FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
37000-440
11-digit product format
370000440
Labeler code
37000
Product ID
37000-440_5d2c8e09-7e59-7b09-e063-6294a90a53f4
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
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Pepto-Bismol
Brand name suffix
Ultra
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/15mL

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
37000-440-042021-02-12Pepto Bismol ® ULTRA
37000-440-042021-02-12Pepto Bismol ® ULTRA
37000-440-042021-02-12Pepto Bismol ® ULTRA
37000-440-042021-02-12Pepto Bismol ® ULTRA
37000-440-082021-02-12Pepto Bismol ® ULTRA
37000-440-082021-02-12Pepto Bismol ® ULTRA
37000-440-082021-02-12Pepto Bismol ® ULTRA
37000-440-082021-02-12Pepto Bismol ® ULTRA
37000-440-122021-02-12Pepto Bismol ® ULTRA
37000-440-122021-02-12Pepto Bismol ® ULTRA
37000-440-122021-02-12Pepto Bismol ® ULTRA
37000-440-122021-02-12Pepto Bismol ® ULTRA
37000-440-042021-01-29Pepto Bismol ® ULTRA
37000-440-042021-01-29Pepto Bismol ® ULTRA
37000-440-042021-01-29Pepto Bismol ® ULTRA
37000-440-042021-01-29Pepto Bismol ® ULTRA
37000-440-082021-01-29Pepto Bismol ® ULTRA
37000-440-082021-01-29Pepto Bismol ® ULTRA
37000-440-082021-01-29Pepto Bismol ® ULTRA
37000-440-082021-01-29Pepto Bismol ® ULTRA
37000-440-122021-01-29Pepto Bismol ® ULTRA
37000-440-122021-01-29Pepto Bismol ® ULTRA
37000-440-122021-01-29Pepto Bismol ® ULTRA
37000-440-122021-01-29Pepto Bismol ® ULTRA

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-440-04Pepto-BismolUltra118 mL in 1 BOTTLE, PLASTICSUSPENSION11812
37000-440-08Pepto-BismolUltra236 mL in 1 BOTTLE, PLASTICSUSPENSION23612
37000-440-12Pepto-BismolUltra354 mL in 1 BOTTLE, PLASTICSUSPENSION35412
37000-440-36Pepto-BismolUltra354 mL in 1 BOTTLE, PLASTICSUSPENSION35412
37000-440-36Pepto-BismolUltra3 in 1 CELLO PACKSUSPENSION312

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-440PEPTO-BISMOL ULTRA (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]10Current NDC, Legacy NDC, 5 package rows20241012_673893bd-f8e9-23b0-e053-2a91aa0aa1d4.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 5 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Walgreen Stomach ReliefBISMUTH SUBSALICYLATEWALGREENS CO.53fdceb2-68ea-42b9-87eb-f202e96eb5242025-11-25WarningsExact identifier
application number: M008
WalgreenBISMUTH SUBSALICYLATEWALGREEN CO.73231515-840f-4086-86da-4b815d664c132025-11-25WarningsExact identifier
application number: M008
Percy MedicineBISMUTH SUBSALICYLATEMerrick Medicine Company, Inc08dd53b7-8345-4849-9155-60429cbe2c512025-11-11WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)d28ef2ae-2b0a-4f32-9bc1-6803806f3c812025-11-11WarningsExact identifier
application number: M008
TopCare Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLC2619720a-d926-4b17-899c-54d49c78802c2025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Regular StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCb93a0b38-eb5f-47c0-8112-75505e46f7c32025-11-10WarningsExact identifier
application number: M008
TopCare Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATETOPCO ASSOCIATES LLCe745e693-9e45-43b0-b26c-99ca891b74b02025-11-10WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)6298b856-90ea-4054-bda3-70f92b14611d2025-11-10WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEFamily Dollar (FAMILY WELLNESS)61309786-96ee-4d9b-8dd3-8e4a91ebe88c2025-11-07WarningsExact identifier
application number: M008
up and up digestive reliefBISMUTH SUBSALICYLATETarget Corporation5731025d-ffaa-4b31-971f-e58b921e40ed2025-11-05WarningsExact identifier
application number: M008
ULTRA STRENGHT PINK BISMUTHBISMUTH SUBSALICYLATETARGET CORPORATION20063215-f657-487b-9530-6df0181b440a2025-11-05WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation7f6b2960-943d-464c-9ff9-4649a8ab4a4e2025-11-04WarningsExact identifier
application number: M008
up and up 5-symptom digestive reliefBISMUTH SUBSALICYLATETarget Corporation6462e224-5ee7-4556-90f2-994eaf89b71b2025-11-04WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATESAFEWAYba698d38-83f1-4257-9c43-e7a55dbb206e2025-10-29WarningsExact identifier
application number: M008
Digestive ReliefBISMUTH SUBSALICYLATESAFEWAY5538d56a-b258-4260-b51b-f5131bd768852025-10-29WarningsExact identifier
application number: M008
Chewable Stomach ReliefBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS INC,2a316e06-5c16-46b8-b9ac-71fe0f92c5152025-10-28WarningsExact identifier
application number: M008
PUBLIX Regular Strength Pink BismuthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INCa9b2da55-5171-4702-9808-5b937182da022025-10-28WarningsExact identifier
application number: M008
PUBLIX Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATEPUBLIX SUPER MARKETS, INC4be86e84-fddf-4eb5-a519-64009d0e69fc2025-10-28WarningsExact identifier
application number: M008
Pepto-BismolBISMUTH SUBSALICYLATEASCLEMED USA INC.01b318d2-586d-4953-8f98-addc4e3cd4412025-10-15WarningsExact identifier
application number: M008
KaopectateBISMUTH SUBSALICYLATEKRAMER LABORATORIES18b79c8c-b2fd-449b-a154-7158c9b13cdd2025-10-15WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-Bismol Max Strength 1050 MG in 30 mL Oral SuspensionPSN673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915bismuth subsalicylate 35 MG/ML Oral Suspension [Pepto-bismol]SBD673893bd-f8e9-23b0-e053-2a91aa0aa1d412
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD673893bd-f8e9-23b0-e053-2a91aa0aa1d412
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-bismol 35 MG/ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-bismol 525 MG per 15 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412
211915Pepto-bismol Max Strength 1050 MG per 30 ML Oral SuspensionSY673893bd-f8e9-23b0-e053-2a91aa0aa1d412

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-440-0437000044004118 mL in 1 BOTTLE, PLASTIC (37000-440-04) 118 ml2018-03-010000-00-00NoNoCurrent
37000-440-0837000044008236 mL in 1 BOTTLE, PLASTIC (37000-440-08) 236 ml2018-03-010000-00-00NoNoCurrent
37000-440-1237000044012354 mL in 1 BOTTLE, PLASTIC (37000-440-12) 354 ml2018-03-010000-00-00NoNoCurrent
37000-440-36370000440363 BOTTLE, PLASTIC in 1 CELLO PACK (37000-440-36) / 354 mL in 1 BOTTLE, PLASTIC2024-07-01NoNoCurrent