ARSENIC TRIOXIDES7V92P67HOACTIB
ASPARTIC ACID30KYC7MIAIACTIB
BARIUM CARBONATE6P669D8HQ8ACTIM
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
LYCOPODIUM CLAVATUM SPOREC88X29Y479ACTIB
ANEMONE PULSATILLAI76KB35JEVACTIB
DATURA STRAMONIUMG6W4F0V8Z3ACTIB
SULFUR70FD1KFU70ACTIB
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
3331bc2f-9327-4614-af72-73ebdc415de8d612a284-b301-40a9-a94d-222697637a442016-08-02WarningsExact identifier
spl id: 3331bc2f-9327-4614-af72-73ebdc415de8
spl set id: d612a284-b301-40a9-a94d-222697637a44

Reported adverse events (FAERS/openFDA)#

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