FDA.reportPublic FDA data

3 Step Acne System

Product NDC
0363-3226
11-digit product format
003633226
Labeler code
0363
Product ID
0363-3226_2c791796-51a2-4d1b-ae9a-14e16b5d5b79
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
KIT
Labeler
Walgreens
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-07-15
Marketing end
0000-00-00
Active strength
0
NDC exclude flag
No
Listing certified through
2019-12-31
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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0363-3226-072020-01-31C16284748780-19d75b9d0-ee39-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-3226-073 Step Acne SystemWell at Walgreens1 in 1 KITKIT12
0363-3227-043 Step Acne SystemWell at Walgreens120 mL in 1 BOTTLELOTION120 mL2.5 g in 100mL2
0363-3228-023 Step Acne SystemWell at Walgreens60 mL in 1 BOTTLELOTION60 mL2.5 g in 100mL2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GM3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
AllantoinINACTIVE INGREDIENT344S277G0Z3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)INACTIVE INGREDIENT59TL3WG5CO3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
CETYL ESTERS WAXINACTIVE INGREDIENTD072FFP9GU3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
CHAMAEMELUM NOBILE FLOWERINACTIVE INGREDIENTO2T154T6OG3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
CYCLOMETHICONE 4INACTIVE INGREDIENTCZ227117JE3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0R3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Diazolidinyl UreaINACTIVE INGREDIENTH5RIZ3MPW43 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
DIETHYLENE GLYCOL MONOETHYL ETHERINACTIVE INGREDIENTA1A1I8X02B3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
DimethiconeINACTIVE INGREDIENT92RU3N3Y1O3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Dimethyl IsosorbideINACTIVE INGREDIENTSA6A6V432S3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
GLYCERYL MONOSTEARATEINACTIVE INGREDIENT230OU9XXE43 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
HIGH DENSITY POLYETHYLENEINACTIVE INGREDIENTUG00KM4WR73 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
IMIDUREAINACTIVE INGREDIENTM629807ATL3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Magnesium Aluminum SilicateINACTIVE INGREDIENT6M3P64V0NC3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Neopentyl Glycol Dicaprylate/DicaprateINACTIVE INGREDIENTVLW429K27K3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
PanthenolINACTIVE INGREDIENTWV9CM0O67Z3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
PEG-100 StearateINACTIVE INGREDIENTYD01N1999R3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUY3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V33 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OH3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
SODIUM PYRROLIDONE CARBOXYLATEINACTIVE INGREDIENT469OTG57A23 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
SorbitolINACTIVE INGREDIENT506T60A25R3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
SUCCINIC ACIDINACTIVE INGREDIENTAB6MNQ6J6L3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Tridecyl StearateINACTIVE INGREDIENTA8OE252M6L3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Tridecyl TrimellitateINACTIVE INGREDIENTFY36J270ES3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
WaterINACTIVE INGREDIENT059QF0KO0R3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEE3 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-32263 STEP ACNE SYSTEM WELL AT WALGREENS (BENZOYL PEROXIDE) KIT [WALGREENS]2Legacy NDC, 3 package rows20180223_eddc5d88-7812-49f6-b1c0-a12230e2528c.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1600267{1 (120 ML) (benzoyl peroxide 25 MG/ML Medicated Liquid Soap) / 1 (60 ML) (benzoyl peroxide 25 MG/ML Topical Lotion) } PackGPCKeddc5d88-7812-49f6-b1c0-a12230e2528c2
1600267benzoyl peroxide 2.5 % / 2.5 % Topical KitPSNeddc5d88-7812-49f6-b1c0-a12230e2528c2
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSNeddc5d88-7812-49f6-b1c0-a12230e2528c2
200009benzoyl peroxide 2.5 % Topical LotionPSNeddc5d88-7812-49f6-b1c0-a12230e2528c2
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCDeddc5d88-7812-49f6-b1c0-a12230e2528c2
200009benzoyl peroxide 25 MG/ML Topical LotionSCDeddc5d88-7812-49f6-b1c0-a12230e2528c2
1600267{1 (120 ML) (benzoyl peroxide 2.5 % Medicated Liquid Soap) / 1 (60 ML) (benzoyl peroxide 2.5 % Topical Lotion) } PackSYeddc5d88-7812-49f6-b1c0-a12230e2528c2
845836benzoyl peroxide 2.5 % Medicated Liquid SoapSYeddc5d88-7812-49f6-b1c0-a12230e2528c2
200009benzoyl peroxide 2.5 % Topical LotionSYeddc5d88-7812-49f6-b1c0-a12230e2528c2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
0363-3226-07003633226071 in 1 KITHistorical
0363-3227-0400363322704120 mL in 1 BOTTLE120 mlHistorical
0363-3228-020036332280260 mL in 1 BOTTLE60 mlHistorical