FDA.reportPublic FDA data

NDC 71335-1159-03 - Hyoscyamine Sulfate SL

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
71335-1159
Requested NDC
71335-1159-03
Package NDCs from labels
71335-1159-0, 71335-1159-1, 71335-1159-2, 71335-1159-3, 71335-1159-4, 71335-1159-5, 71335-1159-6, 71335-1159-7, 71335-1159-8, 71335-1159-9, 71335-1159-03
Manufacturer
Bryant Ranch Prepack
Effective date
2026-06-08
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Hyoscyamine Sulfate SL - Bryant Ranch PrepackBryant Ranch Prepack2026-06-08HUMAN PRESCRIPTION DRUG LABEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71335-1159-0Hyoscyamine Sulfate SL10 in 1 BOTTLETABLET105
71335-1159-1Hyoscyamine Sulfate SL20 in 1 BOTTLETABLET205
71335-1159-2Hyoscyamine Sulfate SL30 in 1 BOTTLETABLET305
71335-1159-3Hyoscyamine Sulfate SL15 in 1 BOTTLETABLET155
71335-1159-4Hyoscyamine Sulfate SL21 in 1 BOTTLETABLET215
71335-1159-5Hyoscyamine Sulfate SL60 in 1 BOTTLETABLET605
71335-1159-6Hyoscyamine Sulfate SL12 in 1 BOTTLETABLET125
71335-1159-7Hyoscyamine Sulfate SL90 in 1 BOTTLETABLET905
71335-1159-8Hyoscyamine Sulfate SL100 in 1 BOTTLETABLET1005
71335-1159-9Hyoscyamine Sulfate SL45 in 1 BOTTLETABLET455

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1159HYOSCYAMINE SULFATE SL (HYOSCYAMINE SULFATE) TABLET [BRYANT RANCH PREPACK]5Current NDC, Legacy NDC, 10 package rows20241116_3749da41-19f3-46b2-887d-7f8ae2268700.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 5 · 85 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATERedpharm Drug584755e4-fea9-4827-e063-6394a90a4a0a2026-08-05Warnings, Adverse reactionsExact identifier
rxcui: 1046982
unii: F2R8V82B84
Hyoscyamine SulfateHYOSCYAMINE SULFATEGranulation Technology, Inc.57b12b25-adea-c9bc-e063-6394a90aa9252026-07-29Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate TABHYOSCYAMINE SULFATEREMEDYREPACK INC.c1c89510-6381-466f-be1a-6b104a335b562026-06-09Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Hyoscyamine Sulfate SLHYOSCYAMINE SULFATEBryant Ranch Prepack3749da41-19f3-46b2-887d-7f8ae22687002026-06-08Warnings, Adverse reactionsExact identifier
ndc (package): 71335-1159-2
ndc (package): 71335-1159-6
ndc (package): 71335-1159-7
ndc (package): 71335-1159-0
ndc (package): 71335-1159-3
ndc (package): 71335-1159-4
ndc (package): 71335-1159-8
ndc (package): 71335-1159-5
ndc (package): 71335-1159-1
ndc (package): 71335-1159-9
ndc (product): 71335-1159
ndc11 (package): 71335115903
rxcui: 1046982
spl id: b47f4839-f717-4afa-be2c-f33f6b5c71a3
spl set id: 3749da41-19f3-46b2-887d-7f8ae2268700
unii: F2R8V82B84
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
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
unii: O8232NY3SJ
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
unii: O8232NY3SJ
MannitolMANNITOLHospira, Inc.8ad3145e-00e7-4412-b9a5-06f00f264f302026-04-21Warnings, Adverse reactionsExact identifier
unii: 3OWL53L36A
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
rxcui: 1046982
unii: F2R8V82B84
Hyoscyamine Sulfate SublingualHYOSCYAMINE SULFATE SUBLINGUALDirect_Rx4cc2a7a4-b549-b92a-e063-6294a90a51e32026-03-11Warnings, Adverse reactionsExact identifier
rxcui: 1046982
unii: F2R8V82B84
UROGESIC BLUEMETHENAMINE, SODIUM PHOSPHATE, MONOBASIC, METHYLENE BLUE, AND HYOSCYAMINE SULFATEEDWARDS PHARMACEUTICALS, INC.f650dd78-615c-42d3-9b2d-3a989039d80c2026-03-05Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84
Lotrimin Daily Sweat and Odor ControlTOPICAL STARCHBayer HealthCare LLC.9ec5c80d-b550-496f-e053-2a95a90a54892026-01-16WarningsExact identifier
unii: O8232NY3SJ
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
Medicated Cornstarch Baby PowderACTIVE CORN STARCHDavion, Inc.e39032d1-c8cd-4a41-af10-126970b8ad382025-12-29WarningsExact identifier
unii: O8232NY3SJ
HYOSCYAMINE SULFATEHYOSCYAMINE SULFATEBPI Labs LLC6c0a1fef-c634-4ecf-9850-d188e6496b902025-12-26Warnings, Adverse reactionsExact identifier
unii: F2R8V82B84

Reported adverse events (FAERS/openFDA)#

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