FDA.reportPublic FDA data

Benzoyl Peroxide Acne

Product NDC
73318-7006
11-digit product format
733187006
Labeler code
73318
Product ID
73318-7006_4736db04-1189-d338-e063-6394a90a9052
Type
HUMAN OTC DRUG
Nonproprietary name
Acne Lotion
Dosage form
LOTION
Route
TOPICAL
Labeler
Skin PS Brands
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
BENZOYL PEROXIDE
Active strength
25 mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product
Yes
Brand name base
Benzoyl Peroxide Acne
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOYL PEROXIDE25 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
W9WZN9A0GMInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
200009Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0792f466-f19c-acf0-e063-6294a90a6f91Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
77dc03a4-fbfc-e6a3-fe95-285bbae40d75Product name220250814
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
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73318-7006-1Benzoyl Peroxide Acne44 g in 1 BOTTLE, PUMPLOTION443
73318-7006-1Benzoyl Peroxide Acne1 in 1 CARTONLOTION13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73318-7006BENZOYL PEROXIDE ACNE (ACNE LOTION) LOTION [SKIN PS BRANDS]2Current NDC, 2 package rows20241228_0792f466-f19c-acf0-e063-6294a90a6f91.zip

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 23 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Clear Smart Clear Complexion TonerSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a517dfe5-e4a0-5f2d-e053-2a95a90a2ec12025-10-21WarningsExact identifier
application number: M006
Clear Smart Clarifying Cleansing FoamSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.a564d38c-d674-29db-e053-2995a90ab3b42025-10-21WarningsExact identifier
application number: M006
Clear Smart Clear Pore HydratorSALICYLIC ACIDDistribuidora Comercial Jafra, S.A. de C.V.dd6e63a6-91d8-41de-9cb7-f88b68c528d02025-10-21WarningsExact identifier
application number: M006
Acne Fighting Putty PrimerSALICYLIC ACIDe.l.f. Cosmetics, Inc657fd325-dd3f-4246-8486-fb5405a52c612025-10-21WarningsExact identifier
application number: M006
Acne Fighting Spot GelSALICYLIC ACIDe.l.f. Cosmetics, Inceca08910-58b9-4ce6-8e97-4b97c30784f52025-10-21WarningsExact identifier
application number: M006
Blemish Control Basics KitSALICYLIC ACIDe.l.f. Cosmetics, Inc1caf8dbb-18c2-48e9-a8b2-f4f53a4a32d22025-10-21WarningsExact identifier
application number: M006
Oil-Free Foaming Acne WashSALICYLIC ACIDRejoice Internationalcfc2efe1-3eb4-4262-ba68-d1201770297c2025-10-20WarningsExact identifier
application number: M006
Dr.Mellaxeen SKIN SAVER DAILY ACNE ESSENTIALS KitSALICYLIC ACIDLongway Lab Inc.41931e38-0e3c-e322-e063-6394a90af4012025-10-20WarningsExact identifier
application number: M006
Acne WashSALICYLIC ACIDTarget Corporation1c81d366-3bf9-c33e-e063-6294a90a3ca22025-10-18WarningsExact identifier
application number: M006
Dr Mellaxeen SKIN SAVER ACNE RELIEF StickSALICYLIC ACIDLongway Technology(Guangzhou) Co., Ltd.41672e2e-2b70-e879-e063-6294a90a81b02025-10-17WarningsExact identifier
application number: M006
SOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMSOME BY MI AHA BHA PHA 30 DAYS MIRACLE ACNE CLEAR FOAMPERENNEBELL Co., Ltd.0897ccca-fa18-873f-e063-6394a90a59ab2025-10-16WarningsExact identifier
application number: M006
Acne Calming Water CreamSALICYLIC ACIDe.l.f. Cosmetics, Inc.01b70e53-9e24-4950-bbe9-c58905b6e68d2025-10-15WarningsExact identifier
application number: M006
Acne Clarifying CleanserSALICYLIC ACIDe.l.f. Cosmetics, Inc.0e9be1e3-7fa9-4d70-9c89-cf7501d2380b2025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology9e057f84-0b46-4ffc-a3bb-5bafc8f6baa52025-10-15WarningsExact identifier
application number: M006
Acne Body WashSALICYLIC ACIDCurology1c2d71c5-2560-462f-adec-14bc38550ba42025-10-15WarningsExact identifier
application number: M006
Stage Fight Acne MaskSULFUR, RESORCINOLCosmetic Enterprises Ltd209e321e-ed20-9c67-e063-6394a90a54102025-10-14WarningsExact identifier
application number: M006
YOUR ANTI-ACNE SERUMSALICYLID ACIDSkin Ai, LLC410d1968-6931-7a48-e063-6294a90abb622025-10-13WarningsExact identifier
application number: M006
GENTLE ACNE SERUMSALICYLIC ACIDDrmtlgy, LLCa8e41339-3f3b-44ad-9b2f-1962d5f66f3d2025-10-10WarningsExact identifier
application number: M006
30 day Acne Treatment KitSALICYLIC ACID, BENZOYL PEROXIDECosmetic Enterprises Ltd039ac054-3eb2-5beb-e063-6394a90a561a2025-10-10WarningsExact identifier
application number: M006
Breakout Control BioelementsBENZOYL PEROXIDECosmetic Enterprises Ltd94462332-2169-4ea1-86b3-25ab9646c6e52025-10-10WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200009benzoyl peroxide 2.5 % Topical LotionPSN0792f466-f19c-acf0-e063-6294a90a6f913
200009benzoyl peroxide 25 MG/ML Topical LotionSCD0792f466-f19c-acf0-e063-6294a90a6f913
200009benzoyl peroxide 2.5 % Topical LotionSY0792f466-f19c-acf0-e063-6294a90a6f913

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startSampleExclude flagStatus
73318-7006-1733187006011 BOTTLE, PUMP in 1 CARTON (73318-7006-1) / 44 g in 1 BOTTLE, PUMP2023-07-01NoNoCurrent