FDA.reportPublic FDA data

adapalene and benzoyl peroxide swab

Product NDC
69150-001
Requested package NDC
69150-001-14
11-digit product format
691500001
Labeler code
69150
Product ID
69150-001_b7754432-7442-4552-9823-326e46c6f8eb
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene and benzoyl peroxide
Dosage form
GEL
Route
TOPICAL
Labeler
Biomes Pharmaceuticals
Marketing category
UNAPPROVED DRUG OTHER
Marketing start
2020-12-01
Marketing end
0000-00-00
Substance
ADAPALENE; BENZOYL PEROXIDE
Active strength
1 mg/g; mg/g
Pharmacologic classes
Retinoid [EPC],Retinoids [CS]
NDC exclude flag
No
Listing certified through
2021-12-31
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 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage69150-00169150-001-14IInactivated by FDA2026-08-03

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 · 18 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…
2024-05-28 21:12 UTC · source 2024-05-288af77b9d5b6f…d9bbb34c5368…
2024-05-15 03:39 UTC · source 2024-05-14834df4deac94…adcc014656a3…
2024-03-11 06:39 UTC · source 2024-03-081332a3947898…d4bfe170f9cd…
2022-08-30 03:57 UTC · source 2022-08-29fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-0886f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01bd6a592717d7…303034d00443…

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
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69150-001-142022-01-28C16284748780-1d6a99b39-b53e-a426-e053-dadaa90af4c2These highlights do not include all the information needed to use Adapalene and Benzoyl Peroxide Gel safely and effectively. See full prescribing information for Adapalene and Benzoyl Peroxide Swabs.Adapalene and Benzoyl Peroxide Gel 0.1% / 2.5% For topical use Initial U.S. Approval:

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69150-001-00adapalene and benzoyl peroxide swab1.2 g in 1 POUCHGEL1.21
69150-001-14adapalene and benzoyl peroxide swab14 in 1 CARTONGEL141

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69150-001-14EA - Each69150-001878de1a9-6c84-45e3-9d31-f0481ec05d2012024-04-05

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69150-001ADAPALENE AND BENZOYL PEROXIDE SWAB (ADAPALENE AND BENZOYL PEROXIDE) GEL [BIOMES PHARMACEUTICALS]1Legacy NDC, 2 package rows20201224_5510c3a7-08c4-42bd-b610-6b9fc143c1ee.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2471107adapalene 0.1 % / benzoyl peroxide 2.5 % SwabPSN5510c3a7-08c4-42bd-b610-6b9fc143c1ee1
2471107adapalene 1 MG/ML / benzoyl peroxide 25 MG/ML Medicated PadSCD5510c3a7-08c4-42bd-b610-6b9fc143c1ee1
2471107adapalene 0.1 % / benzoyl peroxide 2.5 % SwabSY5510c3a7-08c4-42bd-b610-6b9fc143c1ee1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69150-001-146915000011414 POUCH in 1 CARTON (69150-001-14) > 1.2 g in 1 POUCH (69150-001-00) 14 pouch2020-12-010000-00-00NoNoCurrent