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Dog Hair

Allergenic Extract

Approved
Approval ID

960c58a9-572e-41c5-8e0e-7ad1ff955030

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 20, 2009

Manufacturers
FDA

Antigen Laboratories, Inc.

DUNS: 030705628

Products 10

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

Guinea Pig Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0229
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Guinea Pig Hair
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
CAVIA PORCELLUS HAIRActive
Quantity: 0.1 g in 1 mL
Code: KBA5Y6X57N
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT

Goose Feather

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0225
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goose Feather
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ANSER ANSER FEATHERActive
Quantity: 0.05 g in 1 mL
Code: 15XI414745
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Rabbit Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0443
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Rabbit Hair
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
ORYCTOLAGUS CUNICULUS HAIRActive
Quantity: 0.1 g in 1 mL
Code: 09N62XQ70Y
Classification: ACTIB
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Feather Mixture

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0207
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Feather Mixture
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (7)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GALLUS GALLUS FEATHERActive
Quantity: 0.0167 g in 1 mL
Code: 1FCM16V0FV
Classification: ACTIB
ANAS PLATYRHYNCHOS FEATHERActive
Quantity: 0.0167 g in 1 mL
Code: 83B65P4796
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANSER ANSER FEATHERActive
Quantity: 0.0167 g in 1 mL
Code: 15XI414745
Classification: ACTIB

Goat Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0224
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Goat Hair
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
CAPRA HIRCUS HAIRActive
Quantity: 0.05 g in 1 mL
Code: 16M9MK8C4W
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Horse Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0257
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Horse Hair
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

EQUUS CABALLUS HAIRActive
Quantity: 0.02 g in 1 mL
Code: 4F35XG0149
Classification: ACTIB
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Duck Feather

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0167
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Duck Feather
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

WATERInactive
Code: 059QF0KO0R
Classification: IACT
ANAS PLATYRHYNCHOS FEATHERActive
Quantity: 0.05 g in 1 mL
Code: 83B65P4796
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT

Canary Feather

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0127
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Canary Feather
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
SERINUS CANARIA FEATHERActive
Quantity: 0.02 g in 1 mL
Code: 9EL3384IQY
Classification: ACTIB
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Dog Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0164
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Dog Hair
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

CANIS LUPUS FAMILIARIS HAIRActive
Quantity: 0.1 g in 1 mL
Code: 05S7L91ZTR
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Deer Hair

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code49288-0168
Application NumberBLA102223
Product Classification
M
Marketing Category
C73585
G
Generic Name
Deer Hair
Product Specifications
Route of AdministrationSUBCUTANEOUS, INTRADERMAL
Effective DateNovember 20, 2009
FDA Product Classification

INGREDIENTS (5)

GLYCERINInactive
Quantity: 0.525 mL in 1 mL
Code: PDC6A3C0OX
Classification: IACT
ODOCOILEUS VIRGINIANUS HAIRActive
Quantity: 0.05 g in 1 mL
Code: C27W02JU62
Classification: ACTIB
SODIUM CHLORIDEInactive
Quantity: 0.0095 g in 1 mL
Code: 451W47IQ8X
Classification: IACT
SODIUM BICARBONATEInactive
Quantity: 0.0024 g in 1 mL
Code: 8MDF5V39QO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT

Drug Labeling Information

BOXED WARNING SECTION

LOINC: 34066-1Updated: 11/20/2009

WARNINGS

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 11/20/2009

ADVERSE REACTIONS

Adverse reactions include, but are not limited to urticaria; itching; edema of extremities; respiratory wheezing or asthma; dyspnea; cyanosis; tachycardia; lacrimation; marked perspiration; flushing of face, neck or upper chest; mild persistent clearing of throat; hacking cough or persistent sneezing.

  1. Local Reactions

A mild burning immediately after injection is expected; this usually subsides in 10-20 seconds. Prolonged pain or pain radiating up arm is usually the result of intramuscular injection, making this injection route undesirable. Subcutaneous injection is the recommended route.

Small amounts of erythema and swelling at the site of injection are common. Reactions should not be considered significant unless they persist for at least 24 hours or exceed 50 mm in diameter.

Larger local reactions are not only uncomfortable, but indicate the possibility of a severe systemic reaction if dosage is increased. In such cases dosage should be reduced to the last level not causing reaction and maintained for two or three treatments before cautiously increasing.

Large, persistent local reactions or minor exacerbations of the patient’s allergic symptoms may be treated by local cold applications and/or use of oral antihistamines.

  1. Systemic Reactions

Systemic reactions range from mild exaggeration of patient’s allergic symptoms to anaphylactic reactions.14 Very sensitive patients may show a rapid response. It cannot be overemphasized that, under certain unpredictable combinations of circumstances, anaphylactic shock is always a possibility. Fatalities are rare but can occur.5 Other possible systemic reaction symptoms are fainting, pallor, bradycardia, hypotension, angioedema, cough, wheezing, conjunctivitis, rhinitis,and urticaria.13, 14

Careful attention to dosage and administration limit such reactions. Allergenic extracts are highly potent to sensitive individuals and OVERDOSE could result in anaphylactic symptoms. Therefore, it is imperative that physicians administering allergenic extracts understand and prepare for treatment of severe reactions. Refer to “OVERDOSAGE” section.

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