MedPath

Lolleez Variety Pack

BFY LLC

Approved
Approval ID

f561685a-5260-59c6-e053-2a95a90ae206

Product Type

HUMAN OTC DRUG LABEL

Effective Date

May 7, 2025

Manufacturers
FDA

BFY LLC

DUNS: 080651312

Products 10

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

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-4014
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

PECTINActive
Quantity: 11.5 mg in 3.5 g
Code: 89NA02M4RX
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-4615
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

SUCROSEInactive
Code: C151H8M554
Classification: IACT
PECTINActive
Quantity: 11.5 mg in 7 g
Code: 89NA02M4RX
Classification: ACTIB

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-4114
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

PECTINActive
Quantity: 11.5 mg in 3.5 g
Code: 89NA02M4RX
Classification: ACTIB
SUCROSEInactive
Code: C151H8M554
Classification: IACT

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-4314
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

PECTINActive
Quantity: 11.5 mg in 3.5 g
Code: 89NA02M4RX
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-3495
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PECTINActive
Quantity: 11.5 mg in 7 g
Code: 89NA02M4RX
Classification: ACTIB

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-3395
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT
PECTINActive
Quantity: 11.5 mg in 7 g
Code: 89NA02M4RX
Classification: ACTIB

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-3295
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

PECTINActive
Quantity: 11.5 mg in 7 g
Code: 89NA02M4RX
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Pectin

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-4540
Application NumberM022
Product Classification
M
Marketing Category
C200263
G
Generic Name
Pectin
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

PECTINActive
Quantity: 11.5 mg in 7 g
Code: 89NA02M4RX
Classification: ACTIB
CITRIC ACID MONOHYDRATEInactive
Code: 2968PHW8QP
Classification: IACT

Calcium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-6010
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

CALCIUM CARBONATEActive
Quantity: 200 mg in 7 g
Code: H0G9379FGK
Classification: ACTIB
HONEYInactive
Code: Y9H1V576FH
Classification: IACT

Calcium Carbonate

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code72427-2001
Application NumberM001
Product Classification
M
Marketing Category
C200263
G
Generic Name
Calcium Carbonate
Product Specifications
Route of AdministrationORAL
Effective DateMay 7, 2025
FDA Product Classification

INGREDIENTS (2)

HONEYInactive
Code: Y9H1V576FH
Classification: IACT
CALCIUM CARBONATEActive
Quantity: 200 mg in 7 g
Code: H0G9379FGK
Classification: ACTIB

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Lolleez Variety Pack - FDA Drug Approval Details