FDA.reportPublic FDA data

Kroger Regular Strength

Product NDC
30142-608
11-digit product format
301420608
Labeler code
30142
Product ID
30142-608_3b883670-1d1d-3a4e-e063-6294a90a3d14
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
KROGER COMPANY
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-03-30
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
Kroger 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
30142-608-08Kroger Regular StrengthPink Bismuth236 mL in 1 BOTTLESUSPENSION2367
30142-608-12Kroger Regular StrengthPink Bismuth354 mL in 1 BOTTLESUSPENSION3547
30142-608-16Kroger Regular StrengthPink Bismuth473 mL in 1 BOTTLESUSPENSION4737
30142-608-32Kroger Regular StrengthPink Bismuth2 in 1 CELLO PACKSUSPENSION27
30142-608-32Kroger Regular StrengthPink Bismuth473 mL in 1 BOTTLESUSPENSION4737

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30142-608KROGER REGULAR STRENGTH PINK BISMUTH (BISMUTH SUBSALICYLATE) SUSPENSION [KROGER COMPANY]6Current NDC, Legacy NDC, 5 package rows20240712_97175691-4881-450d-a14c-3413ab47a3ca.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN97175691-4881-450d-a14c-3413ab47a3ca7
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD97175691-4881-450d-a14c-3413ab47a3ca7
308762bismuth subsalicylate 1.75 % Oral SuspensionSY97175691-4881-450d-a14c-3413ab47a3ca7
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY97175691-4881-450d-a14c-3413ab47a3ca7
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY97175691-4881-450d-a14c-3413ab47a3ca7
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY97175691-4881-450d-a14c-3413ab47a3ca7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30142-608-0830142060808236 mL in 1 BOTTLE (30142-608-08) 236 ml2020-03-300000-00-00NoNoCurrent
30142-608-1230142060812354 mL in 1 BOTTLE (30142-608-12) 354 ml2020-03-300000-00-00NoNoCurrent
30142-608-1630142060816473 mL in 1 BOTTLE (30142-608-16) 473 ml2024-06-24NoNoHistorical
30142-608-32301420608322 BOTTLE in 1 CELLO PACK (30142-608-32) / 473 mL in 1 BOTTLE2 bottle2024-06-24NoNoHistorical