Proactiv MD Adapalene

Product NDC
11410-956
11-digit product format
114100956
Labeler code
11410
Product ID
11410-956_f1364b67-9750-4d0d-bc59-8b100c462376
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Alchemee, LLC
Application
NDA020380
Marketing category
NDA AUTHORIZED GENERIC
Marketing start
2017-03-27
Marketing end
0000-00-00
Substance
ADAPALENE
Active strength
0 g/100g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2023-12-31
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct11410-956DDiscontinued by firm2026-08-11
excluded packagepackage11410-95611410-956-17DDiscontinued by firm2026-08-11
excluded packagepackage11410-95611410-956-38DDiscontinued by firm2026-08-11
excluded packagepackage11410-95611410-956-44DDiscontinued by firm2026-08-11

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 · 36 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 packagepackage11410-956-17DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11410-956-38DDiscontinued by firmd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage11410-956-44DDiscontinued 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 packagepackage11410-956-17DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11410-956-38DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage11410-956-44DDiscontinued by firmf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11410-956-17IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11410-956-38IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage11410-956-44IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11410-956-17IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11410-956-38IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage11410-956-44IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11410-956-17IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11410-956-38IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage11410-956-44IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11410-956-17IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11410-956-38IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage11410-956-44IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11410-956-38UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11410-956-17UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage11410-956-44UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11410-956-38UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11410-956-17UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage11410-956-44UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11410-956-38UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11410-956-17UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage11410-956-44UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N020380-002DIFFERINADAPALENE0.1%GEL / TOPICALRLD, RS2016-07-08

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 41 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N020380-002DIFFERIN0.1%GEL / TOPICALRLD, RS2016-07-08cb3db0bc1861…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N020380-002RTO2019-07-0874a2ff9319b5…
2019-12-14 00:12 UTC2019-12N020380-002RTO2019-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09N020380-002RTO2019-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N020380-002RTO2019-07-08ea99ee380514…

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11410-956PROACTIV MD ADAPALENE ACNE TREATMENT (ADAPALENE) GEL [ALCHEMEE, LLC]4Legacy NDC20221201_ab771c7e-ed01-442c-be0e-d368db6e4100.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 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DifferinADAPALENEGalderma Laboratories, L.P.0739d631-171b-42a8-bd55-0022b8df2d8a2022-12-07WarningsExact identifier
application applno (NDA): 020380
application number: NDA020380

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
11410-956-17114100956171 TUBE in 1 BOX (11410-956-17) > 45 g in 1 TUBE1 tube2017-03-270000-00-00NoNoCurrent
11410-956-38114100956381 TUBE in 1 BLISTER PACK (11410-956-38) > 2 g in 1 TUBE1 tube2017-08-090000-00-00NoNoCurrent
11410-956-44114100956441 TUBE in 1 BOX (11410-956-44) > 15 g in 1 TUBE1 tube2017-03-270000-00-00NoNoCurrent