FDA.reportPublic FDA data

Dr. Simi Stomach Relief

Product NDC
85786-802
11-digit product format
857860802
Labeler code
85786
Product ID
85786-802_4dc9233e-68fc-e1e8-e063-6294a90aee33
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE 525 MG
Dosage form
SUSPENSION
Route
ORAL
Labeler
Farmacias De Similares TX LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-03-24
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/30mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
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
Dr. Simi Stomach Relief
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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
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
4dc9233e-68fb-e1e8-e063-6294a90aee33Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85786-802-12Dr. Simi Stomach Relief354 mL in 1 BOTTLESUSPENSION3541

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 12 · 223 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pepto Bismol Fast Melts Winter Frost FlavoredBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company88a3315f-479c-400c-9440-4e7152044a492025-10-03WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV06fce961-5e57-b640-e063-6394a90a9e8a2025-10-01WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATEProcter & Gamble Manufactura S de RL de CV06fc9cc7-eddd-62be-e063-6294a90aa1752025-10-01WarningsExact 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
Stomach Relief Original StrengthBISMUTH SUBSALICYLATECardinal Health (Leader) 70000f1cbacb3-824b-4089-9da1-c4cf4bd27b992025-08-06WarningsExact 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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308762bismuth subsalicylate 525 MG in 30 mL Oral SuspensionPSN4dc9233e-68fb-e1e8-e063-6294a90aee331
308762bismuth subsalicylate 17.5 MG/ML Oral SuspensionSCD4dc9233e-68fb-e1e8-e063-6294a90aee331
308762bismuth subsalicylate 1.75 % Oral SuspensionSY4dc9233e-68fb-e1e8-e063-6294a90aee331
308762bismuth subsalicylate 262 MG per 15 ML Oral SuspensionSY4dc9233e-68fb-e1e8-e063-6294a90aee331
308762bismuth subsalicylate 524 MG per 30 ML Oral SuspensionSY4dc9233e-68fb-e1e8-e063-6294a90aee331
308762bismuth subsalicylate 525 MG per 30 ML Oral SuspensionSY4dc9233e-68fb-e1e8-e063-6294a90aee331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
85786-802-1285786080212354 mL in 1 BOTTLE (85786-802-12) 354 ml2026-03-24NoNoCurrent