FDA.reportPublic FDA data

Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus

Product NDC
22840-0037
11-digit product format
228400037
Labeler code
22840
Product ID
22840-0037_2d7b99ba-afb8-40cd-e063-6294a90a789d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Dermatophagoides farinae and Dermatophagoides pteronyssinus
Dosage form
CONCENTRATE
Route
INTRADERMAL; PERCUTANEOUS; SUBCUTANEOUS
Labeler
Greer Laboratories, Inc.
Application
BLA101834
Marketing category
BLA
Marketing start
2010-02-03
Substance
DERMATOPHAGOIDES FARINAE; DERMATOPHAGOIDES PTERONYSSINUS
Active strength
5000; 5000 [AU]/mL; [AU]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Antigens, Dermatophagoides [CS], Antigens, Dermatophagoides [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Insect Proteins [CS], Insect Proteins [CS], Standardized Insect Allergenic Extract [EPC], Standardized Insect Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Standardized Mite Dermatophagoides farinaeDERMATOPHAGOIDES FARINAEGreer Laboratories, Inc.9b7f878e-613f-4831-9223-a6a07fb09f1b2025-02-06Boxed warning, Warnings, Adverse reactionsExact identifier
application number: BLA101834
ndc (product): 22840-0037

Additional Listing Data#

Finished product
Yes
Brand name base
Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DERMATOPHAGOIDES FARINAE5000 [AU]/mL
DERMATOPHAGOIDES PTERONYSSINUS5000 [AU]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
PR9U2YPF3QInternal UNII lookup
57L1Z5378KInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 7 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
852813Internal RxNorm lookup
852825Internal RxNorm lookup
852829Internal RxNorm lookup
854052Internal RxNorm lookup
854068Internal RxNorm lookup
1014384Internal RxNorm lookup
1192787Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
9b7f878e-613f-4831-9223-a6a07fb09f1bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
22840-0037-3Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus5 mL in 1 BOTTLE, DROPPERCONCENTRATE55
22840-0037-6Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus10 mL in 1 VIAL, MULTI-DOSECONCENTRATE105
22840-0037-9Standardized Mite Mix Dermatophagoides farinae and Dermatophagoides pteronyssinus50 mL in 1 VIAL, MULTI-DOSECONCENTRATE505

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Dermatophagoides farinaeACTIVE INGREDIENTPR9U2YPF3QALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE [GREER LABORATORIES, INC.]2
Dermatophagoides pteronyssinusACTIVE INGREDIENT57L1Z5378KALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE [GREER LABORATORIES, INC.]2
Dermatophagoides farinaeACTIVE MOIETYPR9U2YPF3QALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE [GREER LABORATORIES, INC.]2
Dermatophagoides pteronyssinusACTIVE MOIETY57L1Z5378KALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE ALLERGENIC EXTRACTS STANDARDIZED MITE (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE [GREER LABORATORIES, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
22840-0037STANDARDIZED MITE DERMATOPHAGOIDES PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE STANDARDIZED MITE DERMATOPHAGOIDES FARINAE (DERMATOPHAGOIDES FARINAE) CONCENTRATE STANDARDIZED MITE MIX DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS (DERMATOPHAGOIDES FARINAE AND DERMATOPHAGOIDES PTERONYSSINUS) CONCENTRATE [GREER LABORATORIES, INC.]5Current NDC, Legacy NDC, 3 package rows20250210_9b7f878e-613f-4831-9223-a6a07fb09f1b.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLAProprietary nameProper nameLicense typeStatusLatest source
101834Insects (Whole Body), Mite Dermatophagoides farinae351(a)Rx2026-06-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
852825American house dust mite extract 10000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
854052American house dust mite extract 30000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
852813American house dust mite extract 5000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
1192787Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
852829European house dust mite extract 10000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
854068European house dust mite extract 30000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
1014384European house dust mite extract 5000 AU/ML Injectable SolutionPSN9b7f878e-613f-4831-9223-a6a07fb09f1b5
852825American house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
854052American house dust mite allergenic extract 30000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
1192787American house dust mite allergenic extract 5000 AU/ML / European house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
852813American house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
852829European house dust mite allergenic extract 10000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
854068European house dust mite allergenic extract 30000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
1014384European house dust mite allergenic extract 5000 AU/ML Injectable SolutionSCD9b7f878e-613f-4831-9223-a6a07fb09f1b5
852825Dermatophagoides farinae extract 10,000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5
854052Dermatophagoides farinae extract 30,000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5
1192787Dermatophagoides farinae extract 5000 AU/ML / Dermatophagoides pteronyssinus extract 5000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5
852813Dermatophagoides farinae extract 5000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5
852829Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5
854068Dermatophagoides pteronyssinus extract 30,000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5
1014384Dermatophagoides pteronyssinus extract 5,000 AU/ML Injectable SolutionSY9b7f878e-613f-4831-9223-a6a07fb09f1b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
22840-0037-3228400037035 mL in 1 BOTTLE, DROPPER (22840-0037-3) 5 ml2010-02-030000-00-00NoNoCurrent
22840-0037-62284000370610 mL in 1 VIAL, MULTI-DOSE (22840-0037-6) 10 ml2010-02-030000-00-00NoNoCurrent
22840-0037-82284000370830 mL in 1 VIAL, MULTI-DOSE (22840-0037-8) 30 ml2010-02-030000-00-00NoNoCurrent
22840-0037-92284000370950 mL in 1 VIAL, MULTI-DOSE (22840-0037-9) 50 ml2010-02-030000-00-00NoNoCurrent