Breakout Clearing Emergency Spot Fix

Product NDC
68479-202
11-digit product format
684790202
Labeler code
68479
Product ID
68479-202_a428575c-cefa-4f1d-8712-faf36371ae8c
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
LOTION
Route
TOPICAL
Labeler
Dermalogica, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2013-06-03
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
50 mg/mL
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
68479-202-002020-01-31C16284748780-19d75b9d0-4a20-f424-e053-dadaa90a57ceBreakout Clearing Emergency Spot Fix
68479-202-022020-01-31C16284748780-19d75b9d0-4a20-f424-e053-dadaa90a57ceBreakout Clearing Emergency Spot Fix

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68479-202-00Breakout Clearing Emergency Spot Fix2 mL in 1 POUCHLOTION21
68479-202-02Breakout Clearing Emergency Spot Fix1 in 1 CARTONLOTION11
68479-202-02Breakout Clearing Emergency Spot Fix9 mL in 1 TUBELOTION91

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Benzoyl PeroxideACTIVE INGREDIENTW9WZN9A0GMBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Benzoyl PeroxideACTIVE MOIETYW9WZN9A0GMBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
AminomethylpropanolINACTIVE INGREDIENTLU49E6626QBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Annickia Chlorantha BarkINACTIVE INGREDIENTH70115MP4ABREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Butylene GlycolINACTIVE INGREDIENT3XUS85K0RABREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Carbomer Interpolymer Type A (Allyl Sucrose Crosslinked)INACTIVE INGREDIENT59TL3WG5COBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Cetyl AlcoholINACTIVE INGREDIENT936JST6JCNBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
EthylhexylglycerinINACTIVE INGREDIENT147D247K3PBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Filipendula Ulmaria RootINACTIVE INGREDIENT997724QNDSBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Glyceryl MonostearateINACTIVE INGREDIENT230OU9XXE4BREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Glycyrrhiza GlabraINACTIVE INGREDIENT2788Z9758HBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Green Tea LeafINACTIVE INGREDIENTW2ZU1RY8B0BREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Lavandula Angustifolia Flowering TopINACTIVE INGREDIENT9YT4B71U8PBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Medium-Chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Oleanolic AcidINACTIVE INGREDIENT6SMK8R7TGJBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Polyethylene Glycol 400INACTIVE INGREDIENTB697894SGQBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Polysorbate 80INACTIVE INGREDIENT6OZP39ZG8HBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Porphyra UmbilicalisINACTIVE INGREDIENT14AN0J70WOBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Sodium Acrylate/Sodium Acryloyldimethyltaurate Copolymer (4000000 MW)INACTIVE INGREDIENT1DXE3F3OZXBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Tea Tree OilINACTIVE INGREDIENTVIF565UC2GBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1
Xanthan GumINACTIVE INGREDIENTTTV12P4NEEBREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68479-202BREAKOUT CLEARING EMERGENCY SPOT FIX (BENZOYL PEROXIDE) LOTION [DERMALOGICA, INC.]1Legacy NDC, 3 package rows20140215_f1db1790-822e-41b3-af4d-1e28387c090d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106309benzoyl peroxide 5 % Topical LotionPSNf1db1790-822e-41b3-af4d-1e28387c090d1
1489215Clear Start Emergency Spot Fix 5 % Topical LotionPSNf1db1790-822e-41b3-af4d-1e28387c090d1
1489215benzoyl peroxide 50 MG/ML Topical Lotion [Clear Start Emergency Spot Fix]SBDf1db1790-822e-41b3-af4d-1e28387c090d1
106309benzoyl peroxide 50 MG/ML Topical LotionSCDf1db1790-822e-41b3-af4d-1e28387c090d1
106309benzoyl peroxide 5 % Topical LotionSYf1db1790-822e-41b3-af4d-1e28387c090d1
1489215Clear Start Emergency Spot Fix 5 % Topical LotionSYf1db1790-822e-41b3-af4d-1e28387c090d1
1489215Dermalogica Clear Start Breakout Clearing 5 % Topical LotionSYf1db1790-822e-41b3-af4d-1e28387c090d1
1489215Dermalogica Emergency Spot Fix 5 % Topical LotionSYf1db1790-822e-41b3-af4d-1e28387c090d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsStatus
68479-202-00684790202002 mL in 1 POUCH2 mlHistorical
68479-202-02684790202021 in 1 CARTONHistorical