FDA.reportPublic FDA data

Cort Sym

Manufacturer
Energique, Inc. | Apotheca Company
Effective date
2024-10-24
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 02:28:27

Label at a glance#

ProductCort Sym
Active ingredientAPIS MELLIFERA, ATROPA BELLADONNA, OYSTER SHELL CALCIUM CARBONATE, CRUDE, DAPHNE MEZEREUM BARK, TOXICODENDRON PUBESCENS LEAF, ASTACUS ASTACUS, GELSEMIUM SEMPERVIRENS ROOT
Label structure9 sections

Dosage and administration

Apply topically to affected area 4 to 6 times daily.

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS:

OTC - ACTIVE INGREDIENT SECTION

(in gel): 4.29% of Apis Mellifica 12X, Astacus Fluviatilis 15X, Belladonna 12X, Calcarea Carbonica 12X, Gelsemium Sempervirens 15X, 

Mezereum 12X, Rhus Tox 12X.

INDICATIONS:

OTC - PURPOSE SECTION

May temporarily relieve itching, redness, and skin irritation due to rashes, eczema, insect bites, and other skin eruptions**

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

WARNINGS:

WARNINGS SECTION

For external use only. If an adverse reaction occurs, discontinue use.

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Do not use if tamper evident seal is broken or missing.

Store in a cool, dry place. Do not expose product to extreme temperatures.

KEEP OUT OF REACH OF CHILDREN:

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

DIRECTIONS:

DOSAGE & ADMINISTRATION SECTION

Apply topically to affected area 4 to 6 times daily.

INDICATIONS:

INDICATIONS & USAGE SECTION

May temporarily relieve itching, redness, and skin irritation due to rashes, eczema, insect bites, and other skin eruptions**

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

INACTIVE INGREDIENTS:

INACTIVE INGREDIENT SECTION

Water, Aloe Barbadensis Leaf Juice, Benzyl Alcohol, Ethylhexylglycerin, Tocopherol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Disodium EDTA, Sodium Hydroxide.

QUESTIONS:

OTC - QUESTIONS SECTION

Dist. by Energique, Inc., 201 Apple Blvd.

Woodbine, IA 51579       800.869.8078

PACKAGE LABEL DISPLAY:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ENERGIQUE
SINCE 1987
HOMEOPATHIC REMEDY
CORT SYM GEL
ANTI-ITCH
Net wt. 2 oz. (57 g)

Cort Sym GelCort Sym Gel

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
44911-0142-12024-10-24C16284748780-1ba0f9c33-5171-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0142-12024-01-30C16284748780-1ba0f9c33-5171-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0142-12022-04-18C16284748780-1ba0f9c33-5171-a910-e053-dadaa90a0b85DRUG FACTS:
44911-0142-12021-01-29C16284748780-1ba0f9c33-5171-a910-e053-dadaa90a0b85DRUG FACTS:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
44911-0142-1Cort Sym57 g in 1 TUBEGEL577

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
44911-0142CORT SYM (APIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, MEZEREUM, RHUS TOX, ASTACUS FLUVIATILIS, GELSEMIUM SEMPERVIRENS) GEL [ENERGIQUE, INC.]7Current NDC, Legacy NDC, 1 package rows20241027_8e9cd014-d0fa-4e8e-bd02-5b7bf27673ff.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
APIS MELLIFERAACTIVE INGREDIENT7S82P3R43Z2
ASTACUS ASTACUSACTIVE INGREDIENTV0551986XQ2
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H2
DAPHNE MEZEREUM BARKACTIVE INGREDIENTX2N6E405GV2
GELSEMIUM SEMPERVIRENS ROOTACTIVE INGREDIENT639KR60Q1Q2
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE INGREDIENT2E32821G6I2
TOXICODENDRON PUBESCENS LEAFACTIVE INGREDIENT6IO182RP7A2
APIS MELLIFERAACTIVE MOIETY7S82P3R43Z2
ASTACUS ASTACUSACTIVE MOIETYV0551986XQ2
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H2
DAPHNE MEZEREUM BARKACTIVE MOIETYX2N6E405GV2
GELSEMIUM SEMPERVIRENS ROOTACTIVE MOIETY639KR60Q1Q2
OYSTER SHELL CALCIUM CARBONATE, CRUDEACTIVE MOIETY2E32821G6I2
TOXICODENDRON PUBESCENS LEAFACTIVE MOIETY6IO182RP7A2
ALCOHOLINACTIVE INGREDIENT3K9958V90M2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995L2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH2
SODIUM HYDROXYMETHYLGLYCINATEINACTIVE INGREDIENTDIG6BWZ9XT2
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A22
TROMETHAMINEINACTIVE INGREDIENT023C2WHX2V2
WATERINACTIVE INGREDIENT059QF0KO0R2
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEE2

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44911-014244911-0142-1

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
APIS MELLIFERA7S82P3R43ZACTIB
ATROPA BELLADONNAWQZ3G9PF0HACTIB
OYSTER SHELL CALCIUM CARBONATE, CRUDE2E32821G6IACTIB
DAPHNE MEZEREUM BARKX2N6E405GVACTIB
TOXICODENDRON PUBESCENS LEAF6IO182RP7AACTIB
ASTACUS ASTACUSV0551986XQACTIB
GELSEMIUM SEMPERVIRENS ROOT639KR60Q1QACTIB
WATER059QF0KO0RIACT
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
BENZYL ALCOHOLLKG8494WBHIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
TOCOPHEROLR0ZB2556P8IACT
SODIUM HYDROXIDE55X04QC32IIACT
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT

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 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)71DD5V995LLOTION / TOPICAL21 mgExact identifier — unii+route
2 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TOPICAL500 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VGEL / TOPICAL56 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
SODIUM PYRROLIDONE CARBOXYLATESODIUM PYRROLIDONE CARBOXYLATE469OTG57A2LOTION / TOPICAL42 mgExact identifier — unii+route
2 equally ranked IID candidates
XANTHAN GUMXANTHAN GUMTTV12P4NEEGEL / TOPICAL58 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
TROMETHAMINETROMETHAMINE023C2WHX2VGEL / TOPICAL56 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ALCOHOLALCOHOL3K9958V90MGEL / TOPICAL9971 mgExact identifier — unii+route+dosage form
2 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
Cort SymAPIS MELLIFICA, BELLADONNA, CALCAREA CARBONICA, MEZEREUM, RHUS TOX, ASTACUS FLUVIATILIS, GELSEMIUM SEMPERVIRENSEnergique, Inc.8e9cd014-d0fa-4e8e-bd02-5b7bf27673ff2024-10-24WarningsExact identifier
ndc (package): 44911-0142-1
ndc (product): 44911-0142
ndc11 (package): 44911014201
spl id: cd8506b9-9276-4656-b0a9-2a1df1850bed
spl set id: 8e9cd014-d0fa-4e8e-bd02-5b7bf27673ff

Reported adverse events (FAERS/openFDA)#

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