FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
37000-441
Requested package NDC
37000-441-16
11-digit product format
370000441
Labeler code
37000
Product ID
37000-441_463f92ab-5f79-b8da-e063-6294a90ad7ca
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
The Procter & Gamble Manufacturing Company
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-03-01
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto-Bismol
Brand name suffix
Ultra Cherry
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
211915Internal RxNorm lookup
308763Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
6738f781-85a9-49a9-e053-2991aa0a786fAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-441-042021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-042021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-042021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-082021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-082021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-082021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-122021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-122021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-122021-02-12Pepto Bismol ® ULTRA CHERRY
37000-441-042021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-042021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-042021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-082021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-082021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-082021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-122021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-122021-01-29Pepto Bismol ® ULTRA CHERRY
37000-441-122021-01-29Pepto Bismol ® ULTRA CHERRY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-441-12Pepto-BismolUltra Cherry354 mL in 1 BOTTLE, PLASTICSUSPENSION35411
37000-441-16Pepto-BismolUltra Cherry473 mL in 1 BOTTLE, PLASTICSUSPENSION47311
37000-441-32Pepto-BismolUltra Cherry2 in 1 CARTONSUSPENSION211
37000-441-32Pepto-BismolUltra Cherry473 mL in 1 BOTTLE, PLASTICSUSPENSION47311

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-441PEPTO-BISMOL ULTRA CHERRY (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]8Current NDC, Legacy NDC, 4 package rows20241012_6738f781-85a9-49a9-e053-2991aa0a786f.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
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN6738f781-85a9-49a9-e053-2991aa0a786f11
211915Pepto-Bismol Max Strength 1050 MG in 30 mL Oral SuspensionPSN6738f781-85a9-49a9-e053-2991aa0a786f11
211915bismuth subsalicylate 35 MG/ML Oral Suspension [Pepto-bismol]SBD6738f781-85a9-49a9-e053-2991aa0a786f11
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD6738f781-85a9-49a9-e053-2991aa0a786f11
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY6738f781-85a9-49a9-e053-2991aa0a786f11
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY6738f781-85a9-49a9-e053-2991aa0a786f11
211915Pepto-bismol 35 MG/ML Oral SuspensionSY6738f781-85a9-49a9-e053-2991aa0a786f11
211915Pepto-bismol 525 MG per 15 ML Oral SuspensionSY6738f781-85a9-49a9-e053-2991aa0a786f11
211915Pepto-bismol Max Strength 1050 MG per 30 ML Oral SuspensionSY6738f781-85a9-49a9-e053-2991aa0a786f11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
37000-441-1637000044116473 mL in 1 BOTTLE, PLASTIC (37000-441-16) 473 ml2025-08-03NoNoCurrent