FDA.reportPublic FDA data

tretinoin 0.0008 MG/MG Topical Gel [Retin-A]

RxCUI
1488047
RxNorm name
tretinoin 0.0008 MG/MG Topical Gel [Retin-A]
Display name
RETIN-A (Topical)
Full name
tretinoin 0.0008 MG/MG Topical Gel [Retin-A]
Term type
SBD
Status
Active
Strength
0.08%
Dose form
Gel
Route
Topical
Updated
2026-08-12 12:30:53

RxNorm Status History#

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

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_STRRetin-A 0.08 % Topical Gel1NAMES
RxNorm Nametretinoin 0.0008 MG/MG Topical Gel [Retin-A]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID08ab7e0c-1437-455f-815c-98904d96a2891CODES
RxCUI14880471CODES
MMSL_CODEBD296291CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0187-5148-020187-5148Retin-A MICRO TretinoinBausch Health US LLCNDA020475
0187-5148-500187-5148Retin-A MICRO TretinoinBausch Health US LLCNDA020475

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0204750187-5148Retin-A MICRO TretinoinNDABausch Health US LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 2 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00187514802rxnav_ndcsyes
00187514850rxnav_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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Retin-A MICROTRETINOINBausch Health US LLC08ab7e0c-1437-455f-815c-98904d96a2892025-09-01Warnings, Adverse reactionsExact identifier
ndc (package): 0187-5148-02
ndc (package): 0187-5148-50
ndc (product): 0187-5148
ndc11 (package): 00187514802
ndc11 (package): 00187514850
rxcui: 1488047

DailyMed RxNorm Mappings#

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

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
08ab7e0c-1437-455f-815c-98904d96a289RETIN-A MICRO 0.08 % Topical Gel [PSN] · tretinoin 0.0008 MG/MG Topical Gel [Retin-A] [SBD] · Retin-A 0.0008 MG/MG Topical Gel [SY] · Retin-A 0.08 % Topical Gel [SY] · Retin-A Micro 0.08 % Topical Gel [SY]523These 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

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
08ab7e0c-1437-455f-815c-98904d96a289These 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: 1971Bausch Health US LLC | Bausch Health Companies Inc.20250901

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
CODESNDANDA020475
NAMESPrescribable SynonymRETIN-A MICRO 0.08 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon