Regular Strength

Product NDC
68163-706
11-digit product format
681630706
Labeler code
68163
Product ID
68163-706_3fee5b54-b0a6-1ccc-e063-6294a90addeb
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
Raritan Pharmaceuticals Inc
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-05-13
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Regular Strength
Brand name suffix
Pink Bismuth
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308762

DailyMed Product Concepts#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68163-706-04Regular StrengthPink Bismuth118 mL in 1 BOTTLESUSPENSION1188
68163-706-12Regular StrengthPink Bismuth354 mL in 1 BOTTLESUSPENSION3548

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68163-706REGULAR STRENGTH PINK BISMUTH (BISMUTH SUBSALICYLATE) SUSPENSION [RARITAN PHARMACEUTICALS INC]7Current NDC, Legacy NDC, 2 package rows20241124_89d18117-f0af-408a-a5ae-19da84158806.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN89d18117-f0af-408a-a5ae-19da841588068
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD89d18117-f0af-408a-a5ae-19da841588068
308762bismuth subsalicylate 1.75 % Oral SuspensionSY89d18117-f0af-408a-a5ae-19da841588068
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY89d18117-f0af-408a-a5ae-19da841588068
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY89d18117-f0af-408a-a5ae-19da841588068
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY89d18117-f0af-408a-a5ae-19da841588068

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68163-706-0468163070604118 mL in 1 BOTTLE (68163-706-04) 118 ml2019-05-130000-00-00NoNoCurrent
68163-706-1268163070612354 mL in 1 BOTTLE (68163-706-12) 354 ml2019-05-130000-00-00NoNoCurrent