MedPath

Red Delicious Apple

Allergenic Extract

Approved
Approval ID

9cf0d617-467d-461f-b6d3-d2d926982bb7

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Dec 9, 2009

Manufacturers
FDA

Nelco Laboratories, Inc.

DUNS: 054980867

Products 10

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

Orange Pekoe Tea

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1655
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Orange Pekoe Tea
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
TEA LEAFActive
Quantity: 0.05 g in 1 mL
Code: GH42T47V24
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

Hops

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1775
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hops
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

HOPSActive
Quantity: 0.05 g in 1 mL
Code: 01G73H6H83
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Black Pepper

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1767
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Black Pepper
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

BLACK PEPPERActive
Quantity: 0.05 g in 1 mL
Code: KM66971LVF
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

White Kidney Beans

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1759
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
White Kidney Beans
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

KIDNEY BEANActive
Quantity: 0.05 g in 1 mL
Code: M98C8416QO
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Vanilla

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1751
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Vanilla
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
VANILLAActive
Quantity: 0.05 g in 1 mL
Code: Q74T35078H
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT

Sesame

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1739
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sesame
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

SESAME SEEDActive
Quantity: 0.05 g in 1 mL
Code: 7Y1255HVXR
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Spearmint

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1743
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Spearmint
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SPEARMINTActive
Quantity: 0.05 g in 1 mL
Code: J7I2T6IV1N
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Sage

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1735
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Sage
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SALVIA OFFICINALISActive
Quantity: 0.05 g in 1 mL
Code: 065C5D077J
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Wheat Bran

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1755
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wheat Bran
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
WHEAT BRANActive
Quantity: 0.05 g in 1 mL
Code: 6L966A1IMR
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT

Peppermint

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code36987-1727
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Peppermint
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification

INGREDIENTS (6)

PEPPERMINT FLOWERING TOPActive
Quantity: 0.05 g in 1 mL
Code: V95R5KMY2B
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT

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