Oil-Free Acne Cleanser

Product NDC
50544-001
11-digit product format
505440001
Labeler code
50544
Product ID
50544-001_038390ce-8684-4c27-98dc-9521d0e3964b
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
CREAM
Route
TOPICAL
Labeler
University Medical Pharmaceuticals Corp
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2011-11-01
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
3 g/100g
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50544-001-062019-11-13C16284748780-197449f38-b8b2-f6ea-e053-dbdaa90aa703Oil-Free Acne Cleanser

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50544-001-06Oil-Free Acne Cleanser237 g in 1 BOTTLE, PLASTICCREAM2371

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
benzoic acidACTIVE MOIETY8SKN0B0MIMOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
BENZALKONIUM CHLORIDEINACTIVE INGREDIENTF5UM2KM3W7OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
CETYL ALCOHOLINACTIVE INGREDIENT936JST6JCNOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GUOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
COCAMIDOPROPYL BETAINEINACTIVE INGREDIENT5OCF3O11KXOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7EOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
ETHYLHEXYLGLYCERININACTIVE INGREDIENT147D247K3POIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE4OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR7OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
MAGNESIUM ALUMINUM SILICATEINACTIVE INGREDIENT6M3P64V0NCOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
MATRICARIA RECUTITAINACTIVE INGREDIENTG0R4UBI2ZZOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
MEDIUM-CHAIN TRIGLYCERIDESINACTIVE INGREDIENTC9H2L21V7UOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
METHYLISOTHIAZOLINONEINACTIVE INGREDIENT229D0E1QFAOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
PEG-100 STEARATEINACTIVE INGREDIENTYD01N1999ROIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
PSEUDOPTEROGORGIA ELISABETHAEINACTIVE INGREDIENTUDY3H1OUX5OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EUOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65APOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
waterINACTIVE INGREDIENT059QF0KO0ROIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1
XANTHAN GUMINACTIVE INGREDIENTTTV12P4NEEOIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50544-001OIL-FREE ACNE CLEANSER (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP]1Legacy NDC, 1 package rows20111102_3e284042-8054-47c3-8051-e16782bf6d8c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
308688benzoyl peroxide 2.5 % Topical CreamPSN3e284042-8054-47c3-8051-e16782bf6d8c1
308688benzoyl peroxide 25 MG/ML Topical CreamSCD3e284042-8054-47c3-8051-e16782bf6d8c1
308688benzoyl peroxide 2.5 % Topical CreamSY3e284042-8054-47c3-8051-e16782bf6d8c1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
50544-001-0650544000106237 g in 1 BOTTLE, PLASTIC237 gHistorical