STANDARDIZED MITE D FARINAE

Product NDC: 54575-325
11-digit product format: 545750325
Labeler code: 54575
Product ID: 54575-325_27179a6a-453e-4e7d-8115-f98dcfcf3ec5
Type: STANDARDIZED ALLERGENIC
Nonproprietary name: Dermatophagoides farinae
Dosage form: INJECTION, SOLUTION
Route: PERCUTANEOUS; SUBCUTANEOUS
Labeler: Allergy Laboratories, Inc.
Application: BLA101377
Marketing category: BLA
Marketing start: 1989-01-25
Marketing end: 0000-00-00
Substance: DERMATOPHAGOIDES FARINAE
Active strength: 10000 [AU]/mL
Pharmacologic classes: Allergens [CS],Insect Proteins [CS],Standardized Insect Allergenic Extract [EPC],Increased Histamine Release [PE],Cell-mediated Immunity [PE],Increased IgG Production [PE],Antigens, Dermatophagoides [CS]
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54575-325		D	Discontinued by firm	2026-10-05
excluded package	package	54575-325	54575-325-02	D	Discontinued by firm	2026-10-05
excluded package	package	54575-325	54575-325-10	D	Discontinued by firm	2026-10-05
excluded package	package	54575-325	54575-325-30	D	Discontinued by firm	2026-10-05
excluded package	package	54575-325	54575-325-50	D	Discontinued by firm	2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 2 · 95 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54575-325-30	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54575-325-10	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54575-325-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54575-325-50	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54575-325-30	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54575-325-10	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54575-325-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54575-325-50	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54575-325-30	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54575-325-10	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54575-325-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54575-325-50	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54575-325-30	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54575-325-10	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54575-325-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54575-325-50	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54575-325-30	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54575-325-10	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54575-325-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54575-325-50	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54575-325-30	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54575-325-10	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54575-325-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54575-325-50	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54575-325-30	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54575-325-10	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54575-325-02	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54575-325-50	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54575-325-30	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54575-325-10	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54575-325-02	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54575-325-50	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54575-325-30	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54575-325-10	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54575-325-02	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54575-325-50	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54575-325-30	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54575-325-10	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54575-325-02	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54575-325-50	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54575-325-30	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54575-325-10	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54575-325-02	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54575-325-50	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54575-325-30	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54575-325-10	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54575-325-02	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54575-325-50	`557ba5c1ecfa…`	`9c80585c8c6e…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
54575-325-02	Standardized Mites
54575-325-10	Standardized Mites
54575-325-30	Standardized Mites
54575-325-50	Standardized Mites

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
54575-325-02	STANDARDIZED MITE D FARINAE	2 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	2	7
54575-325-10	STANDARDIZED MITE D FARINAE	10 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	10	7
54575-325-30	STANDARDIZED MITE D FARINAE	30 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	30	7
54575-325-50	STANDARDIZED MITE D FARINAE	50 mL in 1 VIAL, MULTI-DOSE	INJECTION, SOLUTION	50	7

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DERMATOPHAGOIDES FARINAE	ACTIVE INGREDIENT	PR9U2YPF3Q	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
DERMATOPHAGOIDES PTERONYSSINUS	ACTIVE INGREDIENT	57L1Z5378K	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
DERMATOPHAGOIDES FARINAE	ACTIVE MOIETY	PR9U2YPF3Q	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
DERMATOPHAGOIDES PTERONYSSINUS	ACTIVE MOIETY	57L1Z5378K	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
SODIUM BICARBONATE	INACTIVE INGREDIENT	8MDF5V39QO	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5
WATER	INACTIVE INGREDIENT	059QF0KO0R	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54575-325	STANDARDIZED MITE D FARINAE (DERMATOPHAGOIDES FARINAE) INJECTION, SOLUTION STANDARDIZED MITE D PTERONYSSINUS (DERMATOPHAGOIDES PTERONYSSINUS) INJECTION, SOLUTION [ALLERGY LABORATORIES, INC.]	7	Legacy NDC, 4 package rows	20170807_073f4c55-7bc3-4dd1-ae93-74f500cd912e.zip

Purple Book Biologic Products#

BLA, Proprietary name, Proper name table
BLA	Proprietary name	Proper name	License type	Status	Latest source
101377		Insects (Whole Body), Mite Dermatophagoides farinae	351(a)	Disc	2026-09-01

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
PR9U2YPF3Q	DERMATOPHAGOIDES FARINAE	DERMATOPHAGOIDES FARINAE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
852825	American house dust mite extract 10000 AU/ML Injectable Solution	PSN	073f4c55-7bc3-4dd1-ae93-74f500cd912e	7
852829	European house dust mite extract 10000 AU/ML Injectable Solution	PSN	073f4c55-7bc3-4dd1-ae93-74f500cd912e	7
852825	American house dust mite allergenic extract 10000 AU/ML Injectable Solution	SCD	073f4c55-7bc3-4dd1-ae93-74f500cd912e	7
852829	European house dust mite allergenic extract 10000 AU/ML Injectable Solution	SCD	073f4c55-7bc3-4dd1-ae93-74f500cd912e	7
852825	Dermatophagoides farinae extract 10,000 AU/ML Injectable Solution	SY	073f4c55-7bc3-4dd1-ae93-74f500cd912e	7
852829	Dermatophagoides pteronyssinus extract 10,000 AU/ML Injectable Solution	SY	073f4c55-7bc3-4dd1-ae93-74f500cd912e	7

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54575-325-02	54575032502	2 mL in 1 VIAL, MULTI-DOSE	2 ml	Historical
54575-325-10	54575032510	10 mL in 1 VIAL, MULTI-DOSE	10 ml	Historical
54575-325-30	54575032530	30 mL in 1 VIAL, MULTI-DOSE	30 ml	Historical
54575-325-50	54575032550	50 mL in 1 VIAL, MULTI-DOSE	50 ml	Historical