A-21

Product NDC
58264-0313
11-digit product format
582640313
Labeler code
58264
Product ID
58264-0313_2b50d137-37d8-851a-e063-6294a90a0a4d
Type
HUMAN OTC DRUG
Nonproprietary name
ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, COCHLIOBOLUS SATIVUS, CLADOSPORIUM BRUHNEI, MUCOR PLUMBEUS, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, and RHIZOPUS STOLONIFER
Dosage form
SOLUTION
Route
SUBLINGUAL
Labeler
DNA Labs, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
1990-01-01
Substance
ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; COCHLIOBOLUS SPICIFER; GIBBERELLA FUJIKUROI; COCHLIOBOLUS SATIVUS; CLADOSPORIUM BRUHNEI; MUCOR PLUMBEUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; RHIZOPUS STOLONIFER
Active strength
30; 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; [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], 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 · 10 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage58264-0313-186f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage58264-0313-1bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage58264-0313-18dfbde2a14a4…c9ff85d89658…
2020-12-18 03:04 UTC · source 2020-12-17excluded productproducte2bbac7714bc…27bdfed8d636…
2020-12-18 03:04 UTC · source 2020-12-17excluded packagepackage58264-0313-1e2bbac7714bc…27bdfed8d636…
2020-06-10 20:45 UTC · source 2020-06-10excluded productproduct9bebd1f3094a…5416666fcb17…
2020-06-10 20:45 UTC · source 2020-06-10excluded packagepackage58264-0313-19bebd1f3094a…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-21
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTERNARIA ALTERNATA30 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER30 [hp_X]/mL
COCHLIOBOLUS SPICIFER30 [hp_X]/mL
GIBBERELLA FUJIKUROI30 [hp_X]/mL
COCHLIOBOLUS SATIVUS30 [hp_X]/mL
CLADOSPORIUM BRUHNEI30 [hp_X]/mL
MUCOR PLUMBEUS30 [hp_X]/mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM30 [hp_X]/mL
AUREOBASIDIUM PULLULANS VAR. PULLUTANS30 [hp_X]/mL
RHIZOPUS STOLONIFER30 [hp_X]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 10 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
52B29REC7HInternal UNII lookup
9IOA40ANG6Internal UNII lookup
91M9RWP3TDInternal UNII lookup
815V716OR2Internal UNII lookup
3LN5B70U4WInternal UNII lookup
R1786Y8H66Internal UNII lookup
D7401PWY6EInternal UNII lookup
3Y1PE1GCIGInternal UNII lookup
D1A2NG69CKInternal UNII lookup
FEE198DK4QInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
601195dd-1e5b-47e9-9611-06d3eb2b8dc6Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58264-0313-12022-05-30C16284748780-19d75b9d0-247c-f424-e053-dadaa90a57ceA-21
58264-0313-12020-01-31C16284748780-19d75b9d0-247c-f424-e053-dadaa90a57ceA-21

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58264-0313-1A-2129.57 mL in 1 BOTTLE, GLASSSOLUTION29.573

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58264-0313A-21 (ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, COCHLIOBOLUS SATIVUS, CLADOSPORIUM BRUHNEI, MUCOR PLUMBEUS, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, AND RHIZOPUS STOLONIFER) SOLUTION [DNA LABS, INC.]3Current NDC, Legacy NDC, 1 package rows20250112_601195dd-1e5b-47e9-9611-06d3eb2b8dc6.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-21ALTERNARIA ALTERNATA, ASPERGILLUS NIGER VAR. NIGER, COCHLIOBOLUS SPICIFER, GIBBERELLA FUJIKUROI, COCHLIOBOLUS SATIVUS, CLADOSPORIUM BRUHNEI, MUCOR PLUMBEUS, PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM, AUREOBASIDIUM PULLULANS VAR. PULLUTANS, AND RHIZOPUS STOLONIFERDNA Labs, Inc.601195dd-1e5b-47e9-9611-06d3eb2b8dc62025-01-09WarningsExact identifier
ndc (product): 58264-0313

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58264-0313-15826403130129.57 mL in 1 BOTTLE, GLASS (58264-0313-1) 29.57 ml1990-01-010000-00-00NoNoCurrent