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 4 of 9 · 168 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Rena-ChordHOMEOPATHIC LIQUIDEnergetix Corporation4071f90a-8a28-4338-810b-c9b18cf32f872025-07-15WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEMajor Pharmaceuticals7688cce8-797d-454c-95fb-52689741582e2025-07-15Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDERising Pharma Holdings, Inc.ab431781-3183-4638-b656-f40a61f079402025-05-19Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
ApnetemPHOSPHORICUM ACIDUM, ALUMEN, PHOSPHORUS, SENEGA OFFICINALIS, ADENOSINUM CYCLOPHOSPHORICUM, ANTIMONIUM TARTARICUM, GRINDELIA, SABADILLA, ALUMINA, CUPRUM METALLICUM, SANGUINARINUM NITRICUM, SILICEA, LACHESIS MUTUS, RHEUM (PALMATUM), ZINCUM METALLICUM, LYCOPODIUM CLAVATUM, MANGANUM PHOSPHORICUM, ANTIPYRINUM, COENZYME ANucleic Products, LLCec5bc7e7-4be6-45a6-8cd9-62fdfa7fb4692025-05-14WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEAvKARE3418ca19-feb0-9821-e063-6394a90ae8192025-05-01Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin Chloride Extended ReleaseOXYBUTYNIN CHLORIDEAvPAK242b4766-bc2b-0073-d72d-1bf879bbee242025-04-17Warnings, Adverse reactionsExact identifier
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.9c8ced4b-94de-4df8-bea3-b42b8846b7692025-03-12Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.0c021aad-97a3-4404-a11e-cdd2ec731c6b2025-03-07Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Bestmade Natural Products AluminaALUMINABestmade Natural Products2f824dae-5cd2-5ac7-e063-6394a90aa9852025-03-04WarningsExact identifier
unii: LMI26O6933
YVTYVT MICRODERMABRASION FACIAL SCRUBYVTYVT MICRODERMABRASION FACIAL SCRUBBeijing JUNGE Technology Co., Ltd.2f30fc45-42e2-c766-e063-6394a90a8d682025-02-28WarningsExact identifier
unii: OP1R32D61U
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDEPD-Rx Pharmaceuticals, Inc.3a319017-4e25-402e-8ba0-63b9f1eb707e2025-02-27Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEChartwell RX, LLCd02e411b-2f34-4d08-a92a-9762cab472692025-02-26Adverse reactionsExact identifier
unii: L9F3D9RENQ
Ear Wax Build-UpELAPS CORALLINUS, ALUMINA, CARBO VEG., CAUSTICUM, CONIUM, GRAPHITES, KALI BIC.,KALI MUR., LACHESIS, LYCOPODIUM, PETROLEUM, PULSATILLA, SABADILLA, SEPIA, SILICEA, SPONGIA, VERBASCUM, VIOLA ODORATANewton Laboratories, Inc.9302b838-6003-ba6a-e053-2995a90aedd32025-02-06WarningsExact identifier
unii: LMI26O6933
Oxybutynin ChlorideOXYBUTYNIN CHLORIDEBryant Ranch Prepackf92cf6d0-5f49-40e2-a4f4-8ff377cacbfb2025-01-30Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d63b107-cd47-d9a5-e053-2a95a90a44932025-01-28WarningsExact identifier
unii: LMI26O6933
ConstipationECHINACEA, IRIS VERSICOLOR, PHYTOLACCA DECANDRA, TARAXACUM OFFICINALE, ABIES NIGRA, AESCULUS HIPPOCASTANUM, ALOE, ALUMINA, BRYONIA, CARBO VEGETABILIS, CHELIDONIUM MAJUS, COLLINSONIA CANADENSIS, GRAPHITE, HYDRASTIS CANADENSIS 15X, KALI CARBONICUM 15X, LYCOPODIUM CLAVATUM 15X, MAGNESIA MURIATICA 15X, MEZEREUM, NUX VOMICA, PODOPHYLLUM PELTATUM, RHAMNUS PURSHIANA, SANICULA, SELENIUM METALLICUM, SEPIA, SILICEA, TABACUM, VERATRUM ALBUM, ZINCUM METALLICUMNewton Laboratories, Inc.9d626292-7abb-1afb-e053-2995a90a28182025-01-24WarningsExact identifier
unii: LMI26O6933
Bestmade Natural Products BM40ALUMINAD7, CAUSTICUMD8, GELSEMIUMD3, MOSCHUSD14, PLUMBUMD9, SECALE CORND4, ZINCUM ACETD9Bestmade Natural Productsef43f183-1be9-4c7e-e053-2a95a90a4b062025-01-23WarningsExact identifier
unii: LMI26O6933
OXYBUTYNIN CHLORIDEOXYBUTYNIN CHLORIDERedpharm Drugfc4cfbe6-a940-41c0-e053-6294a90adb142025-01-23Warnings, Adverse reactionsExact identifier
rxcui: 863664
unii: L9F3D9RENQ
Bestmade Natural Products BM6AGRIMONIAD6, ALUMINAD12, HYDRASTISD4, KALI BICHD6, PULSATILLAD5, SEPIAD4Bestmade Natural Productsec034f53-5577-5985-e053-2995a90a67292025-01-22WarningsExact identifier
unii: LMI26O6933
Bestmade Natural Products BM21ALUMINAD5, BRYONIAD5, COLOCYNTHISD6, GRAPHITED10, HYDRASTISD3, LYCOPODIUMD4, MAG MURD12, NUX VOMICAD5,OPIUMD30, PLUMBUMD7Bestmade Natural Productsedc29044-5fae-7916-e053-2995a90a59882025-01-22WarningsExact identifier
unii: LMI26O6933

Reported adverse events (FAERS/openFDA)#

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