FDA.reportPublic FDA data

CVS Health Stomach Relief SOFTGEL

Product NDC
51316-829
11-digit product format
513160829
Labeler code
51316
Product ID
51316-829_1acdc9c4-88e5-4165-86a9-a37ba0edeb16
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
CAPSULE, LIQUID FILLED
Route
ORAL
Labeler
CVS Pharmacy, Inc.
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-01-24
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
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
CVS Health Stomach Relief SOFTGEL
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE262 mg/1

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
2121072Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
273013b3-9f79-873d-e063-6394a90a6640Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-829-22CVS Health Stomach Relief SOFTGEL1 in 1 CARTONCAPSULE, LIQUID FILLED12
51316-829-22CVS Health Stomach Relief SOFTGEL12 in 1 BLISTER PACKCAPSULE, LIQUID FILLED122

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
51316-829CVS HEALTH STOMACH RELIEF SOFTGEL (BISMUTH SUBSALICYLATE) CAPSULE, LIQUID FILLED [CVS PHARMACY, INC.]2Current NDC, 2 package rows20250129_273013b3-9f79-873d-e063-6394a90a6640.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
2121072bismuth subsalicylate 262 MG Oral CapsulePSN273013b3-9f79-873d-e063-6394a90a66402
2121072bismuth subsalicylate 262 MG Oral CapsuleSCD273013b3-9f79-873d-e063-6394a90a66402

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51316-829-22513160829221 BLISTER PACK in 1 CARTON (51316-829-22) / 12 CAPSULE, LIQUID FILLED in 1 BLISTER PACK1 blister pack2025-01-24NoNoCurrent