A-22

Product NDC
58264-0314
Requested package NDC
58264-0314-1
11-digit product format
582640314
Labeler code
58264
Product ID
58264-0314_2b50d0ac-9542-eba3-e063-6394a90ade3d
Type
HUMAN OTC DRUG
Nonproprietary name
ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, and PENICILLIUM ROQUEFORTI
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ASPERGILLUS FLAVUS; ASPERGILLUS FUMIGATUS; EUROTIUM HERBARIORUM; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; PENICILLIUM CAMEMBERTI; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; PENICILLIUM DIGITATUM; PENICILLIUM ROQUEFORTI
Active strength
30; 30; 30; 30; 30; 30; 30; 30; 30 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL
Pharmacologic classes
Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Allergens [CS], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Fungal Proteins [CS], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased Histamine Release [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC], Non-Standardized Fungal Allergenic Extract [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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 1 · 5 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-278dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-109bebd1f3094a…5416666fcb17…

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
A-22
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASPERGILLUS FLAVUS30 [hp_X]/mL
ASPERGILLUS FUMIGATUS30 [hp_X]/mL
EUROTIUM HERBARIORUM30 [hp_X]/mL
ASPERGILLUS NIDULANS30 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER30 [hp_X]/mL
PENICILLIUM CAMEMBERTI30 [hp_X]/mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM30 [hp_X]/mL
PENICILLIUM DIGITATUM30 [hp_X]/mL
PENICILLIUM ROQUEFORTI30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 9 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3J888Y9L13Internal UNII lookup
X88DF51T48Internal UNII lookup
49W168AES4Internal UNII lookup
242A53RB80Internal UNII lookup
9IOA40ANG6Internal UNII lookup
T069R9OPVGInternal UNII lookup
3Y1PE1GCIGInternal UNII lookup
1SB49SV239Internal UNII lookup
7ORP6R724LInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b8a80814-603c-4941-bc2d-4f3d888769a6Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0314-12022-05-30C16284748780-19d75b9cf-f8f9-f424-e053-dadaa90a57ceA-22
58264-0314-12020-01-31C16284748780-19d75b9cf-f8f9-f424-e053-dadaa90a57ceA-22

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0314-1A-2229.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0314A-22 (ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, AND PENICILLIUM ROQUEFORTI) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_b8a80814-603c-4941-bc2d-4f3d888769a6.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

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

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
A-22ASPERGILLUS FLAVUS, ASPERGILLUS FUMIGATUS, EUROTIUM HERBARIORUM, ASPERGILLUS NIDULANS, ASPERGILLUS NIGER VAR. NIGER, PENICILLIUM CAMEMBERTI, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, PENICILLIUM DIGITATUM, AND PENICILLIUM ROQUEFORTIDNA Labs, Inc.b8a80814-603c-4941-bc2d-4f3d888769a62025-01-09WarningsExact identifier
ndc (package): 58264-0314-1
ndc (product): 58264-0314
ndc11 (package): 58264031401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0314-15826403140129.57 mL in 1 BOTTLE, GLASS (58264-0314-1) 29.57 ml1990-01-010000-00-00NoNoCurrent