FDA.reportPublic FDA data

Bismuth Subsalicylate 262 mg

Product NDC
69618-029
Requested package NDC
69618-029-03
11-digit product format
696180029
Labeler code
69618
Product ID
69618-029_2bc8473d-ad00-da1d-e063-6394a90ae0d4
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
Reliable 1 Laboratories LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-11-01
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
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
Bismuth Subsalicylate 262 mg
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

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
308761Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e40ffd8-1afa-43af-e054-00144ff8d46cAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69618-029-032023-03-29C16284748780-1f386c64a-2128-0266-e053-dadaa90a7c1aBismuth Subsalicylate 262 mg
69618-029-032023-01-30C16284748780-1f386c64a-2128-0266-e053-dadaa90a7c1aBismuth Subsalicylate 262 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69618-029-03Bismuth Subsalicylate 262 mg30 in 1 BOTTLE, PLASTICTABLET, CHEWABLE306

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69618-029-03EA - Each69618-0292346e47b-3b4e-455a-883c-927f7f93195b12016-05-16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69618-029BISMUTH SUBSALICYLATE 262 MG (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [RELIABLE 1 LABORATORIES LLC]6Current NDC, Legacy NDC, 1 package rows20250117_2e40ffd8-1afa-43af-e054-00144ff8d46c.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 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
Stomach ReliefBISMUTH SUBSALICYLATEWALMART INC. (see also Equate)369fe912-dd0e-4ff3-a597-5ee81332838a2026-07-15WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)642c14bd-be99-410b-9ba7-6e71c97052302026-07-15WarningsExact identifier
application number: M008
Good Neighbor Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEAMERISOURCE BERGEN71c30b10-db24-4a42-a4f4-db552e3d5fe62026-07-13WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATESelect Consumer Group5611c6cb-5c0b-cf4e-e063-6394a90abff82026-07-07WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERugby Laboratories6166c04e-20c6-4678-b16d-5174744456982026-06-26WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens394e16b8-dd7c-4c68-86ce-3623936745a72026-06-25WarningsExact identifier
application number: M008
Stomach Relief regular strengthBISMUTH SUBSALICYLATECVS Pharmacy1aa386ac-8ffd-4ba4-9b2e-19156d374c482026-06-25WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWalgreensc367d913-e37b-467a-84da-dd6a22c793ae2026-06-25WarningsExact identifier
application number: M008
Bismuth Subsalicylate Pink BismuthBISMUTH SUBSALICYLATEHyvee Inc4e575573-9ded-bfbf-e063-6394a90aed3b2026-06-23WarningsExact identifier
application number: M008
Stomach relieverBISMUTH SUBSALICYLATEHyvee Inc44ead6e1-cd88-4602-e063-6394a90aed9f2026-06-16WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f7627bf1-da97-4875-b614-5029663f74822026-06-08WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN2e40ffd8-1afa-43af-e054-00144ff8d46c6
308761bismuth subsalicylate 262 MG Chewable TabletSCD2e40ffd8-1afa-43af-e054-00144ff8d46c6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
69618-029-036961800290330 TABLET, CHEWABLE in 1 BOTTLE, PLASTIC (69618-029-03) 2015-11-010000-00-00NoNoCurrent