FDA.reportPublic FDA data

urea 200 MG/ML Topical Cream

RxCUI
198886
RxNorm name
urea 200 MG/ML Topical Cream
Display name
Urea (Topical)
Full name
urea 200 MG/ML Topical Cream
Term type
SCD
Status
Active
Strength
20%
Dose form
Cream
Route
Topical
Updated
2026-11-02 22:17:35

RxNorm Status History#

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

Ingredients And Strength#

Ingredient, Strength, Base table
IngredientStrengthBaseBasis of strength
urea200 MG / 1 MLureaurea

Dose Form Concepts#

Dose form, RxCUI table
Dose formRxCUI
Topical Cream316982

Derived Ingredient Concepts#

Ingredient, RxCUI table
IngredientRxCUI
urea11002

Source Vocabulary Codes#

Code type, Values, Count table
Code typeValuesCountCategory
PRESCRIBABLEY1ATTRIBUTES
RXNAV_STRurea 200 MG/ML Topical Cream1NAMES
RxNorm Nameurea 200 MG/ML Topical Cream1NAMES
RxNorm Synonym
2 linked values
2NAMES
TTYSCD1ATTRIBUTES
SPL_SET_ID
7 linked values
7CODES
RxCUI1988861CODES
MMSL_CODE
3 linked values
3CODES

FDA NDC Products And Packages#

Package NDC, Product NDC, Name table
Package NDCProduct NDCNameLabelerApplication
44523-618-0344523-618UREA UREABioComp Pharma, Inc.
50268-820-8550268-820Urea 20 UreaAvPAK
59088-257-0859088-257Uracin 20% Urea 20%PureTek Corporation
59088-257-1659088-257Uracin 20% Urea 20%PureTek Corporation
59088-258-1659088-258Urea 20% Urea 20%PureTek Corporation
85622-601-0385622-601UREDEX UREABlue Heron Pharmaceuticals, LLC

RxNav Current And Historical NDCs#

RxNav current and historical NDC rows page 1 of 1 · 43 matching rows.

NDC11, Source, Active table
NDC11SourceActive
00536110945rxnav_ndcsyes
31064060259rxnav_ndcsyes
31064060262rxnav_ndcsyes
31064076002rxnav_ndcsyes
31064076028rxnav_ndcsyes
44523061803rxnav_ndcsyes
50268082085rxnav_ndcsyes
58980061030rxnav_ndcsyes
59088025708rxnav_ndcsyes
59088025716rxnav_ndcsyes
59088025816rxnav_ndcsyes
85622060103rxnav_ndcsyes
85622060503rxnav_ndcsyes
00033265119rxnav_historical
00033265120rxnav_historical
00884044903rxnav_historical
00884044904rxnav_historical
10337065119rxnav_historical
10481300101rxnav_historical
10481300102rxnav_historical
10481300103rxnav_historical
10481300104rxnav_historical
10481300105rxnav_historical
10481300106rxnav_historical
10481300116rxnav_historical
13613023001rxnav_historical
45802020903rxnav_historical
45802020944rxnav_historical
47854078004rxnav_historical
54162067203rxnav_historical
54162067214rxnav_historical
54868621600rxnav_historical
58980061040rxnav_historical
61344045525rxnav_historical
61344045550rxnav_historical
71399843403rxnav_historical
83720056101rxnav_historical
83720056103rxnav_historical
83720056107rxnav_historical
84844000901rxnav_historical
84844001001rxnav_historical
92771067201rxnav_historical
92771067203rxnav_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 · 4 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
UREDEXUREABlue Heron Pharmaceuticals, LLC0e4d7b03-527f-4cff-9154-7e5e485a8f802026-07-13Warnings, Adverse reactionsExact identifier
ndc (package): 85622-601-03
ndc (product): 85622-601
ndc11 (package): 85622060103
rxcui: 198886
UREVEXUREABlue Heron Pharmaceuticals, LLC1ed71529-7607-47ff-bd16-3c9a63e1c7332026-04-28Warnings, Adverse reactionsExact identifier
ndc11 (package): 85622060503
rxcui: 198886
UREAUREABioComp Pharma, Inc.0fb373f8-5328-2f10-e063-6294a90a24842026-01-13Warnings, Adverse reactionsExact identifier
ndc (package): 44523-618-03
ndc (product): 44523-618
ndc11 (package): 44523061803
rxcui: 198886
Urea 20UREAAvPAKe994fa05-a457-2555-e053-2a95a90ae83b2026-01-12WarningsExact identifier
ndc (package): 50268-820-85
ndc (product): 50268-820
ndc11 (package): 50268082085

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 · 8 matching rows.

Set ID, RxNorm mappings, Terms table
Set IDRxNorm mappingsTermsSPL versionLabelEffective
4305c057-bd6f-bb58-e063-6294a90abe75urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]45Uracin 20% Cream Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.20260220
0e4d7b03-527f-4cff-9154-7e5e485a8f80urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]42Uredex20260116
0fb373f8-5328-2f10-e063-6294a90a2484urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]42Urea 20% Cream20260113
136cb37e-e939-40b5-9725-194b14a9b090urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]42NOXIPAK KIT20171108
1ed71529-7607-47ff-bd16-3c9a63e1c733urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]41Urevex 20%20260428
2626332f-27be-f900-e063-6394a90a29c3urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]4184844-00920241105
2626c884-67ad-52ac-e063-6394a90a5ad9urea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]4184844-01020241105
ebd520d0-8069-490f-a0d7-356d1e7c3dfdurea 20 % Topical Cream [PSN] · urea 200 MG/ML Topical Cream [SCD] · urea 17 GM in 85 GM Topical Cream [SY] · urea 20 % Topical Cream [SY]41Podiatrole20230106

Recently Linked DailyMed Labels#

Set ID, Title, Manufacturer table
Set IDTitleManufacturerEffective
4305c057-bd6f-bb58-e063-6294a90abe75Uracin 20% Cream Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.PureTek Corporation20261006
5c056c44-9ffb-b029-e063-6394a90a7fc6Urea 20% Cream Rx Only For external use only. Not for ophthalmic use.PureTek Corporation20261006
0e4d7b03-527f-4cff-9154-7e5e485a8f80UredexBlue Heron Pharmaceuticals, LLC | Mission Pharmacal20260713
1ed71529-7607-47ff-bd16-3c9a63e1c733Urevex 20%Blue Heron Pharmaceuticals, LLC | Mission Pharmacal20260428
4305c057-bd6f-bb58-e063-6294a90abe75Uracin 20% Cream Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.PureTek Corporation20260220
4305c057-bd6f-bb58-e063-6294a90abe75Uracin 20% Cream Rx only FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.PureTek Corporation20260220
0e4d7b03-527f-4cff-9154-7e5e485a8f80UredexBlue Heron Pharmaceuticals, LLC | Mission Pharmacal20260116
0fb373f8-5328-2f10-e063-6294a90a2484Urea 20% CreamBioComp Pharma, Inc. | Mission Pharmacal Company20260113
e994fa05-a457-2555-e053-2a95a90ae83bUrea 20% CreamAvPAK20260112
0e4d7b03-527f-4cff-9154-7e5e485a8f80UrevexBlue Heron Pharmaceuticals, LLC | Mission Pharmacal20260107
2626c884-67ad-52ac-e063-6394a90a5ad984844-010Guoyu Trading Co., Ltd.20241105
2626332f-27be-f900-e063-6394a90a29c384844-009Guoyu Trading Co., Ltd.20241105
2505714f-4d96-4456-a831-7cf304b15682Urea 20% CreamOncor Pharmaceuticals20240510
982e54c8-7c17-44fe-b05b-d3df03c45493MEDPURA Urea 20 Intensive Hydrating CreamAkron Pharma Inc.20231208
8a2f32ae-cbb7-4fc0-e053-2995a90ab374Uremol 20% CreamOdan Laboratories Ltd20231120
136cb37e-e939-40b5-9725-194b14a9b090NOXIPAK KITSOLUTECH PHARMACEUTICALS LLC20171108
46e2544d-8249-446c-8236-0a0dc2db4144National Council for Prescription Drug Programs20120724
5b4999af-dec3-44ce-aa17-36b35674f8fbNational Council for Prescription Drug Programs20120724

Drug Classes#

Source, Class ID, Class table
SourceClass IDClassTypeRelationshipDrug concept
ATCD02AECarbamide productsATC1-4urea
ATCB05BCSolutions producing osmotic diuresisATC1-4urea
MEDRTD014508UreaCHEMhas_ingredienturea
MEDRTD004342Drug HypersensitivityDISEASEci_withurea
MEDRTD017488Hyperkeratosis, EpidermolyticDISEASEmay_treaturea
MEDRTD019586Intracranial HypertensionDISEASEmay_treaturea
MEDRTD009798Ocular HypertensionDISEASEmay_treaturea
MEDRTN0000000065Physiochemical ActivityMOAhas_moaurea
MEDRTN0000009035Emollient ActivityPEhas_peurea
MEDRTN0000010240Increased Renal Urea ExcretionPEhas_peurea

Properties#

Category, Property, Value table
CategoryPropertyValue
ATTRIBUTESAVAILABLE_STRENGTH200 MG/ML
ATTRIBUTESGENERAL_CARDINALITYSINGLE
ATTRIBUTESHUMAN_DRUGUS
ATTRIBUTESRXNAV_HUMAN_DRUGUS
ATTRIBUTESSCHEDULE0
CODESVUID4006053
NAMESPrescribable Synonymurea 20 % Topical Cream
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