Dandelion
Allergenic Extract
Approved
Approval ID
7f312e04-f414-4f1e-bce2-ea43fe3d93f9
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 4, 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.
Carelessweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3160
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Carelessweed
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
AMARANTHUS PALMERI POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 1GH3WV23KH
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Wormwook
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3448
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Wormwook
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
ARTEMISIA ABSINTHIUM POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 81GS97HVFO
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Curly Dock
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3184
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Curly Dock
Product Specifications
Route of AdministrationINTRADERMAL, SUBCUTANEOUS
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
RUMEX CRISPUS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: V825XJG64G
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
Hackberry
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3352
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Hackberry
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
CELTIS OCCIDENTALIS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 68R9X9Y96X
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Russian Thistle
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3400
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Russian Thistle
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
SALSOLA KALI POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 2MH135KC6G
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
Ailanthus
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3360
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Ailanthus
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
AILANTHUS ALTISSIMA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 2A64U81OQ3
Classification: ACTIB
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
False Ragweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3368
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
False Ragweed
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
AMBROSIA ACANTHICARPA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: U2AI3H2J5Y
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
Greasewood
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3376
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Greasewood
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
SARCOBATUS VERMICULATUS POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: 6532U64A3X
Classification: ACTIB
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Common Sagebrush
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3408
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Common Sagebrush
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
SODIUM CHLORIDEInactive
Code: 451W47IQ8X
Classification: IACT
PHENOLInactive
Code: 339NCG44TV
Classification: IACT
ARTEMISIA TRIDENTATA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: YI19RB8YFD
Classification: ACTIB
SODIUM BICARBONATEInactive
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
Western Ragweed
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code36987-3432
Application NumberBLA102192
Product Classification
M
Marketing Category
C73585
G
Generic Name
Western Ragweed
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateDecember 4, 2009
FDA Product Classification
INGREDIENTS (6)
AMBROSIA PSILOSTACHYA POLLENActive
Quantity: 20000 [PNU] in 1 mL
Code: RX18M46K8L
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