FDA.reportPublic FDA data

SIGNATURE CARE

Product NDC
21130-193
11-digit product format
211300193
Labeler code
21130
Product ID
21130-193_4b54fa21-d8ea-4497-aa32-17e47669c8e1
Type
HUMAN OTC DRUG
Nonproprietary name
Bismuth subsalicylate
Dosage form
SUSPENSION
Route
ORAL
Labeler
SAFEWAY
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-02-02
Substance
BISMUTH SUBSALICYLATE
Active strength
525 mg/15mL
Pharmacologic classes
Bismuth [CS], Bismuth [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
SIGNATURE CARE
Brand name suffix
Ultra Strength Stomach
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BISMUTH SUBSALICYLATE525 mg/15mL

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
308763Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4b54fa21-d8ea-4497-aa32-17e47669c8e1Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-193-12SIGNATURE CAREUltra Strength Stomach354 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 1 of 12 · 228 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp212ccf1f-faaf-4f77-9722-28713fc427612026-08-05WarningsExact identifier
application number: M008
nexmed multi symptom stomach reliefBISMUTH SUBSALICYLATE 262 MGShield Pharmaceuticals Corp7c0ca713-643a-46bd-9d9a-21ac39c808c42026-08-05WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEShield Pharmaceuticals Corp8177318d-427b-4bfc-9d7f-51d1545f4eb82026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companybb8d2ed8-54a2-2295-e053-2995a90a10ac2026-07-27WarningsExact identifier
application number: M008
Pepto Bismol ChewsBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companycfe9214d-25e9-7729-e053-2a95a90a0dfb2026-07-27WarningsExact identifier
application number: M008
Pepto BismolBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company252b143f-eee8-f407-e063-6394a90a0a082026-07-27WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
application number: M008
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)d20af4fb-d579-4d1e-86ae-342933f4de752026-07-15WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWALMART INC. (see also Equate)369fe912-dd0e-4ff3-a597-5ee81332838a2026-07-15WarningsExact identifier
application number: M008
Stomach Relief UltraBISMUTH SUBSALICYLATEEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)642c14bd-be99-410b-9ba7-6e71c97052302026-07-15WarningsExact identifier
application number: M008
Good Neighbor Ultra Strength Stomach ReliefBISMUTH SUBSALICYLATEAMERISOURCE BERGEN71c30b10-db24-4a42-a4f4-db552e3d5fe62026-07-13WarningsExact identifier
application number: M008
Pepto Bismol CHEWABLESBISMUTH SUBSALICYLATESelect Consumer Group5611c6cb-5c0b-cf4e-e063-6394a90abff82026-07-07WarningsExact identifier
application number: M008
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERugby Laboratories6166c04e-20c6-4678-b16d-5174744456982026-06-26WarningsExact identifier
application number: M008
SootheBISMUTH SUBSALICYLATEWalgreens394e16b8-dd7c-4c68-86ce-3623936745a72026-06-25WarningsExact identifier
application number: M008
Stomach Relief regular strengthBISMUTH SUBSALICYLATECVS Pharmacy1aa386ac-8ffd-4ba4-9b2e-19156d374c482026-06-25WarningsExact identifier
application number: M008
Stomach ReliefBISMUTH SUBSALICYLATEWalgreensc367d913-e37b-467a-84da-dd6a22c793ae2026-06-25WarningsExact identifier
application number: M008
Bismuth Subsalicylate Pink BismuthBISMUTH SUBSALICYLATEHyvee Inc4e575573-9ded-bfbf-e063-6394a90aed3b2026-06-23WarningsExact identifier
application number: M008
Stomach relieverBISMUTH SUBSALICYLATEHyvee Inc44ead6e1-cd88-4602-e063-6394a90aed9f2026-06-16WarningsExact identifier
application number: M008
Bismuth Subsalicylate 262 mgBISMUTH SUBSALICYLATEPreferred Pharmaceuticals Inc.f7627bf1-da97-4875-b614-5029663f74822026-06-08WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308763bismuth subsalicylate 1050 MG in 30 mL Oral SuspensionPSN4b54fa21-d8ea-4497-aa32-17e47669c8e11
308763bismuth subsalicylate 35 MG/ML Oral SuspensionSCD4b54fa21-d8ea-4497-aa32-17e47669c8e11
308763bismuth subsalicylate 1050 MG per 30 ML Oral SuspensionSY4b54fa21-d8ea-4497-aa32-17e47669c8e11
308763bismuth subsalicylate 525 MG per 15 ML Oral SuspensionSY4b54fa21-d8ea-4497-aa32-17e47669c8e11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
21130-193-1221130019312354 mL in 1 BOTTLE (21130-193-12) 354 ml2026-02-02NoNoCurrent