FDA.reportPublic FDA data

Pepto-Bismol

Product NDC
37000-438
11-digit product format
370000438
Labeler code
37000
Product ID
37000-438_4dc5d3da-a70c-da7c-e063-6294a90abad2
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

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

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
211176Internal RxNorm lookup
308762Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
67006e82-870d-8d63-e053-2991aa0a02d1Available on FDA.report

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 ®
37000-438-082021-02-11Pepto 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 ®
37000-438-162021-02-11Pepto 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 ®
37000-438-322021-02-11Pepto 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 ®
37000-438-042021-01-29Pepto 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 ®
37000-438-122021-01-29Pepto 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 ®
37000-438-242021-01-29Pepto 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 ®
37000-438-342021-01-29Pepto 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 1 of 12 · 227 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach ReliefBISMUTH SUBSALICYLATEH E B7d721ce3-746f-49aa-916d-eb5a8b3578132026-08-21WarningsExact identifier
application number: M008
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporatione8107300-921c-4ba4-ad6e-f4cf1cd5c2952026-08-20WarningsExact identifier
application number: M008
CVS Health Anti-Diarrheal VanillaBISMUTH SUBSALICYLATECVS Pharmacy,Inc.ce1ed357-228b-452c-9bd4-6b0d20f41c1d2026-08-17WarningsExact identifier
application number: M008
CVS Stomach Relief Ultra StrengthBISMUTH SUBSALICYLATECVS PHARMACYa7fb56c5-9b34-48b8-a355-a16979a0aa7b2026-08-17WarningsExact identifier
application number: M008
regular strength pink bismuthBISMUTH SUBSALICYLATECVS PHARMACY, INC.2b2a1de0-12fa-4800-91e8-f70a405eec722026-08-17WarningsExact identifier
application number: M008
CVS Health Stomach relief Cherry FlavorBISMUTH SUBSALICYLATECVS PHARMACY,INC.c0bb2b6e-8187-495e-8eac-2324fae86cf52026-08-13WarningsExact identifier
application number: M008
CVS Stomach ReliefBISMUTH SUBSALICYLATECVSeb96b2bb-7b2a-4664-96ac-73c917c84c302026-08-13WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECare One (Retail Business Services, LLC.)1af2a7dd-45d7-41a0-af61-4a588f1c19852026-08-12WarningsExact identifier
application number: M008
WinCo FOODS Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODSacf82012-0e40-4d50-b1f1-f36dc3dfad842026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS19c14efc-bf5f-4ef5-a727-aaccfae093f02026-08-07WarningsExact identifier
application number: M008
WinCo FOODS Stomach ReliefBISMUTH SUBSALICYLATEWINCO FOODS LLC53ae695d-f812-462d-9487-8fb5db0aa27d2026-08-07WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
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

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