FDA.reportPublic FDA data

gentamicin 1 MG/ML Topical Cream

RxCUI
197735
RxNorm name
gentamicin 1 MG/ML Topical Cream
Display name
Gentamicin (Topical)
Full name
gentamicin 1 MG/ML Topical Cream
Term type
SCD
Status
Active
Strength
0.1%
Dose form
Cream
Route
Topical
Updated
2026-11-02 18:18:12

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
042005
Active start
042005
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
gentamicin sulfate1 MG / 1 MLgentamicingentamicin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
gentamicin1596450

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRgentamicin 1 MG/ML Topical Cream1NAMES
RxNorm Namegentamicin 1 MG/ML Topical Cream1NAMES
RxNorm Synonymgentamicin (as gentamicin sulfate) 0.1 % Topical Cream1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
3 linked values
3CODES
RxCUI1977351CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0713-0683-150713-0683Gentamicin Sulfate Gentamicin SulfateCosette Pharmaceuticals, Inc.ANDA064056
0713-0683-310713-0683Gentamicin Sulfate Gentamicin SulfateCosette Pharmaceuticals, Inc.ANDA064056
45802-056-1145802-056Gentamicin Sulfate Gentamicin SulfatePadagis Israel Pharmaceuticals LtdANDA062307
45802-056-3545802-056Gentamicin Sulfate Gentamicin SulfatePadagis Israel Pharmaceuticals LtdANDA062307

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA0640560713-0683Gentamicin Sulfate Gentamicin SulfateANDACosette Pharmaceuticals, Inc.
ANDA06230745802-056Gentamicin Sulfate Gentamicin SulfateANDAPadagis Israel Pharmaceuticals Ltd

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 63 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00247074015rxnav_ndcsyes
00713068315rxnav_ndcsyes
00713068331rxnav_ndcsyes
45802005611rxnav_ndcsyes
45802005635rxnav_ndcsyes
52565008515rxnav_ndcsyes
52565008530rxnav_ndcsyes
63739005565rxnav_ndcsyes
63739005566rxnav_ndcsyes
70512003630rxnav_ndcsyes
00085000805rxnav_historical
00102323515rxnav_historical
00157029544rxnav_historical
00168007115rxnav_historical
00182140351rxnav_historical
00223430415rxnav_historical
00247185715rxnav_historical
00302313015rxnav_historical
00349823135rxnav_historical
00364730556rxnav_historical
00364730572rxnav_historical
00414005605rxnav_historical
00462007115rxnav_historical
00485006030rxnav_historical
00536447020rxnav_historical
00536447028rxnav_historical
00580087822rxnav_historical
00603776974rxnav_historical
00677070940rxnav_historical
00686005605rxnav_historical
00686005635rxnav_historical
00719518050rxnav_historical
00781731027rxnav_historical
00814344693rxnav_historical
00839649247rxnav_historical
00884368415rxnav_historical
00904266336rxnav_historical
12939041515rxnav_historical
13411047315rxnav_historical
16590010715rxnav_historical
23317018015rxnav_historical
24208047089rxnav_historical
45802005605rxnav_historical
49158016216rxnav_historical
49158016220rxnav_historical
49158016268rxnav_historical
51079015761rxnav_historical
51432091511rxnav_historical
51672301001rxnav_historical
51672301002rxnav_historical
51672301101rxnav_historical
51672301102rxnav_historical
52446091974rxnav_historical
52493033615rxnav_historical
54569111700rxnav_historical
54868352400rxnav_historical
54868352401rxnav_historical
55045114705rxnav_historical
55887087615rxnav_historical
58016302601rxnav_historical
58016469601rxnav_historical
63874013215rxnav_historical
63874013230rxnav_historical

UNII Substances#

UNII substance links page 1 of 1 · 0 matching rows.

No records found.

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 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gentamicin SulfateGENTAMICIN SULFATECosette Pharmaceuticals, Inc.9e550dc9-509e-da05-8a97-ecbd0f5dd6332023-11-22Adverse reactionsExact identifier
ndc (package): 0713-0683-15
ndc (package): 0713-0683-31
ndc (product): 0713-0683
ndc11 (package): 00713068331
ndc11 (package): 00713068315
rxcui: 197735
Gentamicin SulfateGENTAMICIN SULFATEPadagis Israel Pharmaceuticals Ltd4cfbe37e-11d6-46fc-b287-0561387b17b72023-01-31Adverse reactionsExact identifier
ndc (package): 45802-056-35
ndc (package): 45802-056-11
ndc (product): 45802-056
ndc11 (package): 45802005611
ndc11 (package): 45802005635
rxcui: 197735

Reported adverse events (FAERS/openFDA)#

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

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 7 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4cfbe37e-11d6-46fc-b287-0561387b17b7gentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]313Gentamicin Sulfate Cream USP, 0.1%20230131
9e550dc9-509e-da05-8a97-ecbd0f5dd633gentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]35GENTAMICIN SULFATE CREAM, USP 0.1% For Dermatologic Use Only Not For Ophthalmic Use Rx Only20231122
e673c84f-d3cc-4e61-bdc7-5679cde9f359gentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]33GENTAMICIN SULFATE CREAM USP, 0.1% - gentamicin sulfate cream20121002
c302559f-9e0e-4c55-857c-8fda546d61f0gentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]31Gentamicin Sulfate Cream USP, 0.1%20210525
c08321a0-4961-9d3b-8e17-728470f5d653gentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]31GENTAMICIN SULFATE CREAM USP, 0.1%20191018
e2eed774-9a41-4a03-b8c0-e785fabf3228gentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]3120110317
210dde2f-6ea0-4068-8f6c-b9d62c67d12agentamicin sulfate 0.1 % Topical Cream [PSN] · gentamicin 1 MG/ML Topical Cream [SCD] · gentamicin (as gentamicin sulfate) 0.1 % Topical Cream [SY]3120110309

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
9e550dc9-509e-da05-8a97-ecbd0f5dd633GENTAMICIN SULFATE CREAM, USP 0.1% For Dermatologic Use Only Not For Ophthalmic Use Rx OnlyCosette Pharmaceuticals, Inc. | Cosette Pharmaceuticals NC Laboratories, LLC20231122
4cfbe37e-11d6-46fc-b287-0561387b17b7Gentamicin Sulfate Cream USP, 0.1%Padagis Israel Pharmaceuticals Ltd20230131
c302559f-9e0e-4c55-857c-8fda546d61f0Gentamicin Sulfate Cream USP, 0.1%McKesson Corporation | Teligent, Inc.20210525
a2b5d3ff-920d-280a-e053-2995a90ac84fGENTAMICIN SULFATE CREAM USP, 0.1% For Dermatoligic Use Only Not for Opthalmic Use RX OnlySola Pharmaceuticals20200407
c08321a0-4961-9d3b-8e17-728470f5d653GENTAMICIN SULFATE CREAM USP, 0.1%Teligent Pharma, Inc.20191018
e673c84f-d3cc-4e61-bdc7-5679cde9f359GENTAMICIN SULFATE CREAM USP, 0.1% - gentamicin sulfate creamDispensing Solutions, Inc. | PSS World Medical, Inc.20121002
3171b3ad-bd90-4e73-a43b-0a5e01c6fb48National Council for Prescription Drug Programs20120724
3629159e-c462-454d-aa64-f1d2ea2fa3c3National Council for Prescription Drug Programs20120724
63bbae86-a2c8-4c87-97c8-4e095a9de492National Council for Prescription Drug Programs20120724
8688d6fc-43c6-47cd-9ffc-fc23fe4d5aceNational Council for Prescription Drug Programs20120724
e2eed774-9a41-4a03-b8c0-e785fabf3228STAT RX USA LLC20110317
210dde2f-6ea0-4068-8f6c-b9d62c67d12aPhysicians Total Care, Inc.20110309

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCS01AAAntibioticsATC1-4gentamicin
ATCS03AAAntiinfectivesATC1-4gentamicin
ATCS02AAAntiinfectivesATC1-4gentamicin
ATCJ01GBOther aminoglycosidesATC1-4gentamicin
ATCD06AXOther antibiotics for topical useATC1-4gentamicin
FDASPLD000617AminoglycosidesCHEMhas_chemical_structuregentamicin
FDASPLN0000175477Aminoglycoside AntibacterialEPChas_epcgentamicin
MEDRTD005839GentamicinsCHEMhas_ingredientgentamicin
MEDRTD001850Bone Diseases, InfectiousDISEASEmay_treatgentamicin
MEDRTD002494Central Nervous System InfectionsDISEASEmay_treatgentamicin
MEDRTD004696EndocarditisDISEASEmay_treatgentamicin
MEDRTD004697Endocarditis, BacterialDISEASEmay_preventgentamicin
MEDRTD004927Escherichia coli InfectionsDISEASEmay_treatgentamicin
MEDRTD015818Eye Infections, BacterialDISEASEmay_treatgentamicin
MEDRTD006967HypersensitivityDISEASEci_withgentamicin
MEDRTD007710Klebsiella InfectionsDISEASEmay_treatgentamicin
MEDRTD014395Peritonitis, TuberculousDISEASEmay_treatgentamicin
MEDRTD011512Proteus InfectionsDISEASEmay_treatgentamicin
MEDRTD011552Pseudomonas InfectionsDISEASEmay_treatgentamicin
MEDRTD012141Respiratory Tract InfectionsDISEASEmay_treatgentamicin
MEDRTD018805SepsisDISEASEmay_treatgentamicin
MEDRTD016868Serratia InfectionsDISEASEmay_treatgentamicin
MEDRTD017192Skin Diseases, BacterialDISEASEmay_treatgentamicin
MEDRTD018461Soft Tissue InfectionsDISEASEmay_treatgentamicin
MEDRTD013203Staphylococcal InfectionsDISEASEmay_treatgentamicin
MEDRTD014552Urinary Tract InfectionsDISEASEmay_treatgentamicin
MEDRTN0000000150Protein Synthesis InhibitorsMOAhas_moagentamicin
MEDRTN0000008476Decreased Cell Membrane IntegrityPEhas_pegentamicin
MEDRTN0000008841Decreased Protein SynthesisPEhas_pegentamicin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH1 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA062307
CODESANDAANDA064056
CODESANDAANDA209304
CODESSNOMEDCT784949006
CODESVUID4004128
NAMESPrescribable Synonymgentamicin sulfate 0.1 % Topical Cream
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceUS Edition of SNOMED_CT
SOURCESSourceVeterans Health Administration National Drug File