Myco Sode

Product NDC
83027-0068
11-digit product format
830270068
Labeler code
83027
Product ID
83027-0068_98817207-be37-45cb-845f-37be383e9ab8
Type
HUMAN OTC DRUG
Nonproprietary name
Alternaria Tenuis Nees, Aspergillus Niger, Candida Albicans, Candida Parapsilosis, Mucor Racemosus, Candida Krusei, Rhizopus Nigricans, Candida Tropicalis
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-04-27
Marketing end
2028-05-19
Substance
ALTERNARIA ALTERNATA; ASPERGILLUS NIGER VAR. NIGER; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CANDIDA TROPICALIS; ISSATCHENKIA ORIENTALIS WHOLE; MUCOR RACEMOSUS; RHIZOPUS STOLONIFER
Active strength
16; 16; 16; 16; 32; 16; 16; 16 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL
Pharmacologic classes
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], 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 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]
NDC exclude flag
No
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Myco Sode

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ALTERNARIA ALTERNATA16 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER16 [hp_X]/mL
CANDIDA ALBICANS16 [hp_X]/mL
CANDIDA PARAPSILOSIS16 [hp_X]/mL
CANDIDA TROPICALIS32 [hp_C]/mL
ISSATCHENKIA ORIENTALIS WHOLE16 [hp_C]/mL
MUCOR RACEMOSUS16 [hp_X]/mL
RHIZOPUS STOLONIFER16 [hp_C]/mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii52B29REC7H, 9IOA40ANG6, 4D7G21HDBC, 0KZ676D44N, Q222J2186W, 138TJ2U1SD, 17RH99LQ7G, FEE198DK4Q

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0068-1Myco Sode60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0068MYCO SODE (ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, MUCOR RACEMOSUS, CANDIDA KRUSEI, RHIZOPUS NIGRICANS, CANDIDA TROPICALIS) SPRAY [NUTRITIONAL SPECIALTIES, INC.]2Current NDC, 1 package rows20240913_4dbbd970-f3ad-4d96-9b54-7aa2c8323be2.zip

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83027-0068-18302700680160 mL in 1 BOTTLE, SPRAY (83027-0068-1) 60 ml2023-04-272028-05-19NoNoHistorical