Kao-Bis

Product NDC
53807-503
11-digit product format
538070503
Labeler code
53807
Product ID
53807-503_91822e89-1b45-46b7-be5a-af2105b9a440
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Rij Pharmaceutical Corporation
Application
part335
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1999-03-16
Marketing end
0000-00-00
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/15mL
NDC exclude flag
No
Listing certified through
2019-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53807-503-082020-01-31C16284748780-19d75b9d0-7d4d-f424-e053-dadaa90a57ceDrug Facts
53807-503-122020-01-31C16284748780-19d75b9d0-7d4d-f424-e053-dadaa90a57ceDrug Facts
53807-503-162020-01-31C16284748780-19d75b9d0-7d4d-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53807-503-08Kao-Bis237 mL in 1 BOTTLELIQUID2372
53807-503-12Kao-Bis355 mL in 1 BOTTLELIQUID3552
53807-503-16Kao-Bis473 mL in 1 BOTTLELIQUID4732

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1KAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
CARBOXYMETHYLCELLULOSE SODIUMINACTIVE INGREDIENTK679OBS311KAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
FD&C RED NO. 3INACTIVE INGREDIENTPN2ZH5LOQYKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOAKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SACCHARIN SODIUMINACTIVE INGREDIENTSB8ZUX40TYKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SODIUM SALICYLATEINACTIVE INGREDIENTWIQ1H85SYPKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
SORBITOLINACTIVE INGREDIENT506T60A25RKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1
WATERINACTIVE INGREDIENT059QF0KO0RKAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53807-503KAO-BIS (BISMUTH SUBSALICYLATE) LIQUID [RIJ PHARMACEUTICAL CORPORATION]2Legacy NDC, 3 package rows20180502_cd0b0192-cd6a-4b4a-bed5-de734372829e.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNcd0b0192-cd6a-4b4a-bed5-de734372829e2
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDcd0b0192-cd6a-4b4a-bed5-de734372829e2
308762bismuth subsalicylate 1.75 % Oral SuspensionSYcd0b0192-cd6a-4b4a-bed5-de734372829e2
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYcd0b0192-cd6a-4b4a-bed5-de734372829e2
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYcd0b0192-cd6a-4b4a-bed5-de734372829e2
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYcd0b0192-cd6a-4b4a-bed5-de734372829e2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
53807-503-0853807050308237 mL in 1 BOTTLE237 mlHistorical
53807-503-1253807050312355 mL in 1 BOTTLE355 mlHistorical
53807-503-1653807050316473 mL in 1 BOTTLE473 mlHistorical