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 7 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Revasol Peptic ReliefBISMUTH SUBSALICYLATERnv LLC30dc3a0a-3496-4bdf-e063-6394a90a62fd2025-03-21WarningsExact identifier
application number: M008
TopCare Bismuth Stomach ReliefBISMUTHTopCo308f4b2a-22ff-42b9-e063-6394a90acc752025-03-17WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Company25175eac-d15f-ce0d-e063-6394a90a06502025-03-10WarningsExact identifier
application number: M008
Pink Bismuth Regular StrengthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0c675e-72ce-4a22-e063-6394a90a3dff2025-02-27WarningsExact identifier
application number: M008
Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0ce5dd-9eb5-8568-e063-6394a90a1a292025-02-27WarningsExact identifier
application number: M008
Maximum Strength Pink BismuthBISMUTH SUBSALICYLATEDiscount Drug Mart, Inc2e0d4508-e5a1-ba46-e063-6394a90aec2a2025-02-27WarningsExact identifier
application number: M008
Pink Bismuth OriginalBISMUTH SUBSALICYLATE 525 MGDiscount Drug Mart, Inc2e0cb7d7-4c4f-824a-e063-6394a90aa3a42025-02-27WarningsExact identifier
application number: M008
SIMETHICONESIMETHICONENuCare Pharmaceuticals,Inc.e07f6acc-1b75-d8eb-e053-2a95a90a7d9b2025-02-24WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c51458b-869c-0283-e063-6394a90a4ff72025-02-12WarningsExact identifier
application number: M008
Max Strength Stomach ReliefBISMUTH SUBSALICYLATEHarris Teeter, LLC2c516139-0a6a-5ba6-e063-6394a90aa14a2025-02-12WarningsExact identifier
application number: M008
Bismuth SubsalicylateBISMUTH SUBSALICYLATELEADER/ Cardinal Health 110, Inc.d4af6694-910c-da17-e053-2995a90a84542025-02-11WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEDOLGENCORP, INC.f2ec112f-213c-8a23-e053-2995a90a5f3f2025-02-10WarningsExact identifier
application number: M008
Maximum Strength Stomach ReliefBISMUTH SUBSALICYLATEGuardian Drug Companyaf899b52-7d8c-4485-9fb8-006dae53568a2025-02-10WarningsExact identifier
application number: M008
CVS Health Stomach Relief SOFTGELBISMUTH SUBSALICYLATECVS Pharmacy, Inc.273013b3-9f79-873d-e063-6394a90a66402025-01-24WarningsExact identifier
application number: M008
GNP Pink BismuthBISMUTH SUBSALICYLATEAmerisource Bergen9f5df648-298a-43e3-b250-8db6786fc93f2025-01-20WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEReliable 1 Laboratories LLC2e40ffd8-1afa-43af-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M008
Equate Stomach ReliefBISMUTH SUBSALICYLATEWal-Mart Stores, Inc.1e8ae968-6d40-4ac7-9bce-01d086584b612025-01-09WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADERb38d815b-a249-46d1-a9d0-4e8efab3e56b2025-01-06WarningsExact identifier
application number: M008
Quality Choice Stomach Relief 528BISMUTH SUBSALICYLATEChain Drug Marketing Association Inc.e065320d-09ee-4ab8-868a-ab3b4239e3922025-01-03WarningsExact identifier
application number: M008
HEB Stomach ReliefBISMUTH SUBSALICYLATEH E Bfac642cf-f2f7-4857-b54f-82f1dcb400ab2024-12-26WarningsExact 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