ENL

Manufacturer
Jaymac Pharma | Viva Pharmaceuticals INC
Effective date
2025-10-14
Label type
MEDICAL FOOD
Version
6
Source
full-release
Hydrated at
2026-06-01 02:52:28

Label at a glance#

ProductENL
Active ingredientLEUCOVORIN, LEVOMEFOLATE MAGNESIUM, FERROUS CYSTEINE GLYCINATE, 1,2-DOCOSAHEXANOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, 1,2-ICOSAPENTOYL-SN-GLYCERO-3-PHOSPHOSERINE CALCIUM, PHOSPHATIDYL SERINE, PYRIDOXAL PHOSPHATE ANHYDROUS, FLAVIN ADENINE DINUCLEOTIDE, NADH, COBAMAMIDE, COCARBOXYLASE, MAGNESIUM ASCORBATE, ZINC ASCORBATE, MAGNESIUM L-THREONATE, BETAINE, CITRIC ACID MONOHYDRATE, SODIUM CITRATE
Label structure10 sections

Storage and handling

Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from heat, light and moisture. (Tamper Evident: Do not use if seal is broken or missing.) JAYMAC Pharmaceuticals, LLC, 2085 I-49 S. Service Rd, Sunset, LA 70584 MANUFACTURED AND/OR PACKAGED IN USA/CANADA ​Rev April 10, 2024 (V17)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

ENLTM

with reduced folates and adenosylcobalamin

[50 mg CBl] [15 mg DFE Folate]

​JAYMAC Pharmaceuticals, LLC

Softgels (30ct bottle)

Medical Food​ For Therapeutic Use

​Description

DESCRIPTION SECTION

ENLTMis a medical food for use under medical supervision to assist patients with MTHFR polymorphisms and other B-vitamin polymorphisms or “IEMs” in the clinical dietary management of depression or ADHD. It is specially formulated to meet the distinctive nutritional requirements of these patients and may be used alone or as an adjunct to standard therapy in the clinical dietary management of these conditions.

Each ENL TM capsule contains 15 mg DFE of reduced folates (from 7mg LevoMeFolic Acid [L-methylfolate Magnesium, CAS# 1429498-11-2] and ~3.5mg Levoleucovorin [Folinic Acid]) plus Adenosylcobalamin.

A recent study+ suggested that EnLyte® was effective in lowering homocysteine levels in patients that are positive for MTHFR (methylenetetrahydrofolate reductase polymorphism).

+ClinicalTrials.gov identifier: NCT02709668, Correlation of Clinical Response With Homocysteine Reduction During Therapy With Reduced B Vitamins in Patients with MDD Who Are Posititive for MTHFR C677T or A1298C Polymorphism.

INACTIVE INGREDIENT SECTION

INGREDIENTS: Olive oil, gelatin, magnesium ascorbate, Sharp-PS® Gold (phosphatidylserine-DHA complex), yellow beeswax, purified water, sodium citrate, l-methylfolate magnesium, sunflower lecithin, folinic acid, citric acid, annatto extract, elemental iron1 (from ferrous glycine cysteinate), zinc ascorbate, magnesium l-threonate, natural orange flavor, piperine, CoQ10 (ubidecarenone), betaine, vitamin B12 (adenosylcobalamin), FAD (flavin adenine dinucleotide), NADH (nicotinamide adenosine dinucleotide hydride), vitamin B6 (pyridoxal 5’ phosphate), vitamin B1 (thiamine pyrophosphate).

1 Pure amino acid, cysteinated iron chelate as AminoFerr® under exclusive license by Viva Pharmaceuticals, Canada, U.S. Patent #7341708.

CONTAINS FISH/KRILL/SOY. No artificial colorants. No dairy, wheat, sugar or egg.

INDICATION FOR USE:

INDICATIONS & USAGE SECTION

Clinical dietary management of Major Depressive Disorder or Attention-Deficit/Hyperactivity Disorder (ADHD) in patients with distinctive nutritional requirements related to impaired folate metabolism, such as those associated with MTHFR polymorphisms or other inborn errors of metabolism.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

Allergic reactions have been reported following the use of oral folate. Mild transient diarrhea, itching, transitory exanthema and the feeling of swelling of the entire body has been associated with Vitamin B12.

​PRECAUTIONS:

PRECAUTIONS SECTION

Folinic acid, when administered in daily doses above 0.1 mg, may obscure the detection of B12 deficiency specifically, the administration of folinic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological issues. Folate therapy alone is inadequate for the treatment of a B12 deficiency.

HOW SUPPLIED:

HOW SUPPLIED SECTION

ENL Bottle of 30 Product Code # 64661-082-25*. Each ENL reddish brown oval softgel is imprinted with “082”.

*JAYMAC does not represent these product codes to be National Drug Codes (NDC). Product codes are formatted according to standard industry practice, to meet the formatting requirements of pharmacy and health insurance computer systems.

​STORAGE:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°C to 30°C (59°F to 86°F) (See USP). Protect from heat, light and moisture.

(Tamper Evident: Do not use if seal is broken or missing.)

JAYMAC Pharmaceuticals, LLC, 2085 I-49 S. Service Rd, Sunset, LA 70584

MANUFACTURED AND/OR PACKAGED IN USA/CANADA

​Rev April 10, 2024 (V17)

label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ANHYDROUS CITRIC ACID Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
BETAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LEUCOVORIN Pharmacologic Class Indexing3Indexing - Pharmacologic Class20190712
LEVOMEFOLIC ACID Pharmacologic Class Indexing1Indexing - Pharmacologic Class20230428
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130364661082257GTIN-13: 0364661082257
EAN-13: 0364661082257
GTIN-12: 364661082257
UPC-A: 364661082257
GTIN storage (14 digits): 00364661082257
ENL Med Food Label V18 reduced (Oct 13 2025).jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
64661-082-25ENL30 in 1 BOTTLECAPSULE, LIQUID FILLED306

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
64661-08264661-082-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
52024-12-19full-release2026-06-01 02:51:19

Reported adverse events (FAERS/openFDA)#

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