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 3 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
unii: 059QF0KO0R
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
unii: 059QF0KO0R
URIBEL TABSMETHENAMINE, BENZOIC ACID, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEMission Pharmacal Company09821e01-1135-e75c-e063-6294a90a34512026-01-08WarningsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATENorthwind Health Company, LLCda704abd-4e60-f32e-e053-2a95a90a28302026-01-01Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATENorthwind Health Company, LLCf75765ce-262c-e832-e053-6394a90a60662026-01-01Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Eye CleanEYE WASHHART Health41f53e2e-c2bc-4bf1-a541-3bcb2cf630022025-12-31WarningsExact identifier
unii: 059QF0KO0R
teeth and gumsCALC FLUORICA, CALC PHOS, FERRUM PHOS, KALI PHOS, MAG PHOS, MALUS PUMILA, FLOS, ROCK WATER, ULEX EUROPAEUS, FLOSSiddha Flower Essences LLC926c79d5-d270-4c0d-aca9-b58571c24f3a2025-12-31WarningsExact identifier
unii: 059QF0KO0R
lung and sinusCALC PHOS, FERRUM PHOS, GENTIANELLA AMARELLA, FLOS, KALI MUR, KALI PHOS, KALI SULPH, ROCK WATER, ROSE CANINA, FLOSSiddha Flower Essences LLC9f7c949f-21bc-473c-ab8d-24837893fccc2025-12-31WarningsExact identifier
unii: 059QF0KO0R
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsExact identifier
unii: 059QF0KO0R
Rite Aid Eye WashPURIFIED WATERRite Aid28a18e04-d735-a511-e063-6394a90af6bb2025-12-30WarningsExact identifier
unii: 059QF0KO0R
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsExact identifier
unii: 059QF0KO0R
Kollourion Eyesalve EyewashPURIFIED WATER 98.3%Miracle Eye Pharmaceuticalsb56d2ab9-169b-b490-e053-2a95a90a80b32025-12-28WarningsExact identifier
unii: 059QF0KO0R
HYOSCYAMINE SULFATEHYOSCYAMINE SULFATEBPI Labs LLC6c0a1fef-c634-4ecf-9850-d188e6496b902025-12-26Warnings, Adverse reactionsExact identifier
ndc (package): 54288-111-01
ndc (package): 54288-111-05
ndc (product): 54288-111
ndc11 (package): 54288011101
rxcui: 1047916
spl id: ba3bb8f4-5954-40a8-a072-2f75edb2c102
spl set id: 6c0a1fef-c634-4ecf-9850-d188e6496b90
unii: F2R8V82B84
Uretron D/SMETHENAMINE, SODIUM PHOSPHATE MONOBASIC, PHENYL SALICYLATE, METHYLENE BLUE, AND HYOSCYAMINE SULFATEDORAL PHARMAMEDICS INC dba A.G. Marin Pharmaceuticalsea74f1aa-2b4d-4ccf-e053-2995a90abab52025-12-18Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEQPharma, Inc.fc7566e6-c043-fcd4-e053-6294a90a77e52025-12-16Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Firstep FirstflushEYEWASHEncon Safety Products, Inc.a44beb26-79ae-98bd-e053-2995a90a9b742025-12-09WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsExact identifier
unii: 059QF0KO0R
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsExact identifier
unii: 059QF0KO0R
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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