FDA.reportPublic FDA data

NDC 54868-2157-4 - Oxybutynin Chloride

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
54868-2157
Requested NDC
54868-2157-4
Package NDCs from labels
54868-2157-1, 54868-2157-2, 54868-2157-3, 54868-2157-5, 54868-2157-4
Manufacturer
Physicians Total Care, Inc.
Effective date
2013-03-18
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
OXYBUTYNIN CHLORIDE Tablets USPPhysicians Total Care, Inc.2013-03-18HUMAN PRESCRIPTION DRUG LABEL
National Council for Prescription Drug Programs indexing - billing unitNational Council for Prescription Drug Programs2012-07-24Indexing - Billing Unit

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDCRelated label
54868-2157-1OXYBUTYNIN CHLORIDE Tablets USP
54868-2157-2OXYBUTYNIN CHLORIDE Tablets USP
54868-2157-3OXYBUTYNIN CHLORIDE Tablets USP
54868-2157-5OXYBUTYNIN CHLORIDE Tablets USP

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54868-2157-1Oxybutynin Chloride30 in 1 BOTTLETABLET304
54868-2157-2Oxybutynin Chloride100 in 1 BOTTLETABLET1004
54868-2157-3Oxybutynin Chloride60 in 1 BOTTLETABLET604
54868-2157-5Oxybutynin Chloride90 in 1 BOTTLE, PLASTICTABLET904

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54868-2157OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]44 package rows20130319_19fba9db-69ff-4136-ad6b-04a33b6b6789.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
54868-2157-1EA - Each54868-215702e0df2a-0dfd-439c-8c2b-61e8905739dc12012-07-24
54868-2157-2EA - Each54868-21570cab6182-6d98-4bb1-bbeb-384c0c0f42fa12012-07-24
54868-2157-3EA - Each54868-2157d5c96fe3-d79c-4f47-ab7b-ffe7bca50b5412012-07-24
54868-2157-4EA - Each54868-21577b0498cd-33dd-4e1e-a7fe-0182b79207c412012-07-24
54868-2157-5EA - Each54868-2157f88749e7-738e-4474-9bd8-58edb87ae4d912015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
OXYBUTYNIN CHLORIDEACTIVE INGREDIENTL9F3D9RENQOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
OXYBUTYNINACTIVE MOIETYK9P6MC7092OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ALUMINUM OXIDEINACTIVE INGREDIENTLMI26O6933OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
ANHYDROUS LACTOSEINACTIVE INGREDIENT3SY5LH9PMKOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CALCIUM STEARATEINACTIVE INGREDIENT776XM7047LOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61UOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBDOXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4
SODIUM STARCH GLYCOLATE TYPE A POTATOINACTIVE INGREDIENT5856J3G2A2OXYBUTYNIN CHLORIDE TABLET [PHYSICIANS TOTAL CARE, INC.]4

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 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dynamic BrainARGENTUM NITRICUM, CUPRUM ACETICUM, GINKGO BILOBA, KALI PHOSPHORICUM, LYCOPODIUM CLAVATUM, PHOSPHORICUM ACIDUM, THIAMINUM HYDROCHLORICUM, CEREBRUM SUIS, AMBRA GRISEA, PICRICUM ACIDUM, AGNUS CASTUS, ALUMINA, ANACARDIUM ORIENTALE, BARYTA CARBONICA, CICUTA VIROSA, CONIUM MACULATUM, HELLEBORUS NIGER, PLUMBUM METALLICUM, SELENIUM METALLICUM, ZINCUM METALLICUMDeseret Biologicals, Inc.60a1e44b-3f91-41de-82c2-4648fb800dcd2026-03-19WarningsExact identifier
unii: LMI26O6933
Skin Irritations and Itch ReliefAGARICUS MUSCARIUS, ALUMINA, ANAGALLIS ARVENSIS, ANTIMONIUM TARTARICUM, APIS MELLIFICA, ARSENICUM ALBUM, ARSENICUM IODATUM, BOVISTA, CAUSTICUM, DOLICHOS PRURIENS, FAGOPYRUM ESCULENTUM, GRAPHITES, KALI MURIATICUM, MURIATICUM ACIDUM, OLEANDER, PETROLEUM, PIX LIQUIDA, RADIUM BROMATUM (12X, 30X, 1LM), RHUS TOX, SELENIUM METALLICUM, SULPHUR AND URTICA URENS.King Bio Inc.d139d2f1-0369-4963-9f3d-c4cc0f1ea2dd2026-03-10WarningsExact identifier
unii: LMI26O6933
Total Body DetoxALUMINA, BRYONIA, CALCAREA IODATA, CANTHARIS, CARDUUS BENEDICTUS, CARDUUS MAR, CHELIDONIUM MAJ, CINCHONA OFFICINALIS, CYNARA SCOLYMUS, DIOSCOREA VILLOSA, HEPAR SULPHURIS CALCAREUM, IRIS VERSICOLOR, JUNIPERUS COMMUNIS, KALI IODATUM, MERCURIUS CORROSIVUS, MERCURIUS VIVUS, NATRUM CARBONICUM, NUX VOMICA, PLUMBUM METALLICUM, PTELEA TRIFOLIATA, RICINUS COMMUNIS, ROBINIA PSEUDOACACIA, SERUM ANGUILLAE, SOLIDAGO VIRGAUREA, SULPHUR, SULPHURICUM ACIDUM AND TARAXACUM OFFICINALE.King Bio Inc.c803733e-b5e2-46f2-bdfe-b239f38d93122026-03-04WarningsExact identifier
unii: LMI26O6933
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutionsb9d0e5c8-3a71-40a0-a7d3-44bc043392fa2026-02-17Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
oxybutynin chlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.a1f8be75-2eb9-4eef-8fb4-144ef2bf7ae12026-02-16Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEHeritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.9a551ec5-7e80-47c9-a7b9-f458c14781742026-02-16Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
MERC CORRALUMINA, BRYONIA, COLOCYNTHIS, CHINA OFF, LYCOPODIUM, THUJA OCC, NUX VOMBM Private Limited3b29d70d-f291-dad2-e063-6294a90a07f52026-02-12WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEChartwell Governmental & Specialty RX, LLC.46e78c72-a5a3-472f-9125-b120fa4eee312026-01-30Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAdvagen Pharma Limited7bd31561-4c76-4c6b-819b-4925498866732026-01-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEA-S Medication Solutions3688227b-7655-40ca-b34b-073a39fd60f42026-01-14Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Constipation ReliefALUMINUM OXIDE, BRYONIA ALBA ROOT, SODIUM CHLORIDE, GRAPHITE, SILICON DIOXIDEHomeocare Laboratories62374240-cd14-44e2-9405-5f8996faf0472026-01-12WarningsExact identifier
unii: LMI26O6933
Metex 6013METEXProfessional Complementary Health Formulas78371ca3-50a6-46f0-8ea6-7de57c5163752026-01-08WarningsExact identifier
unii: LMI26O6933
H-Clenz Drops 2026H-CLENZ DROPSProfessional Complementary Health Formulas5dd76d36-e3db-472a-82f8-30643e49eaf72026-01-08WarningsExact identifier
unii: LMI26O6933
Alumina Combination 9204ALUMINA COMBINATIONProfessional Complementary Health Formulas312cac13-2009-4b8f-a09b-9be2d2801df52026-01-08WarningsExact identifier
unii: LMI26O6933
Alopecia Formula 2139ALOPECIA FORMULAProfessional Complementary Health Formulasce0eaf67-a435-4167-b9ce-c0ff1f8a9dc22026-01-08WarningsExact identifier
unii: LMI26O6933
Colic Drops 2155COLIC DROPSProfessional Complementary Health Formulas17b9e92f-f4ed-48b4-ab02-8b7cba0a20272026-01-08WarningsExact identifier
unii: LMI26O6933
ColostatRHAMNUS PURSHIANA, SPIGELIA ANTHELMIA, TARAXACUM OFFICINALE, CAJUPUTUM, HYDRASTIS CANADENSIS, ALOE, ALUMINA, CINA, CINCHONA OFFICINALIS, LYCOPODIUM CLAVATUM, MAGNESIA PHOSPHORICA, NUX VOMICA, PODOPHYLLUM PELTATUMEnergique, Inc.3ddbed50-7ca9-493c-ba94-321c2afef60e2026-01-06WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLCf330b7a0-bbe0-0f00-e053-2a95a90a37b82026-01-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDENorthwind Health Company, LLC13a79659-a181-6a61-e063-6294a90ae0342025-12-26Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDECoupler LLC3f7dc283-b168-8251-e063-6294a90a45a22025-12-24Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ

Reported adverse events (FAERS/openFDA)#

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