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; AUREOBASIDIUM PULLULANS VAR. PULLUTANS; CLADOSPORIUM BRUHNEI; COCHLIOBOLUS SATIVUS; COCHLIOBOLUS SPICIFER; GIBBERELLA FUJIKUROI; MUCOR PLUMBEUS; PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM; 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

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
AUREOBASIDIUM PULLULANS VAR. PULLUTANS30 [hp_X]/mL
CLADOSPORIUM BRUHNEI30 [hp_X]/mL
COCHLIOBOLUS SATIVUS30 [hp_X]/mL
COCHLIOBOLUS SPICIFER30 [hp_X]/mL
GIBBERELLA FUJIKUROI30 [hp_X]/mL
MUCOR PLUMBEUS30 [hp_X]/mL
PENICILLIUM CHRYSOGENUM VAR. CHRYSOGENUM30 [hp_X]/mL
RHIZOPUS STOLONIFER30 [hp_X]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii52B29REC7H, 9IOA40ANG6, D1A2NG69CK, R1786Y8H66, 3LN5B70U4W, 91M9RWP3TD, 815V716OR2, D7401PWY6E, 3Y1PE1GCIG, FEE198DK4Q

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

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