FDA.reportPublic FDA data

Pink-Bismuth

Product NDC
53041-527
11-digit product format
530410527
Labeler code
53041
Product ID
53041-527_13b52b6e-d8cb-476e-a8af-e6df6d02b22f
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
LIQUID
Route
ORAL
Labeler
Guardian Drug Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2008-05-30
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/15mL
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
Pink-Bismuth
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
62TEY51RR1Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
cb7da2b4-5e44-488b-a6e7-362e9b06c49cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53041-527-03Pink-Bismuth118 mL in 1 BOTTLELIQUID1186
53041-527-04Pink-Bismuth236 mL in 1 BOTTLELIQUID2366
53041-527-05Pink-Bismuth354 mL in 1 BOTTLELIQUID3546
53041-527-06Pink-Bismuth473 mL in 1 BOTTLELIQUID4736

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1PINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
BISMUTH CATIONACTIVE MOIETYZS9CD1I8YEPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
BENZOIC ACIDINACTIVE INGREDIENT8SKN0B0MIMPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
D&C RED NO. 22INACTIVE INGREDIENT1678RKX8RTPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
D&C RED NO. 28INACTIVE INGREDIENT767IP0Y5NHPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1OPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)INACTIVE INGREDIENTS38J6RZN16PINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
POTASSIUM HYDROXIDEINACTIVE INGREDIENTWZH3C48M4TPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
SACCHARIN SODIUM DIHYDRATEINACTIVE INGREDIENTSB8ZUX40TYPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
SALICYLIC ACIDINACTIVE INGREDIENTO414PZ4LPZPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
WATERINACTIVE INGREDIENT059QF0KO0RPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEPINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53041-527PINK-BISMUTH (BISMUTH SUBSALICYLATE) LIQUID [GUARDIAN DRUG COMPANY]5Current NDC, Legacy NDC, 4 package rows20241220_cb7da2b4-5e44-488b-a6e7-362e9b06c49c.zip

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 1 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach ReliefBISMUTH SUBSALICYLATEH E B7d721ce3-746f-49aa-916d-eb5a8b3578132026-08-21WarningsExact identifier
application number: M008
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporatione8107300-921c-4ba4-ad6e-f4cf1cd5c2952026-08-20WarningsExact identifier
application number: M008
CVS Health Anti-Diarrheal VanillaBISMUTH SUBSALICYLATECVS Pharmacy,Inc.ce1ed357-228b-452c-9bd4-6b0d20f41c1d2026-08-17WarningsExact identifier
application number: M008
CVS Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECVS PHARMACYa7fb56c5-9b34-48b8-a355-a16979a0aa7b2026-08-17WarningsExact identifier
application number: M008
regular strength pink bismuthBISMUTH SUBSALICYLATECVS PHARMACY, INC.2b2a1de0-12fa-4800-91e8-f70a405eec722026-08-17WarningsExact identifier
application number: M008
CVS Health Stomach relief Cherry FlavorBISMUTH SUBSALICYLATECVS PHARMACY,INC.c0bb2b6e-8187-495e-8eac-2324fae86cf52026-08-13WarningsExact identifier
application number: M008
CVS Stomach ReliefBISMUTH SUBSALICYLATECVSeb96b2bb-7b2a-4664-96ac-73c917c84c302026-08-13WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)1af2a7dd-45d7-41a0-af61-4a588f1c19852026-08-12WarningsExact identifier
application number: M008
WinCo FOODS Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODSacf82012-0e40-4d50-b1f1-f36dc3dfad842026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS19c14efc-bf5f-4ef5-a727-aaccfae093f02026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS LLC53ae695d-f812-462d-9487-8fb5db0aa27d2026-08-07WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEShield Pharmaceuticals Corp8177318d-427b-4bfc-9d7f-51d1545f4eb82026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companybb8d2ed8-54a2-2295-e053-2995a90a10ac2026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companycfe9214d-25e9-7729-e053-2a95a90a0dfb2026-07-27WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company252b143f-eee8-f407-e063-6394a90a0a082026-07-27WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d20af4fb-d579-4d1e-86ae-342933f4de752026-07-15WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSNcb7da2b4-5e44-488b-a6e7-362e9b06c49c6
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCDcb7da2b4-5e44-488b-a6e7-362e9b06c49c6
308762bismuth subsalicylate 1.75 % Oral SuspensionSYcb7da2b4-5e44-488b-a6e7-362e9b06c49c6
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSYcb7da2b4-5e44-488b-a6e7-362e9b06c49c6
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSYcb7da2b4-5e44-488b-a6e7-362e9b06c49c6
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSYcb7da2b4-5e44-488b-a6e7-362e9b06c49c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53041-527-0353041052703118 mL in 1 BOTTLE (53041-527-03) 118 ml2008-05-300000-00-00NoNoCurrent
53041-527-0453041052704236 mL in 1 BOTTLE (53041-527-04) 236 ml2008-05-300000-00-00NoNoCurrent
53041-527-0553041052705354 mL in 1 BOTTLE (53041-527-05) 354 ml2008-05-300000-00-00NoNoCurrent
53041-527-0653041052706473 mL in 1 BOTTLE (53041-527-06) 473 ml2008-05-300000-00-00NoNoCurrent