Pepto-Bismol

Product NDC
58933-476
11-digit product format
589330476
Labeler code
58933
Product ID
58933-476_40be2dc5-7104-4bc9-e063-6394a90ab398
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET
Route
ORAL
Labeler
Procter & Gamble Manufactura S de RL de CV
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-06-30
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepto-BismolBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV66d9d631-ba73-3ce4-e053-2a91aa0a1cc42025-10-09WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products Do not use if you have an ulcer a bleeding problem bloody or black stool Ask a doctor before use if you have fever mucus in the stool Ask a doctor or pharmacist before use if you are taking any drug for anticoagulation (thinning the blood) diabetes gout arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii62TEY51RR1
Rxcui308760, 702384

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
58933-476-012021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-012021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-022021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-022021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-032021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-032021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-122021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-122021-06-10C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-012021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-012021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-022021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-022021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-032021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-032021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-122021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets
58933-476-122021-01-29C16284748780-1ba0f9c33-55d6-a910-e053-dadaa90a0b85Pepto BISMOL ® Caplets

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-476-01Pepto-Bismol1 in 1 POUCHTABLET19
58933-476-01Pepto-Bismol2 in 1 BLISTER PACKTABLET29
58933-476-02Pepto-Bismol24 in 1 BOTTLETABLET249
58933-476-02Pepto-Bismol1 in 1 CARTONTABLET19
58933-476-03Pepto-Bismol40 in 1 BOTTLETABLET409
58933-476-03Pepto-Bismol1 in 1 CARTONTABLET19
58933-476-12Pepto-Bismol17852 in 1 BAGTABLET178529

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-476PEPTO-BISMOL (BISMUTH SUBSALICYLATE) TABLET [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]8Current NDC, Legacy NDC, 7 package rows20241012_66d9d631-ba73-3ce4-e053-2a91aa0a1cc4.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308760bismuth subsalicylate 262 MG Oral TabletPSN66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
702384Pepto-Bismol 262 MG Oral TabletPSN66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
702384bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]SBD66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
308760bismuth subsalicylate 262 MG Oral TabletSCD66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
702384Pepto-bismol 262 MG Oral TabletSY66d9d631-ba73-3ce4-e053-2a91aa0a1cc49
308760bismuth subsalicylate 262 MG Oral TabletPSN01b318d2-586d-4953-8f98-addc4e3cd4411
702384Pepto-Bismol 262 MG Oral TabletPSN01b318d2-586d-4953-8f98-addc4e3cd4411
702384bismuth subsalicylate 262 MG Oral Tablet [Pepto-bismol]SBD01b318d2-586d-4953-8f98-addc4e3cd4411
308760bismuth subsalicylate 262 MG Oral TabletSCD01b318d2-586d-4953-8f98-addc4e3cd4411
702384Pepto-bismol 262 MG Oral TabletSY01b318d2-586d-4953-8f98-addc4e3cd4411

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58933-476-01589330476011 BLISTER PACK in 1 POUCH (58933-476-01) / 2 TABLET in 1 BLISTER PACK1 blister pack2004-06-300000-00-00NoNoCurrent
58933-476-02589330476021 BOTTLE in 1 CARTON (58933-476-02) / 24 TABLET in 1 BOTTLE1 bottle2004-06-300000-00-00NoNoCurrent
58933-476-03589330476031 BOTTLE in 1 CARTON (58933-476-03) / 40 TABLET in 1 BOTTLE1 bottle2004-06-300000-00-00NoNoCurrent
58933-476-125893304761217852 TABLET in 1 BAG (58933-476-12) 17852 tablet2004-06-300000-00-00NoNoCurrent