Differin

Product NDC
0299-5915
11-digit product format
002995915
Labeler code
0299
Product ID
0299-5915_e308ee59-596a-4f36-b4b7-85012575041d
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Adapalene
Dosage form
CREAM
Route
TOPICAL
Labeler
GALDERMA LABORATORIES, L.P
Application
NDA020748
Marketing category
NDA
Marketing start
2009-11-24
Marketing end
2027-05-31
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Current FDA listing
Yes

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 productproduct0299-5915DDiscontinued by firm2026-08-17
excluded packagepackage0299-59150299-5915-45DDiscontinued by firm2026-08-17

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

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
N020748-001DIFFERINADAPALENE0.1%CREAM / TOPICALABRLD, RS2000-05-26

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-productTE code
N020748-001AB

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 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-2687673890dc5c…
2021-03-12 10:30 UTC2021-03N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-263f01610625f2…
2019-09-15 20:21 UTC2019-09N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26b00525d2431f…
2019-07-19 19:46 UTC2019-07N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-263f0d92c62455…
2023-05-13 08:27 UTC2023-05N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26053a50430f4f…
2023-01-26 05:58 UTC2023-01N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020748-001DIFFERIN0.1%CREAM / TOPICALABRLD, RS2000-05-26e64feba35796…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 42 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N020748-001AB1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N020748-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N020748-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08N020748-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N020748-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N020748-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N020748-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N020748-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N020748-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N020748-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N020748-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N020748-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N020748-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N020748-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N020748-001AB18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N020748-001AB15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N020748-001AB15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N020748-001AB14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N020748-001AB174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N020748-001AB1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N020748-001AB1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N020748-001AB187673890dc5c…
2021-03-12 10:30 UTC2021-03N020748-001AB15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N020748-001AB18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N020748-001AB1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N020748-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09N020748-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07N020748-001AB1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N020748-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N020748-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N020748-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N020748-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N020748-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N020748-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N020748-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05N020748-001AB1053a50430f4f…
2023-01-26 05:58 UTC2023-01N020748-001AB13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N020748-001AB13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N020748-001AB1f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N020748-001AB1e64feba35796…

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0299-5915-45Differin45 g in 1 TUBECREAM458
0299-5915-45Differin1 in 1 CARTONCREAM18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0299-5915-45GM - Gram0299-5915aceb62d6-9220-449c-92bb-c65240edd2a612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
AdapaleneACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
AdapaleneACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
Edetate DisodiumINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
GlycerinINACTIVE INGREDIENTPDC6A3C0OXDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
PhenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
PropylparabenINACTIVE INGREDIENTZ8IX2SC1OHDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
SqualaneINACTIVE INGREDIENTGW89575KF9DIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
TrolamineINACTIVE INGREDIENT9O3K93S3TKDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
WaterINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]3
ADAPALENEACTIVE INGREDIENT1L4806J2QFDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
ADAPALENEACTIVE MOIETY1L4806J2QFDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86KDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9TDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
SQUALANEINACTIVE INGREDIENTGW89575KF9DIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TKDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RDIFFERIN (ADAPALENE) CREAM [PHYSICIANS TOTAL CARE, INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0299-5915DIFFERIN (ADAPALENE) CREAM [GALDERMA LABORATORIES, L.P]7Current NDC, Legacy NDC, 2 package rows20221209_ab4b2120-57fc-6c61-b239-37c21789c065.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
AdapaleneADAPALENEPadagis Israel Pharmaceuticals Ltd94cf9af1-afab-4064-a2ca-619b542182622023-07-25Adverse reactionsExact identifier
application applno (NDA): 020748
application number: NDA020748

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313852adapalene 0.1 % Topical CreamPSNab4b2120-57fc-6c61-b239-37c21789c0658
284420Differin 0.1 % Topical CreamPSNab4b2120-57fc-6c61-b239-37c21789c0658
284420adapalene 1 MG/ML Topical Cream [Differin]SBDab4b2120-57fc-6c61-b239-37c21789c0658
313852adapalene 1 MG/ML Topical CreamSCDab4b2120-57fc-6c61-b239-37c21789c0658
313852adapalene 0.1 % Topical CreamSYab4b2120-57fc-6c61-b239-37c21789c0658
284420Differin 0.1 % Topical CreamSYab4b2120-57fc-6c61-b239-37c21789c0658
284420Differin 1 MG/ML Topical CreamSYab4b2120-57fc-6c61-b239-37c21789c0658

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0299-5915-45002995915451 TUBE in 1 CARTON (0299-5915-45) / 45 g in 1 TUBE1 tube2009-11-242027-05-31NoNoCurrent