FDA.reportPublic FDA data

NDC 58005-700 - BISMUSAL

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58005-700
Package NDCs from labels
58005-700-07
Manufacturer
Sparhawk Laboratories, Inc.
Effective date
2017-10-11
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
BISMUSAL SUSPENSION Anti-Diarrheal LiquidSparhawk Laboratories, Inc.2017-10-11OTC ANIMAL DRUG LABEL

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58005-700BISMUSAL (BISMUTH SUBSALICYLATE) SUSPENSION [SPARHAWK LABORATORIES, INC.]9Unmatched20171011_d685ed87-5059-4a68-8cfa-2cea2f7ed749.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1BISMUSAL (BISMUTH SUBSALICYLATE) SUSPENSION [SPARHAWK LABORATORIES, INC.]8
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEBISMUSAL (BISMUTH SUBSALICYLATE) SUSPENSION [SPARHAWK LABORATORIES, INC.]8

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 11 of 11 · 211 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stomach Relief Original StrengthBISMUTH SUBSALICYLATETopCo Associates, LLCe4b1929c-0967-44ea-8552-6549aa2a464e2018-12-14WarningsExact identifier
unii: 62TEY51RR1
BismuthBISMUTH SUBSALICYLATEAllegiant Health015ca07a-f6b5-4741-a7b0-821cf6d4e4182018-11-07WarningsExact identifier
unii: 62TEY51RR1
GastrobizBISMUTH SUBSALICYLATEAllegiant Healthaa516512-afd7-453f-9c73-5fa930cafac32018-09-11WarningsExact identifier
unii: 62TEY51RR1
Pepto ReliefBISMUTH SUBSALICYLATEAdvance Pharmaceutical Inc.a02babe7-9255-44c7-90e1-b5ad5e59c72a2017-12-22WarningsExact identifier
unii: 62TEY51RR1
Pep TumBISMUTH SUBSALICYLATEFirst Aid Directbf966e9f-2f95-41cd-a6e5-b8eb521181d82017-12-22WarningsExact identifier
unii: 62TEY51RR1
Stomach ReliefBISMUTH SUBSALICYLATECVS PHARMACY, INC.65dbe287-4528-4dbd-9116-6d4812fd4fa22017-11-28WarningsExact identifier
unii: 62TEY51RR1
Stomach ReliefBISMUTH SUBSALICYLATEPuraCap Pharmaceutical LLC01a4782f-93af-4d30-8ca3-7b39c272f60e2017-11-28WarningsExact identifier
unii: 62TEY51RR1
Pepto ReliefBISMUTH SUBSALICYLATERichmond Pharmaceuticals, Inca6f383b4-47f9-4837-93e2-2ca114fb20b92017-10-30WarningsExact identifier
unii: 62TEY51RR1
Stomach reliefBISMUTH SUBSALICYLATECVS53cf4590-a625-42f7-bd03-8401d08b64472017-08-08WarningsExact identifier
unii: 62TEY51RR1
Maximum strength Stomach ReliefBISMUTH SUBSALICYLATECVS75326a55-7cf3-411e-96a3-a6aef6c35ca52017-08-08WarningsExact identifier
unii: 62TEY51RR1
Bismuth ChewableBISMUTH SUBSALICYLATE 262 MGMarc Glassman, Inc.cdfcfdc2-ed5e-49d8-b16f-e32748d82e3e2016-12-19WarningsExact identifier
unii: 62TEY51RR1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.