FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
37000-438
11-digit product format
370000438
Labeler code
37000
Product ID
37000-438_5d2c9a5e-039b-7740-e063-6394a90a4b1f
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/30mL
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/30mL

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
37000-438-042021-02-11Pepto Bismol ®
37000-438-042021-02-11Pepto Bismol ®
37000-438-042021-02-11Pepto Bismol ®
37000-438-042021-02-11Pepto Bismol ®
37000-438-082021-02-11Pepto Bismol ®
37000-438-082021-02-11Pepto Bismol ®
37000-438-082021-02-11Pepto Bismol ®
37000-438-082021-02-11Pepto Bismol ®
37000-438-122021-02-11Pepto Bismol ®
37000-438-122021-02-11Pepto Bismol ®
37000-438-122021-02-11Pepto Bismol ®
37000-438-122021-02-11Pepto Bismol ®
37000-438-162021-02-11Pepto Bismol ®
37000-438-162021-02-11Pepto Bismol ®
37000-438-162021-02-11Pepto Bismol ®
37000-438-162021-02-11Pepto Bismol ®
37000-438-242021-02-11Pepto Bismol ®
37000-438-242021-02-11Pepto Bismol ®
37000-438-242021-02-11Pepto Bismol ®
37000-438-242021-02-11Pepto Bismol ®
37000-438-322021-02-11Pepto Bismol ®
37000-438-322021-02-11Pepto Bismol ®
37000-438-322021-02-11Pepto Bismol ®
37000-438-322021-02-11Pepto Bismol ®
37000-438-342021-02-11Pepto Bismol ®
37000-438-342021-02-11Pepto Bismol ®
37000-438-342021-02-11Pepto Bismol ®
37000-438-342021-02-11Pepto Bismol ®
37000-438-042021-01-29Pepto Bismol ®
37000-438-042021-01-29Pepto Bismol ®
37000-438-042021-01-29Pepto Bismol ®
37000-438-042021-01-29Pepto Bismol ®
37000-438-082021-01-29Pepto Bismol ®
37000-438-082021-01-29Pepto Bismol ®
37000-438-082021-01-29Pepto Bismol ®
37000-438-082021-01-29Pepto Bismol ®
37000-438-122021-01-29Pepto Bismol ®
37000-438-122021-01-29Pepto Bismol ®
37000-438-122021-01-29Pepto Bismol ®
37000-438-122021-01-29Pepto Bismol ®
37000-438-162021-01-29Pepto Bismol ®
37000-438-162021-01-29Pepto Bismol ®
37000-438-162021-01-29Pepto Bismol ®
37000-438-162021-01-29Pepto Bismol ®
37000-438-242021-01-29Pepto Bismol ®
37000-438-242021-01-29Pepto Bismol ®
37000-438-242021-01-29Pepto Bismol ®
37000-438-242021-01-29Pepto Bismol ®
37000-438-322021-01-29Pepto Bismol ®
37000-438-322021-01-29Pepto Bismol ®
37000-438-322021-01-29Pepto Bismol ®
37000-438-322021-01-29Pepto Bismol ®
37000-438-342021-01-29Pepto Bismol ®
37000-438-342021-01-29Pepto Bismol ®
37000-438-342021-01-29Pepto Bismol ®
37000-438-342021-01-29Pepto Bismol ®

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37000-438-04Pepto-Bismol118 mL in 1 BOTTLE, PLASTICSUSPENSION11818
37000-438-08Pepto-Bismol236 mL in 1 BOTTLE, PLASTICSUSPENSION23618
37000-438-12Pepto-Bismol354 mL in 1 BOTTLE, PLASTICSUSPENSION35418
37000-438-16Pepto-Bismol473 mL in 1 BOTTLE, PLASTICSUSPENSION47318
37000-438-24Pepto-Bismol354 mL in 1 BOTTLE, PLASTICSUSPENSION35418
37000-438-24Pepto-Bismol2 in 1 CELLO PACKSUSPENSION218
37000-438-32Pepto-Bismol2 in 1 CELLO PACKSUSPENSION218
37000-438-32Pepto-Bismol473 mL in 1 BOTTLE, PLASTICSUSPENSION47318
37000-438-34Pepto-Bismol100 mL in 1 BOTTLE, PLASTICSUSPENSION10018

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37000-438PEPTO-BISMOL (BISMUTH SUBSALICYLATE) SUSPENSION [THE PROCTER & GAMBLE MANUFACTURING COMPANY]12Current NDC, Legacy NDC, 9 package rows20241012_67006e82-870d-8d63-e053-2991aa0a02d1.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 8 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Topcare Stomach Relief cherryBISMUTH SUBSALICYLATETopco Associates, LLC154b4b8f-c4d6-414b-aac3-88475669e19d2024-12-26WarningsExact identifier
application number: M008
Topco Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC7a5be682-f13b-41a4-bf8c-724bffab2e922024-12-26WarningsExact identifier
application number: M008
HEB Stomach Relief CherryBISMUTH SUBSALICYLATEH E B0277d4d7-c254-4eea-8f2e-4936d015a80f2024-12-26WarningsExact identifier
application number: M008
Equaline Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFI716a7b86-4f6e-493d-ba29-d81f6ecafbf22024-12-20WarningsExact identifier
application number: M008
Equaline Stomach ReliefBISMUTH SUBSALICYLATEUNITED NATURAL FOODS, INC. DBA UNFId0607a4e-de81-4881-abc7-cf0cc72a9f922024-12-20WarningsExact identifier
application number: M008
Guardian Pink BismuthBISMUTH SUBSALICYLATEGuardian Drug Company7e83fdf2-4007-46a8-ae9d-eab5a8ff19152024-12-18WarningsExact identifier
application number: M008
Stomach Relief, Caseys 4goodBISMUTH SUBSALICYLATE SUSPENSIONLil' Drug Store Products, Inc.030bb176-08ae-6c68-e063-6394a90af5272024-12-16WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCc73c6650-a7ac-4942-ae07-0bc660a0081f2024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Regular Strength Stomach Relief 527BISMUTH SUBSALICYLATE 525 MGStrategic Sourcing Services LLCf204f9ab-645b-4656-93a1-90aa4c3699222024-12-12WarningsExact identifier
application number: M008
Foster and Thrive Stomach ReliefBISMUTH SUBSALICYLATEStrategic Sourcing Services LLCd18cd615-912a-4853-bb2e-225960cfe08b2024-12-12WarningsExact identifier
application number: M008
Topcare Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATETopco Associates, LLC908da10c-2ed1-4917-a98b-bab63d7990d42024-12-09WarningsExact identifier
application number: M008
Careone Stomach ReliefBISMUTH SUBSALICYLATERetail Business Services, LLC.214f64c9-29e4-353d-e063-6294a90a12b42024-11-26WarningsExact identifier
application number: M008
Anti-DiarrhealBISMUTH SUBSALICYLATELil' Drug Store Products, Inc.079901b3-393b-44f0-85c9-2d8911f2a42a2024-11-25WarningsExact identifier
application number: M008
Firefly Anticavity FluorideSODIUM FLUORIDERanir LLCe91ed8a1-0d45-402c-9c16-1ae72e695a372024-11-20WarningsExact identifier
application number: M008
Rapidol Stomach ReliefBISMUTH SUBSALICYLATEPharmadel LLCefba1aea-f468-4f63-e053-2995a90a545b2024-11-18WarningsExact identifier
application number: M008
RITE AID Regular Strength Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION48fe12a5-5ff0-4d35-8708-675de32a9ed02024-10-31WarningsExact identifier
application number: M008
Rite Aid Digestive ReliefBISMUTH SUBSALICYLATERITE AID CORPORATION816c4ec4-46d1-4e8e-ad91-a11946c487692024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach ReliefBISMUTH SUBSALICYLATERITE AID CORPORATIONe3d49cf7-922f-438f-bc62-487a9e4db0252024-10-30WarningsExact identifier
application number: M008
Rite Aid Stomach Relief Original FlavorBISMUTH SUBSALICYLATERITE AID CORPORATION5db6ad20-208e-4881-90fc-672762f70cca2024-10-30WarningsExact identifier
application number: M008
Rite Aid Regular Strngth Pink BismuthBISMUTH SUBSALICYLATERITE AID CORPORATION2c4acea0-dfa2-422d-a13f-17699de747e62024-10-30WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN67006e82-870d-8d63-e053-2991aa0a02d118
211176Pepto-Bismol 525 MG in 30 mL Oral SuspensionPSN67006e82-870d-8d63-e053-2991aa0a02d118
211176bismuth subsalicylate 17.5 MG/ML Oral Suspension [Pepto-bismol]SBD67006e82-870d-8d63-e053-2991aa0a02d118
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD67006e82-870d-8d63-e053-2991aa0a02d118
308762bismuth subsalicylate 1.75 % Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118
211176Pepto-bismol 17.5 MG/ML Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118
211176Pepto-bismol 262 MG per 15 ML Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118
211176Pepto-bismol 525 MG per 30 ML Oral SuspensionSY67006e82-870d-8d63-e053-2991aa0a02d118

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37000-438-0437000043804118 mL in 1 BOTTLE, PLASTIC (37000-438-04) 118 ml2018-03-010000-00-00NoNoCurrent
37000-438-0837000043808236 mL in 1 BOTTLE, PLASTIC (37000-438-08) 236 ml2018-03-010000-00-00NoNoCurrent
37000-438-1237000043812354 mL in 1 BOTTLE, PLASTIC (37000-438-12) 354 ml2018-03-010000-00-00NoNoCurrent
37000-438-1637000043816473 mL in 1 BOTTLE, PLASTIC (37000-438-16) 473 ml2018-03-010000-00-00NoNoCurrent
37000-438-24370000438242 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-24) / 354 mL in 1 BOTTLE, PLASTIC2018-03-010000-00-00NoNoCurrent
37000-438-32370000438322 BOTTLE, PLASTIC in 1 CELLO PACK (37000-438-32) / 473 mL in 1 BOTTLE, PLASTIC2024-06-110000-00-00NoNoCurrent
37000-438-3437000043834100 mL in 1 BOTTLE, PLASTIC (37000-438-34) 100 ml2018-03-010000-00-00NoNoCurrent