ACNE MEDICATION 5

Product NDC
0536-0810
11-digit product format
005360810
Labeler code
0536
Product ID
0536-0810_57391419-7fdf-49d8-bac7-0ce353f0a835
Type
HUMAN OTC DRUG
Nonproprietary name
BENZOYL PEROXIDE
Dosage form
LOTION
Route
TOPICAL
Labeler
Rugby Laboratories
Application
part333D
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2012-10-29
Marketing end
0000-00-00
Substance
BENZOYL PEROXIDE
Active strength
50 mg/1000mL
NDC exclude flag
E
Listing certified through
2017-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0536-0810DDiscontinued by firm2026-08-17
excluded packagepackage0536-08100536-0810-95DDiscontinued by firm2026-08-17

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 26 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductDDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0536-0810-95DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductDDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0536-0810-95DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductDDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0536-0810-95DDiscontinued by firm2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductDDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0536-0810-95DDiscontinued by firma1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductDDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0536-0810-95DDiscontinued by firmcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductDDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0536-0810-95DDiscontinued by firmcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductDDiscontinued by firm302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0536-0810-95DDiscontinued by firm302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductDDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0536-0810-95DDiscontinued by firmed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductDDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0536-0810-95DDiscontinued by firm0efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductDDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0536-0810-95DDiscontinued by firmad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproductDDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0536-0810-95DDiscontinued by firm367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproductDDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0536-0810-95DDiscontinued by firm557ba5c1ecfa…9c80585c8c6e…
2019-12-08 06:16 UTC · source 2019-12-05excluded productproductIInactivated by FDA110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage0536-0810-95IInactivated by FDA110d247fa046…a55b01930146…

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0536-0810-952019-12-08C16284748780-19855d018-e9c6-cd31-e053-dbdaa90ab51aBENZOYL PEROXIDE TOPICAL WASH 5% DRUG FACTS
0536-0810-952019-11-27C16284748780-19855d018-e9c6-cd31-e053-dbdaa90ab51aBENZOYL PEROXIDE TOPICAL WASH 5% DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-0810-95ML - Milliliter0536-081000d9c7f1-2c59-49ac-bf5c-3c6113e53dae12013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GMACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GMACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2
CARBOMER COPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED)INACTIVE INGREDIENT71DD5V995LACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2
DIISOPROPANOLAMINEINACTIVE INGREDIENT0W44HYL8T5ACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2
STEARETH-30INACTIVE INGREDIENT5776GCL1DGACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2
WATERINACTIVE INGREDIENT059QF0KO0RACNE MEDICATION 5 (BENZOYL PEROXIDE) LOTION [RUGBY LABORATORIES]2