FDA.reportPublic FDA data

tretinoin 0.0001 MG/MG Topical Gel [Retin-A]

RxCUI
208334
RxNorm name
tretinoin 0.0001 MG/MG Topical Gel [Retin-A]
Display name
RETIN-A (Topical)
Full name
tretinoin 0.0001 MG/MG Topical Gel [Retin-A]
Term type
SBD
Status
Active
Strength
0.01%
Dose form
Gel
Route
Topical
Updated
2026-11-08 10:18:56

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
tretinoin0.0001 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 0.01 % Topical Gel1NAMES
RxNorm Nametretinoin 0.0001 MG/MG Topical Gel [Retin-A]1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID9556d73d-c573-4e0a-9feb-764ce2d1107b1CODES
RxCUI2083341CODES
MMSL_CODEBD31661CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
0187-5172-150187-5172Retin-A TretinoinBausch Health US, LLCNDA017955
0187-5172-450187-5172Retin-A TretinoinBausch Health US, LLCNDA017955

Drugs@FDA Applications#

Application, NDC, Name table
ApplicationNDCNameMarketing categoryLabeler
NDA0179550187-5172Retin-A TretinoinNDABausch Health US, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 16 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00187517215rxnav_ndcsyes
00187517245rxnav_ndcsyes
00062019011rxnav_historical
00062057544rxnav_historical
00062057546rxnav_historical
00062057549rxnav_historical
00107057544rxnav_historical
00107057546rxnav_historical
00187514020rxnav_historical
00187514045rxnav_historical
00187514050rxnav_historical
00247025515rxnav_historical
53002099663rxnav_historical
54569107900rxnav_historical
54868026902rxnav_historical
58016307501rxnav_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
Retin-A MICROTRETINOINBausch Health US LLC08ab7e0c-1437-455f-815c-98904d96a2892025-09-01Warnings, Adverse reactionsExact identifier
ndc11 (package): 00187514045
ndc11 (package): 00187514050
ndc11 (package): 00187514020
Retin-ATRETINOINBausch Health US, LLC9556d73d-c573-4e0a-9feb-764ce2d1107b2024-05-17Adverse reactionsExact identifier
ndc (package): 0187-5172-45
ndc (package): 0187-5172-15
ndc (product): 0187-5172
ndc11 (package): 00187517215
ndc11 (package): 00187517245
rxcui: 208334

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 · 2 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
9556d73d-c573-4e0a-9feb-764ce2d1107bRetin-A 0.01 % Topical Gel [PSN] · tretinoin 0.0001 MG/MG Topical Gel [Retin-A] [SBD] · Retin-A 0.0001 MG/MG Topical Gel [SY] · Retin-A 0.01 % Topical Gel [SY]415Retin-A ® (tretinoin) Cream • Gel20240517
0ee4fccd-087f-4134-9b66-1d5186c116c0Retin-A 0.01 % Topical Gel [PSN] · tretinoin 0.0001 MG/MG Topical Gel [Retin-A] [SBD] · Retin-A 0.0001 MG/MG Topical Gel [SY] · Retin-A 0.01 % Topical Gel [SY]4120100427

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
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
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
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 microsphere, 0.1%, 0.08%, 0.06% and 0.04%, for topical use Initial U.S. Approval: 1971Bausch Health US LLC | Bausch Health Companies Inc.20250430
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 microsphere, 0.1%, 0.08%, 0.06% and 0.04%, for topical use Initial U.S. Approval: 1971Bausch Health US LLC | Bausch Health Companies Inc.20250430
9556d73d-c573-4e0a-9feb-764ce2d1107bRetin-A ® (tretinoin) Cream • GelBausch Health US, LLC | Bausch Health Companies Inc.20240517
6b8d1210-4c03-4e2b-b795-4bca45e376a0National Council for Prescription Drug Programs20120724
7e47a34f-5a7e-4e65-9961-e011c1f62e3fNational Council for Prescription Drug Programs20120724
d574bd9e-5697-4406-9d8b-3dc717da6325National Council for Prescription Drug Programs20120724
edadf8ac-e329-4174-8597-0658af9297beNational Council for Prescription Drug Programs20120724
0ee4fccd-087f-4134-9b66-1d5186c116c0Physicians Total Care, Inc.20100427

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_STRENGTH0.0001 MG/MG
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA017955
NAMESPrescribable SynonymRetin-A 0.01 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon