FDA.reportPublic FDA data

azelaic acid 0.15 MG/MG Topical Gel [Finacea]

RxCUI
1043748
RxNorm name
azelaic acid 0.15 MG/MG Topical Gel [Finacea]
Display name
FINACEA (Topical)
Full name
azelaic acid 0.15 MG/MG Topical Gel [Finacea]
Term type
SBD
Status
Active
Strength
15%
Dose form
Gel
Route
Topical
Updated
2026-10-27 17:47:30

RxNorm Status History#

Status
Active
Source
RXNORM
Current
YES
Release start
122010
Active start
122010
Multiple ingredient
NO
Branded
YES

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
azelaic acid0.15 MG / 1 MGazelateazelaic acid

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Gel346286

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
azelate618278

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRFinacea 15 % Topical Gel1NAMES
RxNorm Nameazelaic acid 0.15 MG/MG Topical Gel [Finacea]1NAMES
RxNorm Synonym
3 linked values
3NAMES
TTYSBD1ATTRIBUTES
SPL_SET_ID63773349-0295-4d56-a72e-0d7cade88ddb1CODES
RxCUI10437481CODES
MMSL_CODE
2 linked values
2CODES

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 20 matching rows.

NDC11, Source, Active table
NDC11SourceActive
50090303200rxnav_ndcsyes
50090447300rxnav_ndcsyes
50222050550rxnav_ndcsyes
10922082502rxnav_historical
10922082571rxnav_historical_indirect
10922082610rxnav_historical
35356022750rxnav_historical
50222050591rxnav_historical
50419082501rxnav_historical
50419082502rxnav_historical
50419082503rxnav_historical
50419082571rxnav_historical
50419082574rxnav_historical
54569629000rxnav_historical
54868523600rxnav_historical
54868523601rxnav_historical
58118995005rxnav_historical
66194082501rxnav_historical
66194082502rxnav_historical
66194082503rxnav_historical

UNII Substances#

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

No records found.

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 · 3 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
63773349-0295-4d56-a72e-0d7cade88ddbFinacea 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [Finacea] [SBD] · Finacea 0.15 MG/MG Topical Gel [SY] · Finacea 15 % Topical Gel [SY] · Finacea Plus (azelaic acid 0.15 MG/MG) Topical Gel [SY]55Finacea ® (azelaic acid) Gel, 15%20110412
9f40cd45-58a6-4376-9220-84bfe7d7e358Finacea 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [Finacea] [SBD] · Finacea 0.15 MG/MG Topical Gel [SY] · Finacea 15 % Topical Gel [SY] · Finacea Plus (azelaic acid 0.15 MG/MG) Topical Gel [SY]53These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 199520200118
6c5e836c-2851-4524-b91d-12ffadffd9baFinacea 15 % Topical Gel [PSN] · azelaic acid 0.15 MG/MG Topical Gel [Finacea] [SBD] · Finacea 0.15 MG/MG Topical Gel [SY] · Finacea 15 % Topical Gel [SY] · Finacea Plus (azelaic acid 0.15 MG/MG) Topical Gel [SY]5120100831

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
bea1957c-55ca-48cd-8cbc-ed44d546a857These highlights do not include all the information needed to use FINACEA Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) gel, for topical use Initial U.S. Approval: 1995LEO Pharma, Inc | Leo Pharma Manufacturing Italy SRL.20251125
89ab8a10-bead-465c-9f24-02afa5aaec3cThese highlights do not include all the information needed to use FINACEA Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) gel, for topical use Initial U.S. Approval: 1995A-S Medication Solutions20250106
9f40cd45-58a6-4376-9220-84bfe7d7e358These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995A-S Medication Solutions20200118
c7c5af9c-935e-440d-a625-567936e0bae7These highlights do not include all the information needed to use FINACEA ® Gel safely and effectively. See full prescribing information for FINACEA Gel. FINACEA ® (azelaic acid) Gel, 15% for topical use Initial U.S. Approval: 1995Bayer HealthCare Pharmaceuticals Inc. | Leo Pharma Manufacturing Italy SRL20190723
5fc1cab0-2057-4585-a181-55457be4c4d2National Council for Prescription Drug Programs20130604
cc88c1c6-579a-4dbd-b4ae-ffd456903c1eNational Council for Prescription Drug Programs20130401
28b9e18c-6bad-4460-8668-b4bacae42711National Council for Prescription Drug Programs20120724
86050828-5e8f-4bf5-ac59-897918611e0fNational Council for Prescription Drug Programs20120724
63773349-0295-4d56-a72e-0d7cade88ddbFinacea ® (azelaic acid) Gel, 15%Intendis Inc. | Intendis Manufacturing SPA20110412
6c5e836c-2851-4524-b91d-12ffadffd9baPhysicians Total Care, Inc.20100831

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD10AXOther anti-acne preparations for topical useATC1-4azelaic acid
FDASPLN0000008841Decreased Protein SynthesisPEhas_peazelaic acid
FDASPLN0000009982Decreased Sebaceous Gland ActivityPEhas_peazelaic acid
MEDRTD003998Dicarboxylic AcidsCHEMhas_ingredientazelaic acid
MEDRTD000152Acne VulgarisDISEASEmay_treatazelaic acid
MEDRTD004342Drug HypersensitivityDISEASEci_withazelaic acid
MEDRTD012393RosaceaDISEASEmay_treatazelaic acid
MEDRTN0000009915Unknown Cellular or Molecular InteractionMOAhas_moaazelaic acid
MEDRTN0000008841Decreased Protein SynthesisPEhas_peazelaic acid
MEDRTN0000009982Decreased Sebaceous Gland ActivityPEhas_peazelaic acid

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH0.15 MG/MG (expressed as azelaic acid)
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESNDANDA021470
NAMESPrescribable SynonymFinacea 15 % Topical Gel
SOURCESSourceGold Standard Alchemy
SOURCESSourceMetathesaurus FDA Structured Product Labels
SOURCESSourceMicromedex RED BOOK
SOURCESSourceMultum MediSource Lexicon