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EnLyte Gummy plus

EnLyte Gummy+

Approved
Approval ID

b53f97ca-036d-4000-b16a-99dd9f5bb138

Product Type

DIETARY SUPPLEMENT

Effective Date

Sep 18, 2025

Manufacturers
FDA

Jaymac Pharmaceutical

DUNS: 830767260

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Multivitamin/Multimineral Supplement

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code64661-222
Product Classification
G
Generic Name
Multivitamin/Multimineral Supplement
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 18, 2025
FDA Product Classification

INGREDIENTS (20)

LEVOMEFOLATE MAGNESIUMActive
Quantity: 1 mg in 1 1
Code: 1VZZ62R081
Classification: ACTIB
LEUCOVORINActive
Quantity: 1 mg in 1 1
Code: Q573I9DVLP
Classification: ACTIB
METHYLCOBALAMINActive
Quantity: 16.7 ug in 1 1
Code: BR1SN1JS2W
Classification: ACTIB
ZINC CITRATEActive
Quantity: 6.7 mg in 1 1
Code: K72I3DEX9B
Classification: ACTIM
MAGNESIUM CITRATEActive
Quantity: 16.7 mg in 1 1
Code: RHO26O1T9V
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 16.7 ug in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
THIAMINE HCLActive
Quantity: 8.3 ug in 1 1
Code: M572600E5P
Classification: ACTIB
RIBOFLAVINActive
Quantity: 8.3 ug in 1 1
Code: TLM2976OFR
Classification: ACTIB
PHOSPHATIDYLSERINEActive
Quantity: 25 mg in 1 1
Code: 394XK0IH40
Classification: ACTIB
NICOTINAMIDE ADENINE DINUCLEOTIDEActive
Quantity: 8.3 ug in 1 1
Code: 0U46U6E8UK
Classification: ACTIB
DOCOSAHEXAENOIC ACID ALGAL OILActive
Quantity: 2.7 mg in 1 1
Code: QGK4EZ8JB9
Classification: ACTIB
GLUCOSEInactive
Code: 5SL0G7R0OK
Classification: IACT
SUCROSEInactive
Code: C151H8M554
Classification: IACT
AGARInactive
Code: 89T13OHQ2B
Classification: IACT
LOCUST BEAN GUMInactive
Code: V4716MY704
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
MALIC ACIDInactive
Code: 817L1N4CKP
Classification: IACT
CITRIC ACIDInactive
Code: 2968PHW8QP
Classification: IACT
STRAWBERRYInactive
Code: 4J2TY8Y81V
Classification: IACT
BUGLOSSOIDES ARVENSIS WHOLEInactive
Code: 2AEA0I5JKQ
Classification: IACT

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/9/2025

image description

Statement of Identity section

LOINC: 69718-5Updated: 9/8/2025

DIETARY SUPPLEMENT

HEALTH CLAIM SECTION

LOINC: 69719-3Updated: 9/8/2025

DESCRIPTION:

EnLyte® Gummy+ is a prescription multivitamin/multimineral supplement specially formulated with active folates, vitamin B12, and omega-3s to support brain health, methylation, emotional well-being, focus, and overall mental wellness.*

Free of major allergens: SOY, GLUTEN, DAIRY, EGGS, PEANUTS, TREE NUTS, SESAME & SHELLFISH.

No artificial colors, artificial flavor, gelatin.

NON-GMO (genetically modified organism).

KOSHER & HALAL

Ahiflower oil naturally improves the circulating levels of EPA.

*These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any diseases.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/4/2025

DIRECTIONS:

Kids 2 to 8 years take 1 gummy or as directed by a healthcare provider. May be taken with or without food.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 9/8/2025

PRECAUTIONS:

Folate doses above 0.1 mg per day may mask vitamin B12 deficiency by improving hematological symptoms, such as those seen in pernicious anemia, without addressing neurological complications. L-methylfolate is believed to have a lower risk of masking B12 deficiency than folic acid. Folate therapy alone is inadequate for the treatment of a vitamin B12 deficiency.

ADVERSE REACTIONS:

Allergic reactions have been reported with oral folate supplementation. Mild, transient diarrhea, itching, rash (exanthema), and generalized swelling have been associated with vitamin B12 use

HOW SUPPLIED:

EnLyte®Gummy+ Bottle of 30 - Product Code # 64661-220-30. EnLyte®Gummy+ is a round, maroon gummy.

SAFE HANDLING WARNING SECTION

LOINC: 50741-8Updated: 9/8/2025

STORAGE:

Store at controlled room temperature 15°C to 30°C (59°F to 86°F). Protect from heat, light, and moisture. (Tamper Evident: Do not use if seal is broken or missing.)

WARNINGS SECTION

LOINC: 34071-1Updated: 9/8/2025

WARNING:

KEEP THIS OUT OF THE REACH OF CHILDREN.

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EnLyte Gummy plus - FDA Drug Approval Details