FDA.reportPublic FDA data

NDC 54288-111-01 - HYOSCYAMINE SULFATE

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
54288-111
Requested NDC
54288-111-01
Package NDCs from labels
54288-111-01, 54288-111-05
Manufacturer
BPI Labs LLC
Effective date
2025-12-26
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
HYOSCYAMINE SULFATE - BPI Labs LLCBPI Labs LLC2025-12-26HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54288-111-01HYOSCYAMINE SULFATE1 mL in 1 VIALINJECTION, SOLUTION110
54288-111-05HYOSCYAMINE SULFATE5 in 1 CARTONINJECTION, SOLUTION510

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54288-111HYOSCYAMINE SULFATE INJECTION, SOLUTION [BPI LABS LLC]9Current NDC, Legacy NDC, 2 package rows20250213_6c0a1fef-c634-4ecf-9850-d188e6496b90.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54288-111-01ML - Milliliter54288-1110017a589-20e0-4166-b053-9f0fd097047d12019-11-12
54288-111-05ML - Milliliter54288-1112073e957-68f3-4078-adc6-3256195cbe7812019-11-12

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 5 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATEAcella Pharmaceuticals, LLC8aab1dce-0699-4866-8707-33b4e2177bdd2025-10-02Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEAcella Pharmaceuticals, LLC49fe1783-ab0c-4adb-869b-384121cf7f052025-10-02Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Xpect EyewashEYEWASHCintas Corporation1d69365d-662b-4248-8fa9-1629451b549a2025-09-30WarningsExact identifier
unii: 059QF0KO0R
CheBoho TEA TREE ACNECHEBOHO TEA TREE ACNEOpalshi(Guangzhou)E-commerce Co. Ltd.3fc4cf84-b2da-c593-e063-6394a90abc5c2025-09-27WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERProPharma Distribution3f2ae880-852f-b45d-e063-6394a90aa1cc2025-09-19Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.3859133e-88bd-4dd5-90a0-82b64347f1db2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.48fa3d71-8c78-4f29-b1f0-ecac8c36473e2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.cdb8f10a-b426-448f-8991-7724ffa88cb52025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEANI Pharmaceuticals, Inc.66fdfc33-a7b9-465b-84f1-012cdf5517fd2025-09-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Medi-First First Aid Eye WashPURIFIED WATERUnifirst First Aid Corporationdcd7fe56-ff5c-4c8d-a415-6e363d7e53f42025-09-08WarningsExact identifier
unii: 059QF0KO0R
Green Guard First Aid Eye WashWATERUnifirst First Aid Corporationa4ba5526-b4e2-4bcc-9127-aa22ebf5017f2025-09-08WarningsExact identifier
unii: 059QF0KO0R
Medi-First Plus First Aid Eye WashWATERUnifirst First Aid Corporationd7ea80ca-b4a0-4476-8b50-b3425c6d456a2025-09-08WarningsExact identifier
unii: 059QF0KO0R
ECOLAB Eye WashPURIFIED WATERECOLAB Food Safety Specialties, Inc.4bcfa21a-791e-4d04-e054-00144ff88e882025-09-08WarningsExact identifier
unii: 059QF0KO0R
Physicians Care EyewashEYEWASHAcme United Corporation3e239b12-9a75-339d-e063-6294a90a72ae2025-09-06WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATER INJECTIONHenry Schein, Inc.3501952b-b556-4d5e-b81b-5c35ff87b4752025-08-28Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.d820e42d-ad2b-4e11-907b-a94d698ca2852025-08-13Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
LevsinHYOSCYAMINE SULFATEViatris Specialty LLC32388e18-08de-455c-aad4-9c2264435f0f2025-07-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
LevbidHYOSCYAMINE SULFATEViatris Specialty LLCeb13c96f-319a-46f4-9955-ef5fa0a5f1102025-07-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
NuLevHYOSCYAMINE SULFATEViatris Specialty LLCae2a78b2-b811-11e2-9e96-0800200c9a662025-07-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Sterile WaterSTERILE WATERNephron Pharmaceuticals Corporationbc04a883-babc-87a6-e053-2995a90a3dfd2025-07-11Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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