FDA.reportPublic FDA data

NDC 58988-1080-01 - Estomaquil Polvo

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
58988-1080
Requested NDC
58988-1080-01
Package NDCs from labels
58988-1080-1, 58988-1080-2, 58988-1080-3, 58988-1080-01
Manufacturer
ProMex LLC
Effective date
2023-11-29
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Estomaquil Polvo - ProMex LLCProMex LLC2023-11-29HUMAN OTC DRUG LABEL

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 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

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

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 99 · 1,972 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Lymph Tonic IIECHINACEA (ANGUSTIFOLIA), COLLINSONIA CANADENSIS, PHYTOLACCA DECANDRA, KALI IODATUM, PINUS SYLVESTRIS, PIX LIQUIDA, FERRUM PHOSPHORICUM, AESCULUS HIPPOCASTANUM, BARYTA CARBONICA, BERBERIS VULGARIS, CALCAREA CARBONICA, CALCAREA PHOSPHORICA, CAUSTICUM, HEPAR SULPHURIS CALCAREUM, KREOSOTUM, LYCOPODIUM CLAVATUM, MERCURIUS SOLUBILIS, NATRUM MURIATICUM, NITRICUM ACIDUM, PHOSPHORUS, PULSATILLA (PRATENSIS), SILICEA, STELLARIA MEDIA, SULPHUR, TEREBINTHINA, THUJA OCCIDENTALIS, BUFO RANABioActive Nutritional, Inc.0e3265b0-b210-4a4c-80d2-8a9712981d4e2026-09-17WarningsExact identifier
unii: ETJ7Z6XBU4
Medique Diotame InstydoseBISMUTH SUBSALICYLATEUnifirst First Aid Corporation5b214128-6980-0f84-e063-6294a90ad8ca2026-09-10WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Regular Strength Pink BismuthBISMUTH SUBSALICYLATERaritan Pharmaceuticals Inc89d18117-f0af-408a-a5ae-19da841588062026-09-09WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Childrens Stomach ReliefCALCIUM CARBONATEWal-Mart Stores Inc7471ec99-6c0b-40d8-a9cf-85240a0d471a2026-09-09WarningsExact identifier
unii: H0G9379FGK
Pepto Bismol UltraBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Companyd800eb8c-42c8-fb12-e053-2a95a90af2a22026-09-09WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.a03fabe0-4839-480e-8890-278e573cf4cc2026-09-09WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Stomach Relief Regular StrengthBISMUTH SUBSALICYLATEThe Kroger Co.5fa794f9-440c-479c-961c-34d298bb532b2026-09-09WarningsExact identifier
application number: M008
unii: 62TEY51RR1
DRx Choice Stomach Relief Regular StrengthBISMUTH SUBSALICYLATERARITAN PHAMACEUTICALS INC75e8cd49-850f-4816-b350-ce76601ebfc02026-09-09WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Digestive Relief Regular StrengthBISMUTH SUBSALICYLATETARGET Corporation90b0c541-2834-4ed7-9d01-76080dd730572026-09-09WarningsExact identifier
application number: M008
unii: 62TEY51RR1
COMPLETE ACID REDUCERFAMOTIDINE, CALCIUM CARBONATE, MAGNESIUM HYDROXIDECVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATEDb023cd92-eabb-474b-9b5a-4b46cf48256b2026-09-08WarningsExact identifier
unii: NBZ3QY004S
unii: H0G9379FGK
Pepto Bismol Fast Melts Fresh Berry FlavoredBISMUTH SUBSALICYLATEThe Procter & Gamble Manufacturing Company039391d0-9ec1-45a3-84fa-b5f591794e412026-09-08WarningsExact identifier
application number: M008
unii: 62TEY51RR1
Walgreens Orange Antacid Soft ChewCALCIUM CARBONATEWalgreens5b01be31-5871-d4f5-e063-6294a90a671a2026-09-08WarningsExact identifier
unii: H0G9379FGK
Regular Strength Tropical FruitCALCIUM CARBONATERARITAN PHARMACEUTICALS INC38c6cece-71a0-40d8-bfc8-2f6467f9239b2026-09-05WarningsExact identifier
unii: H0G9379FGK
Extra Strength Antacid Assorted BerriesCALCIUM CARBONATERARITAN PHARMACEUTICALS INC07a50168-6b05-4c99-9969-7d7f0aa54f302026-09-05WarningsExact identifier
unii: H0G9379FGK
DRx CHOICE Antacid Calcium Regular StrengthCALCIUM CARBONATE 500MGRaritan Pharmaceuticals Inc0c579405-9397-4bf2-8441-e89011b19ec42026-09-05WarningsExact identifier
unii: H0G9379FGK
Tums Chewy Bites Wintermint and Vanilla CreamCALCIUM CARBONATEHaleon US Holdings LLC4f094feb-8de1-4ccb-e063-6294a90acec22026-09-04WarningsExact identifier
unii: H0G9379FGK
Psoriasis ControlCENTELLA ASIATICA, SODIUM CHLORIDE, AND SILICON DIOXIDEForces of Nature2db33771-0bb9-49f8-84fa-dddc28e4ba262026-09-04WarningsExact identifier
unii: ETJ7Z6XBU4
DG health Ultra Strength Assorted Fruit AntacidCALCIUM CARBONATEDOLGENCORP, LLC98a0503c-add5-4453-9d9d-6f813866f4b32026-09-03WarningsExact identifier
unii: H0G9379FGK
DG health Ultra Strength Assorted Berry AntacidCALCIUM CARBONATEDOLGENCORP, LLC99c7ab95-df12-4041-ae1a-398cc6f0085d2026-09-03WarningsExact identifier
unii: H0G9379FGK
DG HEALTH Ultra StrengthANTACID TABLETS (CALCIUM CARBONATE)DOLGENCORP, LLCe7be2ad1-c85c-4ac7-b6e7-641f979d0d6b2026-09-03WarningsExact identifier
unii: H0G9379FGK

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.