FDA.reportPublic FDA data

Sinus Defense 2.0

Product NDC
83018-0005
11-digit product format
830180005
Labeler code
83018
Product ID
83018-0005_44ce6615-e1a5-4fe4-9b05-e787b94eb2c1
Type
HUMAN OTC DRUG
Nonproprietary name
Lac Vaccinum, Silicea, Aspergillus Niger, Babesia Microti, Borrelia Burgdorferi, Candida Albicans, Candida Parapsilosis, Chlamydia Trachomatis, Colibacillinum Cum Natrum Muriaticum, Cytomegalovirus Nosode, Ehrlichia Nosode, Herpes Simplex I and II Nosode, Human Papilloma Nosode, Klebsiella Pneumoniae, Mucor Racemosus, Mycobacterium Paratuberculosis, Pneumoccoccinum, Staphylococcus Aureus, Streptococcus Viridans, Epstein-Barr Virus Nosode, Herpes Zoster Nosode
Dosage form
SPRAY
Route
ORAL
Labeler
Micro Balance Health Products LLC
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2026-03-04
Substance
ASPERGILLUS NIGER VAR. NIGER; BABESIA MICROTI; BORRELIA BURGDORFERI; CANDIDA ALBICANS; CANDIDA PARAPSILOSIS; CHLAMYDIA TRACHOMATIS; COW MILK; EHRLICHIA CANIS; ESCHERICHIA COLI; HUMAN HERPESVIRUS 1; HUMAN HERPESVIRUS 2; HUMAN HERPESVIRUS 3; HUMAN HERPESVIRUS 4; HUMAN HERPESVIRUS 5; HUMAN PAPILLOMAVIRUS; KLEBSIELLA PNEUMONIAE; MUCOR RACEMOSUS; MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS; SILICON DIOXIDE; STAPHYLOCOCCUS AUREUS; STREPTOCOCCUS PNEUMONIAE; STREPTOCOCCUS VIRIDANS GROUP
Active strength
16; 16; 16; 16; 16; 16; 6; 16; 16; 30; 30; 15; 15; 16; 16; 16; 16; 16; 9; 16; 16; 16 [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; [hp_X]/mL; [hp_C]/mL; [hp_C]/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], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Cell-mediated Immunity [PE], Dietary 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 IgG Production [PE], Increased IgG Production [PE], Increased IgG Production [PE], Milk Proteins [CS], Non-Standardized Food 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
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Sinus Defense 2.0
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
COW MILK6 [hp_X]/mL
SILICON DIOXIDE9 [hp_X]/mL
ASPERGILLUS NIGER VAR. NIGER16 [hp_X]/mL
BABESIA MICROTI16 [hp_X]/mL
BORRELIA BURGDORFERI16 [hp_X]/mL
CANDIDA ALBICANS16 [hp_X]/mL
CANDIDA PARAPSILOSIS16 [hp_X]/mL
CHLAMYDIA TRACHOMATIS16 [hp_X]/mL
ESCHERICHIA COLI16 [hp_X]/mL
HUMAN HERPESVIRUS 516 [hp_X]/mL
EHRLICHIA CANIS16 [hp_X]/mL
HUMAN HERPESVIRUS 130 [hp_X]/mL
HUMAN HERPESVIRUS 230 [hp_X]/mL
HUMAN PAPILLOMAVIRUS16 [hp_X]/mL
KLEBSIELLA PNEUMONIAE16 [hp_X]/mL
MUCOR RACEMOSUS16 [hp_X]/mL
MYCOBACTERIUM AVIUM SUBSP. PARATUBERCULOSIS16 [hp_X]/mL
STREPTOCOCCUS PNEUMONIAE16 [hp_X]/mL
STAPHYLOCOCCUS AUREUS16 [hp_X]/mL
STREPTOCOCCUS VIRIDANS GROUP16 [hp_X]/mL
HUMAN HERPESVIRUS 415 [hp_C]/mL
HUMAN HERPESVIRUS 315 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 2 · 22 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
917J3173FTInternal UNII lookup
ETJ7Z6XBU4Internal UNII lookup
9IOA40ANG6Internal UNII lookup
1948X6KEG3Internal UNII lookup
0J8NV9V5Q8Internal UNII lookup
4D7G21HDBCInternal UNII lookup
0KZ676D44NInternal UNII lookup
T6NI39QU44Internal UNII lookup
514B9K0L10Internal UNII lookup
7COI029E6KInternal UNII lookup
970Y8T1JZYInternal UNII lookup
22G38P19RLInternal UNII lookup
74J6DNH49UInternal UNII lookup
23CVL7WF4JInternal UNII lookup
09PA36CT5RInternal UNII lookup
17RH99LQ7GInternal UNII lookup
XH0F4IP2RXInternal UNII lookup
BT6U234YR2Internal UNII lookup
O478WX4004Internal UNII lookup
NNV2379HKRInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
560f84f6-2544-4ba8-8236-a95906eb7d97Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83018-0005-1Sinus Defense 2.060 mL in 1 BOTTLE, SPRAYSPRAY601

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
Sinus Defense 2.0LAC VACCINUM, SILICEA, ASPERGILLUS NIGER, BABESIA MICROTI, BORRELIA BURGDORFERI, CANDIDA ALBICANS, CANDIDA PARAPSILOSIS, CHLAMYDIA TRACHOMATIS, COLIBACILLINUM CUM NATRUM MURIATICUM, CYTOMEGALOVIRUS NOSODE, EHRLICHIA NOSODE, HERPES SIMPLEX I AND II NOSODE, HUMAN PAPILLOMA NOSODE, KLEBSIELLA PNEUMONIAE, MUCOR RACEMOSUS, MYCOBACTERIUM PARATUBERCULOSIS, PNEUMOCCOCCINUM, STAPHYLOCOCCUS AUREUS, STREPTOCOCCUS VIRIDANS, EPSTEIN-BARR VIRUS NOSODE, HERPES ZOSTER NOSODEMicro Balance Health Products LLC560f84f6-2544-4ba8-8236-a95906eb7d972026-03-04WarningsExact identifier
ndc (product): 83018-0005

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83018-0005-18301800050160 mL in 1 BOTTLE, SPRAY (83018-0005-1) 60 ml2026-03-04NoNoCurrent