FDA.reportPublic FDA data

Benzoyl Acne Wash -2.5% Benzoyl Peroxide

Product NDC
70367-009
11-digit product format
703670009
Labeler code
70367
Product ID
70367-009_9cd5703c-a84e-955b-e053-2995a90a87af
Type
HUMAN OTC DRUG
Nonproprietary name
Benzoyl Peroxide
Dosage form
SOAP
Route
TOPICAL
Labeler
Only Yourx, Inc.
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2014-08-26
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
3 g/100mL
NDC exclude flag
No
Listing certified through
2021-12-31
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
70367-009-042022-07-29C16284748780-1e4f33bdf-a017-d8a0-e053-dadaa90a6e4e77468c7b-1906-c4fa-e053-2991aa0a8f06
70367-009-082022-07-29C16284748780-1e4f33bdf-a017-d8a0-e053-dadaa90a6e4e77468c7b-1906-c4fa-e053-2991aa0a8f06
70367-009-752022-07-29C16284748780-1e4f33bdf-a017-d8a0-e053-dadaa90a6e4e77468c7b-1906-c4fa-e053-2991aa0a8f06

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70367-009-04Benzoyl Acne Wash -2.5% Benzoyl Peroxide120 mL in 1 TUBESOAP1202
70367-009-08Benzoyl Acne Wash -2.5% Benzoyl Peroxide240 mL in 1 TUBESOAP2402
70367-009-75Benzoyl Acne Wash -2.5% Benzoyl Peroxide22.2 mL in 1 TUBESOAP22.22

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70367-009BENZOYL ACNE WASH -2.5% BENZOYL PEROXIDE (BENZOYL PEROXIDE) SOAP [ONLY YOURX, INC.]2Legacy NDC, 3 package rows20200124_77468c7b-1906-c4fa-e053-2991aa0a8f06.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
845836benzoyl peroxide 2.5 % Medicated Liquid SoapPSN77468c7b-1906-c4fa-e053-2991aa0a8f062
845836benzoyl peroxide 25 MG/ML Medicated Liquid SoapSCD77468c7b-1906-c4fa-e053-2991aa0a8f062
845836benzoyl peroxide 2.5 % Medicated Liquid SoapSY77468c7b-1906-c4fa-e053-2991aa0a8f062

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
70367-009-0470367000904120 mL in 1 TUBE (70367-009-04) 120 ml2014-08-260000-00-00NoNoCurrent
70367-009-0870367000908240 mL in 1 TUBE (70367-009-08) 240 ml2014-08-260000-00-00NoNoCurrent
70367-009-757036700097522.2 mL in 1 TUBE (70367-009-75) 22.2 ml2014-08-260000-00-00NoNoCurrent