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; CAMPYLOBACTER JEJUNI; CLOSTRIDIUM BOTULINUM; CLOSTRIDIUM DIFFICILE; CLOSTRIDIUM PERFRINGENS; ENTAMOEBA HISTOLYTICA; ENTEROBIUS VERMICULARIS; ENTEROCOCCUS FAECALIS; ESCHERICHIA COLI; GIARDIA LAMBLIA; HELICOBACTER PYLORI; HUMAN ADENOVIRUS E SEROTYPE 4 STRAIN CL-68578 ANTIGEN; PROTEUS VULGARIS; SHIGELLA DYSENTERIAE; TAENIA SAGINATA; TAENIA SOLIUM; TRICHINELLA SPIRALIS
Active strength
16; 16; 12; 16; 32; 18; 32; 16; 20; 16; 16; 16; 12; 16; 18; 8; 8; 16 [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_X]/mL; [hp_C]/mL; [hp_X]/mL; [hp_C]/mL; [hp_C]/mL; [hp_C]/mL; [hp_X]/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

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

Harmonized Identifiers#

Field, Values table
FieldValues
Unii5694HE17ZQ, 0J8NV9V5Q8, 5U38E02853, 0296055VE0, PJX89V9R6N, OVP6XX033E, 2XC2HJ478W, W1D68QW48M, 15E04LZ9CT, 514B9K0L10, 89IEJ09R73, U09W5JOL3Z, FKD3DUK39I, 11T9HCO30O, 1EP6R5562J, O27XH54AIC, 80CZ5Z3WH3, 2PYI6D7HCQ

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

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