FDA.reportPublic FDA data

Estomaquil Polvo

Product NDC
58988-1080
Requested package NDC
58988-1080-3
11-digit product format
589881080
Labeler code
58988
Product ID
58988-1080_b60909fc-e262-4ad4-bb96-e09b71b38e1c
Type
HUMAN OTC DRUG
Nonproprietary name
BISMUTH SUBSALICYLATE
Dosage form
POWDER
Route
ORAL
Labeler
ProMex LLC
Application
M008
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2004-01-02
Substance
BISMUTH SUBSALICYLATE
Active strength
262 mg/1
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Estomaquil Polvo
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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1721449Internal RxNorm lookup
1721455Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
cf94c99a-c489-45ec-bb13-3e6959e377deAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
58988-1080-12023-12-01Estomaquil ® Polvo
58988-1080-22023-12-01Estomaquil ® Polvo
58988-1080-32023-12-01Estomaquil ® Polvo
58988-1080-12023-07-28Estomaquil ® Polvo
58988-1080-22023-07-28Estomaquil ® Polvo
58988-1080-32023-07-28Estomaquil ® Polvo
58988-1080-12022-01-30Estomaquil ® Polvo
58988-1080-22022-01-30Estomaquil ® Polvo
58988-1080-32022-01-30Estomaquil ® Polvo
58988-1080-12022-01-28Estomaquil ® Polvo
58988-1080-22022-01-28Estomaquil ® Polvo
58988-1080-32022-01-28Estomaquil ® Polvo

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58988-1080-1Estomaquil Polvo10 in 1 CARTONPOWDER104
58988-1080-1Estomaquil Polvo1 in 1 POUCHPOWDER14
58988-1080-2Estomaquil Polvo20 in 1 CARTONPOWDER204
58988-1080-2Estomaquil Polvo1 in 1 POUCHPOWDER14
58988-1080-3Estomaquil Polvo50 in 1 CARTONPOWDER504
58988-1080-3Estomaquil Polvo1 in 1 POUCHPOWDER14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BISMUTH SUBSALICYLATEACTIVE INGREDIENT62TEY51RR1ESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGKESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1
CITRIC ACID MONOHYDRATEINACTIVE INGREDIENT2968PHW8QPESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1
MAGNESIUM HYDROXIDEINACTIVE INGREDIENTNBZ3QY004SESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QOESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1
TARTARIC ACIDINACTIVE INGREDIENTW4888I119HESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58988-1080ESTOMAQUIL POLVO (BISMUTH SUBSALICYLATE) POWDER [PROMEX LLC]4Current NDC, Legacy NDC, 6 package rows20231202_cf94c99a-c489-45ec-bb13-3e6959e377de.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 12 · 226 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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
KaopectateBISMUTH SUBSALICYLATEKramer Laboratories3877a88d-9546-48ce-ad6b-3c2a115e3eaf2026-06-03WarningsExact identifier
application number: M008
Bismuth Subsalicylate Suspension Regular StrengthBISMUTH SUBSALICYLATEAptaPharma Inc.f0976d6c-d574-49e8-b98a-23a660d83fa02026-06-02WarningsExact identifier
application number: M008

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1721449bismuth subsalicylate 262 MG Powder for Oral SuspensionPSNcf94c99a-c489-45ec-bb13-3e6959e377de4
1721455Estomaquil 262 MG Powder for Oral SuspensionPSNcf94c99a-c489-45ec-bb13-3e6959e377de4
1721455bismuth subsalicylate 262 MG Powder for Oral Suspension [Estomaquil]SBDcf94c99a-c489-45ec-bb13-3e6959e377de4
1721449bismuth subsalicylate 262 MG Powder for Oral SuspensionSCDcf94c99a-c489-45ec-bb13-3e6959e377de4
1721455Estomaquil 262 MG Powder for Oral SuspensionSYcf94c99a-c489-45ec-bb13-3e6959e377de4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
58988-1080-35898810800350 POUCH in 1 CARTON (58988-1080-3) / 1 POWDER in 1 POUCH50 pouch2004-01-020000-00-00NoNoCurrent