FDA.reportPublic FDA data

NDC 81033-020-01 - Mupirocin

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
81033-020
Requested NDC
81033-020-01
Package NDCs from labels
81033-020-01, 81033-020-50, 81033-020-99
Manufacturer
Kesin Pharma Corporation
Effective date
2025-05-28
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Mupirocin Ointment - Kesin Pharma CorporationKesin Pharma Corporation2025-05-28HUMAN PRESCRIPTION DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
81033-020-502024-03-20These highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
81033-020-992024-03-20These highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
81033-020-502023-07-28These highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987
81033-020-992023-07-28These highlights do not include all the information needed to use MUPIROCIN OINTMENT safely and effectively. See full prescribing information for MUPIROCIN OINTMENT. MUPIROCIN ointment, for topical use Initial U.S. Approval: 1987

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81033-020-01Mupirocin1 g in 1 TUBEOINTMENT17
81033-020-50Mupirocin50 in 1 PACKAGEOINTMENT507
81033-020-99Mupirocin100 in 1 PACKAGEOINTMENT1007

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81033-020MUPIROCIN OINTMENT [KESIN PHARMA CORPORATION]5Legacy NDC, 3 package rows20241027_b8e115ce-c8ff-4d08-b865-71dc4d0e51a1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81033-020-01GM - Gram81033-02061dd1f57-348f-4d00-8a69-157d0da92fc112024-04-05
81033-020-50GM - Gram81033-02029b83f55-39d8-4992-a617-0293247edb2c12022-12-07
81033-020-99GM - Gram81033-020e8db7979-0ddd-4980-b276-3a66b961ef8512022-12-07

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 8 of 13 · 259 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GAVILYTE-NPOLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATELupin Pharmaceuticals,Inc.27195187-75a3-431f-90d9-84da1b94e8492025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GaviLyte - C TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACKLupin Pharmaceuticals,Inc.a8b15625-ca7c-4d57-9f36-3ac2a6d136652025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GAVILYTE G TMPOLYETHYLENE GLYCOL-3350 AND ELECTROLYTESLupin Pharmaceuticals,Inc.3978822b-6473-4072-9f80-20ceb9bea3552025-09-10Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350 and electrolytes - UnflavoredPOLYETHYLENE GLYCOL 3350 AND ELECTROLYTES - UNFLAVOREDStrides Pharma Science Limited48c741a9-9039-4fdb-a875-86d4ea9682822025-09-05Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride - UnflavoredPOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE - UNFLAVOREDStrides Pharma Science Limited37c111ec-5b62-42b9-bbb2-3b0c530e34c92025-09-01Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
clearlaxPOLYETHYLENE GLYCOL 3350Meijer, Inc.8cca18a8-94f6-43f6-bdb7-2d44a6cdf1512025-08-08WarningsExact identifier
unii: G2M7P15E5P
Systane UltraPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.0537c23a-15f7-be64-1231-a6c93468e9a82025-07-30WarningsExact identifier
unii: B697894SGQ
SystanePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.1d679d0f-cec2-a644-79cd-079607254bb92025-07-30WarningsExact identifier
unii: B697894SGQ
Systane Ultra Preservative FreePOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAlcon Laboratories, Inc.751fb85f-6683-4b0a-a650-324d4a74c5de2025-07-30WarningsExact identifier
unii: B697894SGQ
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
unii: G2M7P15E5P
MupirocinMUPIROCINSun Pharmaceutical Industries, Inc.900bb675-2f03-47e3-854e-257ec48313322025-07-07Warnings, Adverse reactionsExact identifier
rxcui: 106346
unii: D0GX863OA5
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Morning Star OTCdcd4164c-aa1e-4f07-ab2c-b439275629db2025-06-16WarningsExact identifier
unii: B697894SGQ
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Kesin Pharma Corporation3729a1d2-4c98-dfdf-e063-6394a90a5a872025-06-12WarningsExact identifier
unii: G2M7P15E5P
CLEARLAXPOLYETHYLENE GLYCOL 3350STRATEGIC SOURCING SERVICES LLC041157b8-476c-e7d2-e063-6394a90ac3a02025-06-11WarningsExact identifier
unii: G2M7P15E5P
mupirocinMUPIROCINATLANTIC BIOLOGICALS CORP.da2f7d4e-82c6-4790-8eea-3a97e5b307342025-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA065123
rxcui: 106346
unii: D0GX863OA5
MupirocinMUPIROCIN OINTMENTKesin Pharma Corporationb8e115ce-c8ff-4d08-b865-71dc4d0e51a12025-05-28Warnings, Adverse reactionsExact identifier
application number: ANDA065123
ndc (package): 81033-032-50
ndc (package): 81033-020-01
ndc (package): 81033-020-50
ndc (package): 81033-020-99
ndc (package): 81033-032-01
ndc (package): 81033-032-99
ndc (product): 81033-020
ndc (product): 81033-032
ndc11 (package): 81033002001
rxcui: 106346
spl id: 36357344-6528-ef04-e063-6394a90a8fa9
spl set id: b8e115ce-c8ff-4d08-b865-71dc4d0e51a1
unii: D0GX863OA5
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Camber Consumer Care Incb321a7f5-f80b-4a51-9fd9-2c21fc1cae9b2025-04-23WarningsExact identifier
unii: G2M7P15E5P
good neighbor pharmacy clearlaxPOLYETHYLENE GLYCOL 3350Amerisource Bergene0b419b6-6ce0-4aaa-948f-dee5b2ec20822025-04-17WarningsExact identifier
unii: G2M7P15E5P
WincoPOLYETHYLENE GLYCOL 3350WINCO FOODSd649f758-a46f-4864-8718-878ee5a74bfc2025-04-10WarningsExact identifier
unii: G2M7P15E5P
MupirocinMUPIROCINLohxa6d59e35c-b262-7940-e053-2991aa0a89082025-03-25Warnings, Adverse reactionsExact identifier
rxcui: 106346
unii: D0GX863OA5

Reported adverse events (FAERS/openFDA)#

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