Red Delicious Apple
Allergenic Extract
Approved
Approval ID
42a03973-e3db-49f2-9264-f76aa831c045
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.
Hops
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1777
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: 0.1 g in 1 mL
Code: 01G73H6H83
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Orange Pekoe Tea
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1657
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)
TEA LEAFActive
Quantity: 0.1 g in 1 mL
Code: GH42T47V24
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
White Pepper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1725
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
White Pepper
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (6)
WHITE PEPPERActive
Quantity: 0.1 g in 1 mL
Code: M29DW54Q9E
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
Sage
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1737
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 BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SALVIA OFFICINALISActive
Quantity: 0.1 g in 1 mL
Code: 065C5D077J
Classification: ACTIB
Peppermint
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1729
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)
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
PEPPERMINT FLOWERING TOPActive
Quantity: 0.1 g in 1 mL
Code: V95R5KMY2B
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
White Kidney Beans
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1761
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: 0.1 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
Black Pepper
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1769
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: 0.1 g in 1 mL
Code: KM66971LVF
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 Code36987-1745
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)
SPEARMINTActive
Quantity: 0.1 g in 1 mL
Code: J7I2T6IV1N
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Poppyseed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1733
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Poppyseed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
POPPY SEEDActive
Quantity: 0.1 g in 1 mL
Code: 60RO23IR87
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Thym
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-1749
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Thym
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 9, 2009
FDA Product Classification
INGREDIENTS (6)
GARDEN THYMEActive
Quantity: 0.1 g in 1 mL
Code: CW657OBU4N
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT