FDA.reportPublic FDA data

Stomach Relief

Product NDC
70000-0591
11-digit product format
700000591
Labeler code
70000
Product ID
70000-0591_227d63ba-9ab8-4895-9ba1-7b3c9e2100d3
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
TABLET, CHEWABLE
Route
ORAL
Labeler
CARDINAL HEALTH 110, LLC. DBA LEADER
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-10-05
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
Stomach Relief
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
308761Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b38d815b-a249-46d1-a9d0-4e8efab3e56bAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0591-1Stomach Relief5 in 1 BOXTABLET, CHEWABLE55
70000-0591-1Stomach Relief6 in 1 BLISTER PACKTABLET, CHEWABLE65
70000-0591-2Stomach Relief8 in 1 BOXTABLET, CHEWABLE85
70000-0591-2Stomach Relief6 in 1 BLISTER PACKTABLET, CHEWABLE65

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0591-1EA - Each70000-05913b7345f1-f49c-4639-8597-9018d939e08b12022-02-07
70000-0591-2EA - Each70000-05917a5ba331-0ca8-45df-b5d7-4dcf92d0fb6e12022-02-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0591STOMACH RELIEF (BISMUTH SUBSALICYLATE) TABLET, CHEWABLE [CARDINAL HEALTH 110, LLC. DBA LEADER]5Current NDC, Legacy NDC, 4 package rows20250108_b38d815b-a249-46d1-a9d0-4e8efab3e56b.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 10 · 198 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medique Diotame InstydoseBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b214128-6980-0f84-e063-6294a90ad8ca2026-09-10WarningsExact identifier
application number: M008
Regular Strength Pink BismuthBISMUTH SUBSALICYLATERaritan Pharmaceuticals Inc89d18117-f0af-408a-a5ae-19da841588062026-09-09WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.a03fabe0-4839-480e-8890-278e573cf4cc2026-09-09WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.5fa794f9-440c-479c-961c-34d298bb532b2026-09-09WarningsExact identifier
application number: M008
DRx Choice Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERARITAN PHAMACEUTICALS INC75e8cd49-850f-4816-b350-ce76601ebfc02026-09-09WarningsExact identifier
application number: M008
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporation90b0c541-2834-4ed7-9d01-76080dd730572026-09-09WarningsExact identifier
application number: M008
Pepto Bismol Fast Melts Fresh Berry FlavoredBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company039391d0-9ec1-45a3-84fa-b5f591794e412026-09-08WarningsExact identifier
application number: M008
Kroger Regular Strength Pink BismuthBISMUTH SUBSALICYLATEKROGER COMPANY97175691-4881-450d-a14c-3413ab47a3ca2026-09-02WarningsExact identifier
application number: M008
Kroger Stomach ReliefBISMUTH SUBSALICYLATEKROGER COMPANY4963f568-9d8d-4ad0-b840-bed3f6f9cb7b2026-09-01WarningsExact identifier
application number: M008
Ultra Strength digestive reliefBISMUTH SUBSALICYLATETHE KROGER CO.5e288108-1578-4379-a3d6-44b4471876432026-09-01WarningsExact identifier
application number: M008
Kroger Digestive ReliefBISMUTH SUBSALICYLATEKROGER COMPANY2b32bee7-154a-4e5b-a811-066d1e6c5dcb2026-09-01WarningsExact identifier
application number: M008
Regular Strength Stomach ReliefBISMUTH SUBSALICYLATEWalmart Inc.50a88db4-633d-d3bc-e063-6294a90a18c52026-08-29WarningsExact identifier
application number: M008
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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308761bismuth subsalicylate 262 MG Chewable TabletPSNb38d815b-a249-46d1-a9d0-4e8efab3e56b5
308761bismuth subsalicylate 262 MG Chewable TabletSCDb38d815b-a249-46d1-a9d0-4e8efab3e56b5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70000-0591-1700000591015 BLISTER PACK in 1 BOX (70000-0591-1) / 6 TABLET, CHEWABLE in 1 BLISTER PACK5 blister pack2021-10-050000-00-00NoNoCurrent
70000-0591-2700000591028 BLISTER PACK in 1 BOX (70000-0591-2) / 6 TABLET, CHEWABLE in 1 BLISTER PACK8 blister pack2021-10-050000-00-00NoNoCurrent