Acne Free SEVERE ACNE 24 HR Acne Clearing System

Product NDC
80861-010
11-digit product format
808610010
Labeler code
80861
Product ID
80861-010_3aaf0199-8fc8-f4d1-e063-6294a90a87bd
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
KIT
Labeler
AcneFree, LLC
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-01
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Acne Free SEVERE ACNE 24 HR Acne Clearing System
Listing expiration
2026-12-31

Harmonized Identifiers#

Field, Values table
FieldValues
Rxcui106310, 845836, 2048989

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80861-004-01Acne Free SEVERE ACNE 24 HR Acne Clearing System118 mL in 1 BOTTLEGEL118 mL25 mg in 1mL6
80861-010-01Acne Free SEVERE ACNE 24 HR Acne Clearing System1 in 1 KITKIT16
80861-011-01Acne Free SEVERE ACNE 24 HR Acne Clearing System59 mL in 1 BOTTLELOTION59 mL100 mg in 1mL6

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80861-010ACNE FREE SEVERE ACNE 24 HR ACNE CLEARING SYSTEM (BENZOYL PEROXIDE) KIT [ACNEFREE, LLC]5Current NDC, Legacy NDC, 3 package rows20240620_c939681e-ea93-31ce-e053-2a95a90a8c70.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2048989{1 (59 ML) (benzoyl peroxide 100 MG/ML Topical Lotion) / 1 (118 ML) (benzoyl peroxide 25 MG/ML Medicated Liquid Soap) } PackGPCKc939681e-ea93-31ce-e053-2a95a90a8c706
106310benzoyl peroxide 10 % Topical LotionPSNc939681e-ea93-31ce-e053-2a95a90a8c706
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSNc939681e-ea93-31ce-e053-2a95a90a8c706
2048989benzoyl peroxide 2.5 % Medicated Liquid Soap (4 OZ) / benzoyl peroxide 10 % Topical Lotion (2 OZ) PackPSNc939681e-ea93-31ce-e053-2a95a90a8c706
106310benzoyl peroxide 100 MG/ML Topical LotionSCDc939681e-ea93-31ce-e053-2a95a90a8c706
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCDc939681e-ea93-31ce-e053-2a95a90a8c706
106310benzoyl peroxide 10 % Topical LotionSYc939681e-ea93-31ce-e053-2a95a90a8c706
845836benzoyl peroxide 2.5 % Medicated Liquid SoapSYc939681e-ea93-31ce-e053-2a95a90a8c706

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80861-004-0180861000401118 mL in 1 BOTTLE118 mlHistorical
80861-010-01808610010011 KIT in 1 KIT (80861-010-01) * 118 mL in 1 BOTTLE (80861-004-01) * 59 mL in 1 BOTTLE (80861-011-01) 1 kit2017-12-010000-00-00NoNoCurrent
80861-011-018086100110159 mL in 1 BOTTLE59 mlHistorical