FDA.reportPublic FDA data

Bowel Sode

Product NDC
83027-0072
11-digit product format
830270072
Labeler code
83027
Product ID
83027-0072_ff55e1dd-b526-40f9-bc18-bab8c672add7
Type
HUMAN OTC DRUG
Nonproprietary name
Ascaris Lumbricoides, Borrelia Burgdorferi, Botulinum, Colibacillinum Cum Natrum Muriaticum, Enterobius Vermicularis, Giardia Lamblia, Helicobacter Pylori, Proteus (Vulgaris), Trichinella Spiralis, Enterococcus Faecalis, Taenia Saginatta, Taenia Solium, Adenoviren Nosode, Campylobacter Jejuni, Clostridium Perfringens, Dysentery Bacillus, Clostridium Difficile, Entamoeba Histolytica
Dosage form
SPRAY
Route
ORAL
Labeler
Nutritional Specialties, Inc.
Marketing category
UNAPPROVED HOMEOPATHIC
Marketing start
2023-09-15
Marketing end
2028-09-20
Substance
ASCARIS LUMBRICOIDES; BORRELIA BURGDORFERI; CLOSTRIDIUM BOTULINUM; ESCHERICHIA COLI; ENTEROBIUS VERMICULARIS; GIARDIA LAMBLIA; HELICOBACTER PYLORI; PROTEUS VULGARIS; TRICHINELLA SPIRALIS; ENTEROCOCCUS FAECALIS; TAENIA SAGINATA; TAENIA SOLIUM; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; CAMPYLOBACTER JEJUNI; CLOSTRIDIUM PERFRINGENS; SHIGELLA DYSENTERIAE; CLOSTRIDIUM DIFFICILE; ENTAMOEBA HISTOLYTICA
Active strength
16; 16; 16; 16; 16; 16; 16; 16; 16; 20; 8; 8; 12; 12; 18; 18; 32; 32 [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_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL
Pharmacologic classes
Actively Acquired Immunity [PE], Live Human Adenovirus Type 4 Vaccine [EPC], Vaccines, Adenovirus [Chemical/Ingredient], Vaccines, Live, Unattenuated [Chemical/Ingredient]
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
Bowel Sode

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ASCARIS LUMBRICOIDES16 [hp_X]/mL
BORRELIA BURGDORFERI16 [hp_X]/mL
CLOSTRIDIUM BOTULINUM16 [hp_X]/mL
ESCHERICHIA COLI16 [hp_X]/mL
ENTEROBIUS VERMICULARIS16 [hp_X]/mL
GIARDIA LAMBLIA16 [hp_X]/mL
HELICOBACTER PYLORI16 [hp_X]/mL
PROTEUS VULGARIS16 [hp_X]/mL
TRICHINELLA SPIRALIS16 [hp_X]/mL
ENTEROCOCCUS FAECALIS20 [hp_X]/mL
TAENIA SAGINATA8 [hp_C]/mL
TAENIA SOLIUM8 [hp_C]/mL
HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN12 [hp_C]/mL
CAMPYLOBACTER JEJUNI12 [hp_C]/mL
CLOSTRIDIUM PERFRINGENS18 [hp_C]/mL
SHIGELLA DYSENTERIAE18 [hp_C]/mL
CLOSTRIDIUM DIFFICILE32 [hp_C]/mL
ENTAMOEBA HISTOLYTICA32 [hp_C]/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 18 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
5694HE17ZQInternal UNII lookup
0J8NV9V5Q8Internal UNII lookup
0296055VE0Internal UNII lookup
514B9K0L10Internal UNII lookup
W1D68QW48MInternal UNII lookup
89IEJ09R73Internal UNII lookup
U09W5JOL3ZInternal UNII lookup
11T9HCO30OInternal UNII lookup
2PYI6D7HCQInternal UNII lookup
15E04LZ9CTInternal UNII lookup
O27XH54AICInternal UNII lookup
80CZ5Z3WH3Internal UNII lookup
FKD3DUK39IInternal UNII lookup
5U38E02853Internal UNII lookup
OVP6XX033EInternal UNII lookup
1EP6R5562JInternal UNII lookup
PJX89V9R6NInternal UNII lookup
2XC2HJ478WInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
caf62710-f8f0-4ca5-b3ac-6bc79af044a5Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83027-0072-1Bowel Sode60 mL in 1 BOTTLE, SPRAYSPRAY602

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
83027-0072BOWEL SODE (ASCARIS LUMBRICOIDES, BORRELIA BURGDORFERI, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, ENTEROBIUS VERMICULARIS, GIARDIA LAMBLIA, HELICOBACTER PYLORI, PROTEUS (VULGARIS), TRICHINELLA SPIRALIS, ENTEROCOCCUS FAECALIS, TAENIA SAGINATTA, TAENIA SOLIUM, ADENOVIREN NOSODE, CAMPYLOBACTER JEJUNI, CLOSTRIDIUM PERFRINGENS, DYSENTERY BACILLUS, CLOSTRIDIUM DIFFICILE, ENTAMOEBA HISTOLYTICA) SPRAY [NUTRITIONAL SPECIALTIES, INC.]2Current NDC, 1 package rows20241102_caf62710-f8f0-4ca5-b3ac-6bc79af044a5.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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bowel SodeASCARIS LUMBRICOIDES, BORRELIA BURGDORFERI, BOTULINUM, COLIBACILLINUM CUM NATRUM MURIATICUM, ENTEROBIUS VERMICULARIS, GIARDIA LAMBLIA, HELICOBACTER PYLORI, PROTEUS (VULGARIS), TRICHINELLA SPIRALIS, ENTEROCOCCUS FAECALIS, TAENIA SAGINATTA, TAENIA SOLIUM, ADENOVIREN NOSODE, CAMPYLOBACTER JEJUNI, CLOSTRIDIUM PERFRINGENS, DYSENTERY BACILLUS, CLOSTRIDIUM DIFFICILE, ENTAMOEBA HISTOLYTICANutritional Specialties, Inc.caf62710-f8f0-4ca5-b3ac-6bc79af044a52024-10-31WarningsExact identifier
ndc (product): 83027-0072

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
83027-0072-18302700720160 mL in 1 BOTTLE, SPRAY (83027-0072-1) 60 ml2023-09-152028-09-20NoNoHistorical