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 2 of 12 · 225 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEREMEDYREPACK INC.c1c89510-6381-466f-be1a-6b104a335b562026-06-09Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
unii: 059QF0KO0R
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATEBryant Ranch Prepack3749da41-19f3-46b2-887d-7f8ae22687002026-06-08Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Bacteriostatic WaterBACTERIOSTATIC WATERHospira, Inc.87d6e9dc-fe3b-4593-ac9a-d7493d1959c72026-05-22Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
WHITENING SUNSCREENANTI WRINKLEWHITENING SUNSCREENANTI WRINKLEShantou Oushiya Biotechnology Co.,Ltd524384e9-b3f8-4c13-e063-6394a90a89732026-05-20WarningsExact identifier
unii: 059QF0KO0R
PhenohytroPHENOBARBITAL, HYOSCYAMINE SULFATE, ATROPINE SULFATE, AND SCOPOLAMINE HYDROBROMIDEATLANTIC BIOLOGICALS CORP.a5aaf1db-1938-4073-9da4-c47f959d013e2026-05-19Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
DigenyxHYOSCYAMINE SULFATE 0.125 MGPureTek Corporation512f3202-4ecf-1218-e063-6294a90a05442026-05-12Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEPD-Rx Pharmaceuticals, Inc.51a07955-485f-1357-e063-6394a90ad3f82026-05-11Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Multi FlowerAESCULUS CARNEA, FLOS, AESCULUS HIPPOCASTANUM, FLOS, AGRIMONIA EUPATORIA, FLOS, BROMUS RAMOSUS, FLOS, CALLUNA VULGARIS, FLOS, CARPINUS BETULUS , FLOS, CASTANEA SATIVA, FLOS, CENTAURIUM UMBELLATUM, FLOS, CERATOSTIGMA WILLMOTTIANUM, FLOS, CICHORIUM INTYBUS, FLOS, CLEMATIS VITALBA, FLOS, CLEMATIS VITALBA, FLOS, FAGUS SYLVATICA, FLOS, GENTIANELLA AMARELLA, FLOS, HELIANTHEMUM NUMMULARIUM, FLOS, ILEX AQUIFOLIUM, FLOS, IMPATIENS GLANDULIFERA, FLOS, LARIX DECIDUA, FLOS, LONICERA CAPRIFOLIUM, FLOSEnergique, Inc.09c059e7-f748-402c-8447-af5b61169c582026-05-06WarningsExact identifier
unii: 059QF0KO0R
Hyoscyamine SulfateHYOSCYAMINE SULFATEGranulation Technology, Inc.4f863ae9-d010-b2f5-e063-6394a90a1a952026-04-15Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEGranulation Technology, Inc.d81bf93e-e73f-4b12-980b-33a5bf4531422026-04-10Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
KIDS TOOTHPASTE, FOR CAVITY PROTECTIONKIDS TOOTHPASTE FOR CAVITY PROTECTIONShulisa (Foshan) Daily ChemicalIndustry Co., Ltd4e8fab9e-f05c-5e2f-e063-6294a90aecf92026-04-03WarningsExact identifier
unii: 059QF0KO0R
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
TINTED SUNSCREEN FOUNDATIONTINTED SUNSCREEN FOUNDATIONGuanghzou AiXin Biotech Co Ltd396393c4-b50c-3877-e063-6294a90a0e9b2026-03-17WarningsExact identifier
unii: 059QF0KO0R
Hyoscyamine Sulfate SublingualHYOSCYAMINE SULFATE SUBLINGUALDirect_Rx4cc2a7a4-b549-b92a-e063-6294a90a51e32026-03-11Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
unii: 059QF0KO0R
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.f650dd78-615c-42d3-9b2d-3a989039d80c2026-03-05Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsExact identifier
unii: 059QF0KO0R
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
unii: 059QF0KO0R

Reported adverse events (FAERS/openFDA)#

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