FDA.reportPublic FDA data

tretinoin 0.0008 MG/MG Topical Gel

RxCUI
1488045
RxNorm name
tretinoin 0.0008 MG/MG Topical Gel
Display name
Tretinoin (Topical)
Full name
tretinoin 0.0008 MG/MG Topical Gel
Term type
SCD
Status
Active
Strength
0.08%
Dose form
Gel
Route
Topical
Updated
2026-08-12 12:30:50

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
032014
Active start
032014
Multiple ingredient
NO
Branded
NO

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
tretinoin0.0008 MG / 1 MGtretinointretinoin

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
tretinoin10753

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRtretinoin 0.0008 MG/MG Topical Gel1NAMES
RxNorm Nametretinoin 0.0008 MG/MG Topical Gel1NAMES
RxNorm Synonymtretinoin 0.08 % Topical Gel1NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
5 linked values
5CODES
RxCUI14880451CODES
MMSL_CODE
2 linked values
2CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
21922-043-4021922-043TRETINOIN TretinoinEncube Ethicals, Inc.ANDA215609
68308-777-5068308-777Tretinoin (Microsphere) tretinoinMayne PharmaANDA215609
68682-515-9568682-515Tretinoin TretinoinOceanside PharmaceuticalsNDA020475
69238-2323-169238-2323Tretinoin TretinoinAmneal Pharmaceuticals NY LLCANDA217497
72162-2303-272162-2303Tretinoin TretinoinBryant Ranch PrepackANDA215609

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
ANDA21560921922-043TRETINOIN TretinoinANDAEncube Ethicals, Inc.
NDA02047568682-515Tretinoin TretinoinNDA AUTHORIZED GENERICOceanside Pharmaceuticals
ANDA21749769238-2323Tretinoin TretinoinANDAAmneal Pharmaceuticals NY LLC

RxNav Current And Historical NDCs#

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

NDC11, Source, Active table
NDC11SourceActive
21922004340rxnav_ndcsyes
68308077750rxnav_ndcsyes
68682051595rxnav_ndcsyes
69238232301rxnav_ndcsyes
72162230302rxnav_ndcsyes

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 · 6 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TretinoinTRETINOINAmneal Pharmaceuticals NY LLC4b6006e3-f7a4-4823-8217-3e5b0f7e58d92026-04-29Warnings, Adverse reactionsExact identifier
ndc (package): 69238-2323-1
ndc (product): 69238-2323
ndc11 (package): 69238232301
rxcui: 1488045
TRETINOINTRETINOINEncube Ethicals, Inc.57558405-42fa-40bb-a61c-48e030d976de2026-04-16Warnings, Adverse reactionsExact identifier
ndc (package): 21922-043-40
ndc (product): 21922-043
ndc11 (package): 21922004340
rxcui: 1488045
TretinoinTRETINOINBryant Ranch Prepack2b58cf56-e713-4cdd-8b4e-e6651ef766502026-03-04Warnings, Adverse reactionsExact identifier
ndc (package): 72162-2303-2
ndc (product): 72162-2303
ndc11 (package): 72162230302
rxcui: 1488045
TretinoinTRETINOINOceanside Pharmaceuticalsd3c528d2-429d-4f37-9ebf-eee8b9fd30502025-09-30Warnings, Adverse reactionsExact identifier
ndc (package): 68682-515-95
ndc (product): 68682-515
ndc11 (package): 68682051595
rxcui: 1488045
Retin-A MICROTRETINOINBausch Health US LLC08ab7e0c-1437-455f-815c-98904d96a2892025-09-01Warnings, Adverse reactionsExact identifier
rxcui: 1488045
Tretinoin (Microsphere)TRETINOINMayne Pharmaed2103ee-c9d5-4b3d-b525-318cf67be0502024-10-28Warnings, Adverse reactionsExact identifier
ndc (package): 68308-777-50
ndc (product): 68308-777
ndc11 (package): 68308077750
rxcui: 1488045

DailyMed RxNorm Mappings#

unique DailyMed labels mapped to this RxNorm concept page 1 of 1 · 6 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
2b58cf56-e713-4cdd-8b4e-e6651ef76650tretinoin 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [SCD] · tretinoin 0.08 % Topical Gel [SY]3101These highlights do not include all the information needed to use TRETINOIN GEL (MICROSPHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere), for topical use Initial U.S. Approval: 197120260304
08ab7e0c-1437-455f-815c-98904d96a289tretinoin 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [SCD] · tretinoin 0.08 % Topical Gel [SY]323These highlights do not include all the information needed to use RETIN-A MICRO safely and effectively. See full prescribing information for RETIN-A MICRO. RETIN-A MICRO ® (tretinoin) gel, for topical use Initial U.S. Approval: 197120250901
d3c528d2-429d-4f37-9ebf-eee8b9fd3050tretinoin 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [SCD] · tretinoin 0.08 % Topical Gel [SY]313These highlights do not include all the information needed to use TRETINOIN GEL MICROSPHERE safely and effectively. See full prescribing information for TRETINOIN GEL MICROSPHERE. TRETINOIN gel microsphere, for topical use Initial U.S. Approval: 197120250930
4b6006e3-f7a4-4823-8217-3e5b0f7e58d9tretinoin 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [SCD] · tretinoin 0.08 % Topical Gel [SY]37These highlights do not include all the information needed to use TRETINOIN GEL (MICROSPHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere), for topical use Initial U.S. Approval: 197120260429
57558405-42fa-40bb-a61c-48e030d976detretinoin 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [SCD] · tretinoin 0.08 % Topical Gel [SY]35These highlights do not include all the information needed to use TRETINOIN GEL (MICROSPHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere) 0.08% and 0.06%, for topical use Initial U.S. Approval: 197120260416
ed2103ee-c9d5-4b3d-b525-318cf67be050tretinoin 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [SCD] · tretinoin 0.08 % Topical Gel [SY]31These highlights do not include all the information needed to use TRETINOIN GEL (MICROSHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere), for topical use. Initial U.S. Approval: 197120241028

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4b6006e3-f7a4-4823-8217-3e5b0f7e58d9These highlights do not include all the information needed to use TRETINOIN GEL (MICROSPHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere), for topical use Initial U.S. Approval: 1971Amneal Pharmaceuticals NY LLC | Amneal Pharmaceuticals, LLC20260429
57558405-42fa-40bb-a61c-48e030d976deThese highlights do not include all the information needed to use TRETINOIN GEL (MICROSPHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere) 0.08% and 0.06%, for topical use Initial U.S. Approval: 1971Encube Ethicals, Inc. | Encube Ethicals Private Limited20260416
2b58cf56-e713-4cdd-8b4e-e6651ef76650These highlights do not include all the information needed to use TRETINOIN GEL (MICROSPHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere), for topical use Initial U.S. Approval: 1971Bryant Ranch Prepack20260304
d3c528d2-429d-4f37-9ebf-eee8b9fd3050These highlights do not include all the information needed to use TRETINOIN GEL MICROSPHERE safely and effectively. See full prescribing information for TRETINOIN GEL MICROSPHERE. TRETINOIN gel microsphere, for topical use Initial U.S. Approval: 1971Oceanside Pharmaceuticals | Bausch Health Companies Inc.20250930
ed2103ee-c9d5-4b3d-b525-318cf67be050These highlights do not include all the information needed to use TRETINOIN GEL (MICROSHERE) safely and effectively. See full prescribing information for TRETINOIN GEL (MICROSPHERE). TRETINOIN gel (microsphere), for topical use. Initial U.S. Approval: 1971Mayne Pharma | Encube Ethicals Private Limited20241028

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCL01XFRetinoids for cancer treatmentATC1-4tretinoin
ATCD10ADRetinoids for topical use in acneATC1-4tretinoin
FDASPLD012176RetinoidsCHEMhas_chemical_structuretretinoin
FDASPLN0000175607RetinoidEPChas_epctretinoin
MEDRTD010226ParabensCHEMci_chemclasstretinoin
MEDRTD014212TretinoinCHEMhas_ingredienttretinoin
MEDRTD000152Acne VulgarisDISEASEmay_treattretinoin
MEDRTD004342Drug HypersensitivityDISEASEci_withtretinoin
MEDRTD005148Facial DermatosesDISEASEmay_treattretinoin
MEDRTD017495HyperpigmentationDISEASEmay_treattretinoin
MEDRTD015473Leukemia, Promyelocytic, AcuteDISEASEmay_treattretinoin
MEDRTD011247PregnancyDISEASEci_withtretinoin
MEDRTN0000000085Receptor InteractionsMOAhas_moatretinoin
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moatretinoin
MEDRTN0000175676Decreased Epithelial ProliferationPEhas_petretinoin
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_petretinoin
MEDRTN0000009979Decreased Sebaceous Gland QuantityPEhas_petretinoin

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.0008 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESANDAANDA215609
CODESANDAANDA217497
CODESVUID4033378
NAMESPrescribable Synonymtretinoin 0.08 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon
SOURCESSourceNational Drug Data File Plus Source Vocabulary
SOURCESSourceVeterans Health Administration National Drug File