Differin

Product NDC
0299-5912
11-digit product format
002995912
Labeler code
0299
Product ID
0299-5912_676f04a0-99a9-484f-9d40-62f710ea7fe1
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
adapalene
Dosage form
LOTION
Route
TOPICAL
Labeler
Galderma Laboratories, L.P.
Application
NDA022502
Marketing category
NDA
Marketing start
2010-03-31
Marketing end
0000-00-00
Substance
ADAPALENE
Active strength
0 g/100mL
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 · 3 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0299-5912DDiscontinued by firm2026-08-11
excluded packagepackage0299-59120299-5912-01DDiscontinued by firm2026-08-11
excluded packagepackage0299-59120299-5912-02DDiscontinued by firm2026-08-11

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
N022502-001DIFFERINADAPALENE0.1%LOTION / TOPICALRLD2010-03-17

Orange Book patents#

Current patent rows page 1 of 1 · 3 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N022502-00184355022026-09-15U-1078Drug product2013-05-22
N022502-00187093922026-09-15U-1078Drug product2014-05-16
N022502-00179984672028-05-31U-1078Drug product2011-08-19

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 UTC2026-02N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-17011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-1731067a03dcf5…
2025-08-23 18:47 UTC2025-08N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-176a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-17fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-17b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-1703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-172680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-175bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-17d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-17d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-1779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-17301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022502-001DIFFERIN0.1%LOTION / TOPICALRLD2010-03-171e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-178072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-175c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-175d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-174b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-1774a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-1787673890dc5c…
2021-03-12 10:30 UTC2021-03N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-175aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-178869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-173f01610625f2…
2019-09-15 20:21 UTC2019-09N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17b00525d2431f…
2019-07-19 19:46 UTC2019-07N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-176a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-171c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-179b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-173f0d92c62455…
2023-05-13 08:27 UTC2023-05N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17053a50430f4f…
2023-01-26 05:58 UTC2023-01N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-173bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-173a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N022502-001DIFFERIN0.1%LOTION / TOPICALRLD, RS2010-03-17cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 4 · 123 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N022502-00184355022026-09-15U-1078Drug product2013-05-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022502-00187093922026-09-15U-1078Drug product2014-05-16011fe1cb6892…
2026-02-19 14:30 UTC2026-02N022502-00179984672028-05-31U-1078Drug product2011-08-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022502-00184355022026-09-15U-1078Drug product2013-05-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022502-00187093922026-09-15U-1078Drug product2014-05-1631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022502-00179984672028-05-31U-1078Drug product2011-08-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N022502-00184355022026-09-15U-1078Drug product2013-05-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022502-00187093922026-09-15U-1078Drug product2014-05-166a471c1ec25d…
2025-08-23 18:47 UTC2025-08N022502-00179984672028-05-31U-1078Drug product2011-08-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022502-00184355022026-09-15U-1078Drug product2013-05-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022502-00187093922026-09-15U-1078Drug product2014-05-16fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022502-00179984672028-05-31U-1078Drug product2011-08-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022502-00184355022026-09-15U-1078Drug product2013-05-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022502-00187093922026-09-15U-1078Drug product2014-05-16b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022502-00179984672028-05-31U-1078Drug product2011-08-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022502-00184355022026-09-15U-1078Drug product2013-05-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022502-00187093922026-09-15U-1078Drug product2014-05-1603ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022502-00179984672028-05-31U-1078Drug product2011-08-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022502-00184355022026-09-15U-1078Drug product2013-05-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022502-00187093922026-09-15U-1078Drug product2014-05-162680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022502-00179984672028-05-31U-1078Drug product2011-08-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022502-00184355022026-09-15U-1078Drug product2013-05-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022502-00187093922026-09-15U-1078Drug product2014-05-165bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022502-00179984672028-05-31U-1078Drug product2011-08-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022502-00184355022026-09-15U-1078Drug product2013-05-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022502-00187093922026-09-15U-1078Drug product2014-05-16d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022502-00179984672028-05-31U-1078Drug product2011-08-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022502-00184355022026-09-15U-1078Drug product2013-05-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N022502-00187093922026-09-15U-1078Drug product2014-05-16d06236e962d9…
2024-10-29 15:01 UTC2024-10N022502-00179984672028-05-31U-1078Drug product2011-08-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022502-00184355022026-09-15U-1078Drug product2013-05-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022502-00187093922026-09-15U-1078Drug product2014-05-1679d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022502-00179984672028-05-31U-1078Drug product2011-08-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022502-00184355022026-09-15U-1078Drug product2013-05-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022502-00187093922026-09-15U-1078Drug product2014-05-16301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022502-00179984672028-05-31U-1078Drug product2011-08-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022502-00184355022026-09-15U-1078Drug product2013-05-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022502-00187093922026-09-15U-1078Drug product2014-05-161e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022502-00179984672028-05-31U-1078Drug product2011-08-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022502-00184355022026-09-15U-1078Drug product2013-05-228072bd15b7f6…

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
91d0a1ed-5d14-5017-c7aa-3602ee038695Product name320210111
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
5c3dfd42-8936-4261-a420-cfcbbf3030aaProduct name220161206
08f39758-2d46-8afe-73ca-39fe69052a2bProduct name120140508
8ae7bcde-1dd2-b073-852b-f464987f7427Product name120140508

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5912-02ML - Milliliter0299-59122f2d7727-e3b8-4ee4-82ee-45fa779ca38612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
AdapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Carbomer Homopolymer Type AINACTIVE INGREDIENTF68VH75CJCDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Medium-chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Poloxamer 124INACTIVE INGREDIENT1S66E28KXADIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
POLYETHYLENE GLYCOL 1500INACTIVE INGREDIENT1212Z7S33ADIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
POLYETHYLENE GLYCOL 300INACTIVE INGREDIENT5655G9Y8AQDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]8
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
AdapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Carbomer Homopolymer Type AINACTIVE INGREDIENTF68VH75CJCDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Medium-chain TriglyceridesINACTIVE INGREDIENTC9H2L21V7UDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Poloxamer 124INACTIVE INGREDIENT1S66E28KXADIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Propylene GlycolINACTIVE INGREDIENT6DC9Q167V3DIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Sodium HydroxideINACTIVE INGREDIENT55X04QC32IDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
Stearyl AlcoholINACTIVE INGREDIENT2KR89I4H1YDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) LOTION [PHYSICIANS TOTAL CARE, INC.]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5912DIFFERIN (ADAPALENE) LOTION [GALDERMA LABORATORIES, L.P.]14Legacy NDC20241027_78b3c1f9-0fc2-4075-6cf0-454a492e6ae3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
905385adapalene 0.1 % Topical LotionPSN5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387Differin 0.1 % Topical LotionPSN5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387adapalene 1 MG/ML Topical Lotion [Differin]SBD5c7981be-509d-4dc1-a6b6-78e047942cdd2
905385adapalene 1 MG/ML Topical LotionSCD5c7981be-509d-4dc1-a6b6-78e047942cdd2
905385adapalene 0.1 % Topical LotionSY5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387Differin 0.1 % Topical LotionSY5c7981be-509d-4dc1-a6b6-78e047942cdd2
905387Differin 1 MG/ML Topical LotionSY5c7981be-509d-4dc1-a6b6-78e047942cdd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5912-010029959120115 mL in 1 BOTTLE (0299-5912-01) 15 ml2010-04-270000-00-00NoNoCurrent
0299-5912-02002995912021 BOTTLE, PUMP in 1 CARTON (0299-5912-02) > 59 mL in 1 BOTTLE, PUMP2010-04-270000-00-00NoNoCurrent