A-22

Product NDC
58264-0314
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; ASPERGILLUS NIDULANS; ASPERGILLUS NIGER VAR. NIGER; EUROTIUM HERBARIORUM; 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

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
ASPERGILLUS NIDULANS30 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER30 [hp_X]/mL
EUROTIUM HERBARIORUM30 [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 Identifiers#

Field, Values table
FieldValues
Unii3J888Y9L13, X88DF51T48, 242A53RB80, 9IOA40ANG6, 49W168AES4, T069R9OPVG, 3Y1PE1GCIG, 1SB49SV239, 7ORP6R724L

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

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