FDA.reportPublic FDA data

lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]

RxCUI
1011703
RxNorm name
lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]
Display name
AKTEN (Ophthalmic)
Full name
lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]
Term type
SBD
Status
Active
Strength
3.5%
Dose form
Gel
Route
Ophthalmic
Updated
2026-08-01 06:51:15

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
102010
Active start
102010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
lidocaine hydrochloride0.035 MG / 1 MGlidocainelidocaine hydrochloride

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Ophthalmic Gel316963

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
lidocaine6387

Source Vocabulary Codes#

Code type, Value, Category table
Code typeValueCategory
PRESCRIBABLEYATTRIBUTES
RXNAV_STRAkten 3.5 % Ophthalmic GelNAMES
RxNorm Namelidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]NAMES
RxNorm SynonymAkten 0.035 MG/MG Ophthalmic GelNAMES
RxNorm SynonymAkten 3.5 % Ophthalmic GelNAMES
TTYSBDATTRIBUTES
SPL_SET_ID70ff9fb7-d323-4fe6-b1b1-6033e05f0749CODES
RxCUI1011703CODES
MMSL_CODEBD24630CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
82584-792-0182584-792AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUSThea Pharma Inc.NDA022221
82584-792-2582584-792AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUSThea Pharma Inc.NDA022221

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA02222182584-792AKTEN LIDOCAINE HYDROCHLORIDE ANHYDROUSNDAThea Pharma Inc.

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 5 matching rows.

NDC11, Source, Active table
NDC11SourceActive
17478079201rxnav_ndcsyes
17478079225rxnav_ndcsyes
82584079201rxnav_ndcsyes
82584079225rxnav_ndcsyes
17478079210rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AKTENLIDOCAINE HYDROCHLORIDE ANHYDROUSThea Pharma Inc.70ff9fb7-d323-4fe6-b1b1-6033e05f07492026-04-23Warnings, Adverse reactionsExact identifier
ndc (package): 82584-792-01
ndc (package): 82584-792-25
ndc (product): 82584-792
ndc11 (package): 82584079201
ndc11 (package): 82584079225
rxcui: 1011703

DailyMed RxNorm Mappings#

Set ID, RxNorm string, TTY table
Set IDRxNorm stringTTYSPL versionLabelEffective
c1f638dc-c386-45e8-9adc-d0f295794679Akten 3.5 % Ophthalmic GelSY15These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 197220211115
c1f638dc-c386-45e8-9adc-d0f295794679Akten 0.035 MG/MG Ophthalmic GelSY15These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 197220211115
c1f638dc-c386-45e8-9adc-d0f295794679Akten 3.5 % Ophthalmic GelPSN15These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 197220211115
c1f638dc-c386-45e8-9adc-d0f295794679lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]SBD15These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 197220211115
70ff9fb7-d323-4fe6-b1b1-6033e05f0749Akten 3.5 % Ophthalmic GelSY9These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for Akten ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 197220260423
70ff9fb7-d323-4fe6-b1b1-6033e05f0749lidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]SBD9These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for Akten ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 197220260423
70ff9fb7-d323-4fe6-b1b1-6033e05f0749Akten 3.5 % Ophthalmic GelPSN9These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for Akten ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 197220260423
70ff9fb7-d323-4fe6-b1b1-6033e05f0749Akten 0.035 MG/MG Ophthalmic GelSY9These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for Akten ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 197220260423

DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
70ff9fb7-d323-4fe6-b1b1-6033e05f0749These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for Akten ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 1972Thea Pharma Inc.20260423
70ff9fb7-d323-4fe6-b1b1-6033e05f0749These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for Akten ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use. Initial U.S. Approval: 1972Thea Pharma Inc.20251208
c1f638dc-c386-45e8-9adc-d0f295794679These highlights do not include all the information needed to use AKTEN ® safely and effectively. See full prescribing information for AKTEN ® . AKTEN ® (lidocaine hydrochloride ophthalmic gel), for topical ophthalmic use Initial U.S. Approval: 1972Akorn | Akorn Operating Company LLC | Akorn AG20211115
2a5522b2-f2ed-476a-b8a3-73f9a18992cfNational Council for Prescription Drug Programs20130213
ec647c78-2e35-4247-aa1c-72c9faba3be4National Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCN01BBAmidesATC1-4lidocaine
ATCS02DAAnalgesics and anestheticsATC1-4lidocaine
ATCD04ABAnesthetics for topical useATC1-4lidocaine
ATCR02ADAnesthetics, localATC1-4lidocaine
ATCC01BBAntiarrhythmics, class IbATC1-4lidocaine
ATCS01HALocal anestheticsATC1-4lidocaine
ATCC05ADLocal anestheticsATC1-4lidocaine
FDASPLN0000175682Amide Local AnestheticEPChas_epclidocaine
FDASPLN0000175426AntiarrhythmicEPChas_epclidocaine
FDASPLN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine hydrochloride
MEDRTD008012LidocaineCHEMhas_ingredientlidocaine
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine hydrochloride
MEDRTD000219Adams-Stokes SyndromeDISEASEci_withlidocaine
MEDRTD002056BurnsDISEASEmay_treatlidocaine hydrochloride
MEDRTD002056BurnsDISEASEmay_treatlidocaine
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD004342Drug HypersensitivityDISEASEci_withlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine
MEDRTD064420Drug-Related Side Effects and Adverse ReactionsDISEASEmay_treatlidocaine hydrochloride
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine
MEDRTD004935Esophageal DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine hydrochloride
MEDRTD006967HypersensitivityDISEASEci_withlidocaine
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine hydrochloride
MEDRTD009059Mouth DiseasesDISEASEmay_treatlidocaine
MEDRTD009203Myocardial InfarctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine hydrochloride
MEDRTD010146PainDISEASEmay_preventlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine
MEDRTD010146PainDISEASEmay_treatlidocaine hydrochloride
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine
MEDRTD013614Tachycardia, ParoxysmalDISEASEmay_treatlidocaine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine hydrochloride
MEDRTD017180Tachycardia, VentricularDISEASEmay_treatlidocaine
MEDRTD018754Ventricular DysfunctionDISEASEmay_treatlidocaine hydrochloride
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine
MEDRTD014693Ventricular FibrillationDISEASEmay_treatlidocaine hydrochloride
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine
MEDRTD018879Ventricular Premature ComplexesDISEASEmay_treatlidocaine hydrochloride
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine
MEDRTN0000000180Sodium Channel InteractionsMOAhas_moalidocaine hydrochloride
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine
MEDRTN0000008330Cardiac Rhythm AlterationPEhas_pelidocaine hydrochloride
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008472Decreased Cardiac Muscle Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine
MEDRTN0000008889Decreased Sensory-Somatic Nervous System Organized Electrical ActivityPEhas_pelidocaine hydrochloride
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine
MEDRTN0000175976Local AnesthesiaPEhas_pelidocaine hydrochloride

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.035 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESPRESCRIBABLEY
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
ATTRIBUTESTTYSBD
CODESMMSL_CODEBD24630
CODESNDANDA022221
CODESRxCUI1011703
CODESSPL_SET_ID70ff9fb7-d323-4fe6-b1b1-6033e05f0749
NAMESPrescribable SynonymAkten 3.5 % Ophthalmic Gel
NAMESRXNAV_STRAkten 3.5 % Ophthalmic Gel
NAMESRxNorm Namelidocaine hydrochloride 0.035 MG/MG Ophthalmic Gel [Akten]
NAMESRxNorm SynonymAkten 0.035 MG/MG Ophthalmic Gel
NAMESRxNorm SynonymAkten 3.5 % Ophthalmic Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon