Home NDC 83027-0068 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; MUCOR RACEMOSUS; ISSATCHENKIA ORIENTALIS WHOLE; RHIZOPUS STOLONIFER; CANDIDA TROPICALIS
Active strength 16; 16; 16; 16; 16; 16; 16; 32 [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/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 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 Myco Sode Active Ingredients# Ingredient, Strength table Ingredient Strength ALTERNARIA ALTERNATA 16 [hp_X]/mL ASPERGILLUS NIGER VAR. NIGER 16 [hp_X]/mL CANDIDA ALBICANS 16 [hp_X]/mL CANDIDA PARAPSILOSIS 16 [hp_X]/mL MUCOR RACEMOSUS 16 [hp_X]/mL ISSATCHENKIA ORIENTALIS WHOLE 16 [hp_C]/mL RHIZOPUS STOLONIFER 16 [hp_C]/mL CANDIDA TROPICALIS 32 [hp_C]/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 8 matching rows.
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83027-0068-1 Myco Sode 60 mL in 1 BOTTLE, SPRAY SPRAY 60 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83027-0068 MYCO SODE (ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, MUCOR RACEMOSUS, CANDIDA KRUSEI, RHIZOPUS NIGRICANS, CANDIDA TROPICALIS) SPRAY [NUTRITIONAL SPECIALTIES, INC.] 2 Current NDC, 1 package rows 20240913_4dbbd970-f3ad-4d96-9b54-7aa2c8323be2.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 Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Myco Sode ALTERNARIA TENUIS NEES, ASPERGILLUS NIGER, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, MUCOR RACEMOSUS, CANDIDA KRUSEI, RHIZOPUS NIGRICANS, CANDIDA TROPICALIS Nutritional Specialties, Inc. 4dbbd970-f3ad-4d96-9b54-7aa2c8323be2 2024-09-11 Warnings Exact identifier ndc (product): 83027-0068
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 83027-0068-1 83027006801 60 mL in 1 BOTTLE, SPRAY (83027-0068-1) 60 ml 2023-04-27 2028-05-19 No No Historical