FDA.reportPublic FDA data

Pepto Bismol

Product NDC
58933-011
11-digit product format
589330011
Labeler code
58933
Product ID
58933-011_5d1b6184-6707-e2e5-e063-6394a90abdec
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth Subsalicylate
Dosage form
TABLET, CHEWABLE
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
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
CHEWABLES
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
75d4bef7-334c-4a95-abb5-bff9def24114Product name220260112
1e73f975-1ce7-705e-2bcf-788b1b5e24baProduct name520251124
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
7dea7767-9f52-b60a-5435-33cb9cc28baeProduct name420250124
6338270f-96cb-0ecb-6fbb-0a9bc78001f4Product name720250116
11939cf5-0ea7-5df5-5127-00a7ce07fd7fProduct name520250115
0ca83774-3f79-b837-5d6f-c210102f3bc8Product name620250114
88300afc-e1c4-ad17-c80b-4957f1b809a5Product name520250113
10f838ef-a72b-645d-80f8-e2255205c3b1Product name620240805
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
4eddd6ca-259a-4c6c-a3a4-2025015ce043Product name720240611
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
16cde546-8deb-4df2-a072-dab5566ede95Product name120231003
20ab58de-c64a-4ec2-9210-3aa3fae2b66fProduct name120230808
f6d1b8d7-3bd1-4248-eddd-b60565c88015Product name420230808
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
a3631b20-02d1-41d7-8187-5e5e850b9e80Product name120230306
79e1734e-f721-4d46-978a-be382f771672Product name220230110
874f4e63-49d2-5150-5d77-052172814ebdProduct name620230105
ac6963c4-31c6-325f-ee58-83a0a06597adProduct name520221206
41b814f3-0166-1c53-c9ef-a0794c7daf9dProduct name320221110
a590be26-846c-8659-a5a1-fb25907965dcProduct name220221110
06cc817f-60e0-4473-8e6b-c44d11dc5af6Product name920220921
92ead9ae-674d-4eee-a492-c385d496891fProduct name320220308
d7724692-1155-4cc8-a415-22f5fc4aec35Product name620220216
a62a50ac-1535-4461-9768-8ae703e2e9fbProduct name120210525
bde672ba-4805-28d0-1986-73543d41b412Product name220210201
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
103b151b-b17f-42ac-8624-3ef62f5e2975Product name220200507
b8497372-efe9-9dde-fa2d-59be9761aa64Product name920200428
20c8cafe-5cfc-44f8-a9be-a664f437f780Product name220200225
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
3a16d77a-e865-468a-aedf-6e58913c1c21Product name320190619
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
2a0c98e1-033f-4e0d-a0da-b5291ffbe880Product name120190320
00d531e4-b130-8c52-eaf9-826cbb6f15ddProduct name320190205
aa0f353d-f35e-62e4-4e1f-5b563f01c659Product name920190205
22d922aa-c443-d9f3-b23c-03b03a9ad31cProduct name720181220
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
377068df-225f-7318-a910-a1987cdfa361Product name320170608
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
f212291f-05fe-9603-fc7e-bd73e38ce1e6Product name220161129
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
557673c2-8256-b351-e863-4ec71a5a64b0Product name220160714
dbc9a339-6215-4e94-9546-57a3b34902ceProduct name120160517
182f9ab4-4ab5-c449-200f-87ce2ce8e550Product name220151105
9425d234-4ae1-4b53-adc6-8cc7af6dd657Product name120150929
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
23475c0b-a5b5-4fec-b97f-acca901eae6aProduct name120140718
105ef617-6fa4-6713-326f-72ec8a6b75a9Product name120140508
2a21311a-89e2-0e83-2ebd-117f9798b2b2Product name120140508
332e86c3-7875-ca6e-f934-2206d2b31996Product name120140508
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508
3ed6b849-48b8-8899-c288-6eeb396123b6Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
47fd879b-91c5-e1e5-130f-29d082a871ecProduct name120140508
53855190-7124-8179-f018-e792f7c27f28Product name120140508
61c18d4e-b552-5478-8fc0-df38b93e3100Product name120140508
7b2938c9-7eb7-e312-ae90-f54f4240361eProduct name120140508
7dfac40f-a405-cd2e-7c06-3059ec0e1092Product name120140508
84fb0b3d-1d72-b672-bc70-2b676a23e7e0Product name120140508
865c72dd-0d94-daac-f728-ddd4ded2a79eProduct name120140508
9007e8a7-ff50-f9b9-7945-f2a1deadd94eProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508
96c2be53-8e44-452d-56a2-d255b2f1af2dProduct name120140508
96c5169b-5b9d-547d-bf22-d688d91866e4Product name120140508
997601aa-bb5f-6971-6b90-a21132c12c7bProduct name120140508
b8e0daf1-fb81-290b-c0bf-873be19ef775Product name120140508
bc07ef78-e82d-0c19-31f4-31f263780582Product name120140508
bf8bd5f7-495f-4022-2780-7ded7ea7ea44Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58933-011-02Pepto BismolCHEWABLES2 in 1 PACKETTABLET, CHEWABLE24
58933-011-04Pepto BismolCHEWABLES4 in 1 PACKETTABLET, CHEWABLE44
58933-011-12Pepto BismolCHEWABLES6 in 1 BLISTER PACKTABLET, CHEWABLE64
58933-011-12Pepto BismolCHEWABLES2 in 1 CARTONTABLET, CHEWABLE24
58933-011-30Pepto BismolCHEWABLES6 in 1 BLISTER PACKTABLET, CHEWABLE64
58933-011-30Pepto BismolCHEWABLES5 in 1 CARTONTABLET, CHEWABLE54
58933-011-48Pepto BismolCHEWABLES8 in 1 CARTONTABLET, CHEWABLE84
58933-011-48Pepto BismolCHEWABLES6 in 1 BLISTER PACKTABLET, CHEWABLE64
58933-011-90Pepto BismolCHEWABLES3 in 1 BLISTER PACKTABLET, CHEWABLE34
58933-011-90Pepto BismolCHEWABLES5 in 1 CARTONTABLET, CHEWABLE54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58933-011PEPTO BISMOL CHEWABLES (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [PROCTER & GAMBLE MANUFACTURA S DE RL DE CV]3Current NDC, 10 package rows20241012_06fce961-5e57-b640-e063-6394a90a9e8a.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 6 of 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATECARDINAL HEALTH 110, LLC. DBA LEADER7d6047a9-5557-487a-ae06-f904dac626c92025-10-14WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEAtlantic Biologicals Corp401f8393-680c-e1a8-e063-6394a90a81ab2025-10-01WarningsExact identifier
application number: M008
First Aid Direct Peptum TabsBISMUTH SUBSALICYLATECintas Corpdd14cd57-3f7c-4634-9da9-6f83dc5bae122025-09-29WarningsExact identifier
application number: M008
RIGHT REMEDIES Stomach Relief BISMUTH SUBSALICYLATE 262 mg softgelBISMUTH SUBSALICYLATEStrive Pharmaceuticals Inc.0f271054-fa96-4475-8279-65f4565aba362025-09-22WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEFSA Store Inc. (Caring Mill)fbabc313-600a-4722-9948-1a3e214140592025-09-18WarningsExact identifier
application number: M008
QUALITY CHOICE ULTRA STRENGTH STOMACH RELIEFBISMUTH SUBSALICYLATEQUALITY CHOICE (CHAIN DRUG MARKETING ASSOCIATION)67c610b1-fe94-4ad3-ad1a-8bd93a4da9d92025-09-11WarningsExact identifier
application number: M008
Medique DiotameBISMUTH SUBSALICYLATEUnifirst First Aid Corporation0667ec26-c2cd-153c-e054-00144ff88e882025-09-08WarningsExact identifier
application number: M008
McKesson BismuthBISMUTH SUBSALICYLATEMcKesson Medical-Surgicald1f3dfa4-e021-6384-e053-2995a90a7b422025-09-08WarningsExact identifier
application number: M008
Medi-First Pep-T-MedBISMUTH SUBSALICYLATEUnifirst First Aid Corporation88f4d5d4-92ed-40ab-97a9-181da72f869b2025-09-08WarningsExact identifier
application number: M008
Thompson Chewable Bismuth TabsBISMUTH SUBSALICYLATEThompson Safety LLCc94b9bc2-b764-a9a7-e053-2a95a90aed812025-09-08WarningsExact identifier
application number: M008
Goodsense Regular strength Stomach Relief 122BISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f0588ab8-d1fc-419a-8d68-bee42332d50f2025-08-01WarningsExact identifier
application number: M008
Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338ca589-91ff-30ed-e063-6294a90a243a2025-07-21WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATE 525 MGRetail Business Services, LLC.338d61af-35a8-fba7-e063-6294a90a38e82025-07-21WarningsExact identifier
application number: M008
SennaSENNOSIDESMajor Pharmaceuticalscfb6bf89-c77e-4372-9bc9-44d6a659c9552025-07-18WarningsExact identifier
application number: M008
Major Bismuth SubsalicylateBISMUTH SUBSALICYLATEMajor Pharmaceuticals2a7c9cc1-206e-4018-b89d-7b634df43df62025-07-11WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55440401-f82f-45a3-ba7e-6ccdfdacead32025-07-10WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGPioneer Life Sciences, LLC07e2cc82-ab0e-46c5-863b-67658b6126782025-06-27WarningsExact identifier
application number: M008
Upset Stomach Relief-Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATE 262 MGNUVICARE LLC6697e464-00ac-41de-a7ea-d7bb24ed5e2a2025-06-25WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEP & L Development, LLC8383945f-b3a7-4242-bfaa-acf24b66406d2025-05-30WarningsExact identifier
application number: M008
5-Symptom Digestive ReliefBISMUTH SUBSALICYLATETARGET CORPORATION28fba615-48ca-8d96-e063-6394a90a27972025-04-12WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSN033bccc6-6e81-487f-91fe-9d7cc465e1b24
308761bismuth subsalicylate 262 MG Chewable TabletPSN06fce961-5e57-b640-e063-6394a90a9e8a4
211151Pepto-Bismol 262 MG Chewable TabletPSN033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol 262 MG Chewable TabletPSN06fce961-5e57-b640-e063-6394a90a9e8a4
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD06fce961-5e57-b640-e063-6394a90a9e8a4
308761bismuth subsalicylate 262 MG Chewable TabletSCD033bccc6-6e81-487f-91fe-9d7cc465e1b24
308761bismuth subsalicylate 262 MG Chewable TabletSCD06fce961-5e57-b640-e063-6394a90a9e8a4
211151Pepto-bismol 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-bismol 262 MG Chewable TabletSY06fce961-5e57-b640-e063-6394a90a9e8a4
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY06fce961-5e57-b640-e063-6394a90a9e8a4
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY033bccc6-6e81-487f-91fe-9d7cc465e1b24
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY06fce961-5e57-b640-e063-6394a90a9e8a4
313782acetaminophen 325 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
153008Advil 200 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1536680Alka-Seltzer 325 MG / 1000 MG / 1916 MG Effervescent Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
212033aspirin 325 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
308761bismuth subsalicylate 262 MG Chewable TabletPSNd9ce1f32-7e18-471a-adb6-5992c59602f61
308761bismuth subsalicylate 262 MG Chewable TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
313884calcium carbonate 420 MG (Ca 168 MG) Chewable TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
978012Diamode 2 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1049630diphenhydrAMINE HCl 25 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
310965ibuprofen 200 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
978010loperamide HCl 2 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1020126Loradamed 10 MG 24HR Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG 24HR Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
995666meclizine HCl 25 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
211151Pepto-Bismol 262 MG Chewable TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
211151Pepto-Bismol 262 MG Chewable TabletPSNd9ce1f32-7e18-471a-adb6-5992c59602f61
1049182phenylephrine HCl 10 MG Oral TabletPSN4feee16b-43be-bb71-e063-6394a90af9591
1536680aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SBD4feee16b-43be-bb71-e063-6394a90af9591
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBD4feee16b-43be-bb71-e063-6394a90af9591
211151bismuth subsalicylate 262 MG Chewable Tablet [Pepto-bismol]SBDd9ce1f32-7e18-471a-adb6-5992c59602f61
153008ibuprofen 200 MG Oral Tablet [Advil]SBD4feee16b-43be-bb71-e063-6394a90af9591
978012loperamide hydrochloride 2 MG Oral Tablet [Diamode]SBD4feee16b-43be-bb71-e063-6394a90af9591
1020126loratadine 10 MG Oral Tablet [Loradamed]SBD4feee16b-43be-bb71-e063-6394a90af9591
313782acetaminophen 325 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
1536675aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG Effervescent Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
212033aspirin 325 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
308761bismuth subsalicylate 262 MG Chewable TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
308761bismuth subsalicylate 262 MG Chewable TabletSCDd9ce1f32-7e18-471a-adb6-5992c59602f61
313884calcium carbonate 420 MG Chewable TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
1049630diphenhydramine hydrochloride 25 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
310965ibuprofen 200 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
978010loperamide hydrochloride 2 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
995666meclizine hydrochloride 25 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
1049182phenylephrine hydrochloride 10 MG Oral TabletSCD4feee16b-43be-bb71-e063-6394a90af9591
153008Advil 200 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1536680Alka-Seltzer (aspirin 325 MG / citric acid 1000 MG / sodium bicarbonate 1916 MG) Effervescent Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
313782APAP 325 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1536675ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1536680ASA 325 MG / Citric Acid 1000 MG / NaHCO3 1916 MG Effervescent Oral Tablet [Alka-Seltzer]SY4feee16b-43be-bb71-e063-6394a90af9591
212033ASA 325 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
313884calcium carbonate 420 MG (calcium 168 MG) Chewable TabletSY4feee16b-43be-bb71-e063-6394a90af9591
978012Diamode 2 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
310965ibuprofen 200 MG (as ibuprofen sodium 256 MG) Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
1020126Loradamed 10 MG Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
311372loratadine 10 MG 24 HR Oral TabletSY4feee16b-43be-bb71-e063-6394a90af9591
211151Pepto-bismol 262 MG Chewable TabletSY4feee16b-43be-bb71-e063-6394a90af9591
211151Pepto-bismol 262 MG Chewable TabletSYd9ce1f32-7e18-471a-adb6-5992c59602f61
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSY4feee16b-43be-bb71-e063-6394a90af9591
211151Pepto-Bismol InstaCool 262 MG Chewable TabletSYd9ce1f32-7e18-471a-adb6-5992c59602f61
211151Pepto-Bismol To-Go 262 MG Chewable TabletSYd9ce1f32-7e18-471a-adb6-5992c59602f61
211151Pepto-Bismol To-Go 262 MG Chewable TabletSY4feee16b-43be-bb71-e063-6394a90af9591

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58933-011-02589330011022 TABLET, CHEWABLE in 1 PACKET (58933-011-02) 2004-06-30NoNoCurrent
58933-011-04589330011044 TABLET, CHEWABLE in 1 PACKET (58933-011-04) 2004-06-30NoNoCurrent
58933-011-12589330011122 BLISTER PACK in 1 CARTON (58933-011-12) / 6 TABLET, CHEWABLE in 1 BLISTER PACK2 blister pack2004-06-30NoNoCurrent
58933-011-30589330011305 BLISTER PACK in 1 CARTON (58933-011-30) / 6 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2004-06-30NoNoCurrent
58933-011-48589330011488 BLISTER PACK in 1 CARTON (58933-011-48) / 6 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2004-06-30NoNoCurrent
58933-011-90589330011903 CARTON in 1 BLISTER PACK (58933-011-90) / 5 BLISTER PACK in 1 CARTON / 6 TABLET, CHEWABLE in 1 BLISTER PACK3 carton2022-10-04NoNoCurrent