Neutrogena Adapalene 0.1% Acne Treatment

Product NDC
69968-0826
11-digit product format
699680826
Labeler code
69968
Product ID
69968-0826_21bf71d1-8aea-5bec-e063-6294a90aed2c
Type
HUMAN OTC DRUG
Nonproprietary name
Adapalene
Dosage form
GEL
Route
TOPICAL
Labeler
Kenvue Brands LLC
Application
ANDA090962
Marketing category
ANDA
Marketing start
2023-12-04
Substance
ADAPALENE
Active strength
1 mg/g
Pharmacologic classes
Retinoid [EPC], Retinoids [CS]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

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
A090962-001ADAPALENEADAPALENE0.1%GEL / TOPICAL2010-06-02

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 UTC2026-02A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-0231067a03dcf5…
2025-08-23 18:47 UTC2025-08A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-026a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-0203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-022680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-025bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-0279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-021e350fbaab3a…
2024-05-31 18:47 UTC2024-05A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-028072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-025c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-025d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-024b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A090962-001ADAPALENE0.1%GEL / TOPICALAB2010-06-0274a2ff9319b5…
2022-03-09 01:35 UTC2022-03A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-0287673890dc5c…
2021-03-12 10:30 UTC2021-03A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-025aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-028869cabd3fbd…
2020-11-12 02:37 UTC2020-11A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02c0c555d07b60…
2019-12-14 00:12 UTC2019-12A090962-001ADAPALENE0.1%GEL / TOPICALAB2010-06-023f01610625f2…
2019-09-15 20:21 UTC2019-09A090962-001ADAPALENE0.1%GEL / TOPICALAB2010-06-02b00525d2431f…
2019-07-19 19:46 UTC2019-07A090962-001ADAPALENE0.1%GEL / TOPICALAB2010-06-02ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-026a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-021c564ffb4f44…
2023-12-20 04:57 UTC2023-12A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-029b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-023f0d92c62455…
2023-05-13 08:27 UTC2023-05A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02053a50430f4f…
2023-01-26 05:58 UTC2023-01A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-023bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-023a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A090962-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A090962-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A090962-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A090962-001AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Neutrogena Adapalene 0.1% Acne Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
ADAPALENE1 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1L4806J2QFInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
307731Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0682cb55-6ae3-437f-e063-6294a90ac510Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
69968-0826-1Neutrogena Adapalene 0.1% Acne Treatment1 in 1 CARTONGEL12
69968-0826-1Neutrogena Adapalene 0.1% Acne Treatment45 g in 1 TUBEGEL452

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69968-0826NEUTROGENA ADAPALENE 0.1% ACNE TREATMENT (ADAPALENE) GEL [KENVUE BRANDS LLC]2Current NDC, 2 package rows20241115_0682cb55-6ae3-437f-e063-6294a90ac510.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 · 12 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
AdapaleneADAPALENESafeway, Inc.a9816181-d643-4579-8b12-3927120dc6272026-06-18WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne TreatmentADAPALENEKenvue Brands LLC4dfe533e-d3dc-b7ff-e063-6394a90ac61b2026-04-08WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENEThe Kroger Co.1238c72c-1c51-46e4-b15c-61093b03608e2026-03-23WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENEP & L Development, LLCe9155950-6c92-4f57-851a-51be6ba9062f2025-12-16WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENEYYBA CORP44eb8cf6-d8ed-0e08-e063-6394a90ac8ef2025-12-01WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENETopco Associates5693e3c9-00e5-4e62-b44a-47be2dc318112025-10-06WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
Neutrogena Evenly Clear Retinoid Adapalene Gel 0.1% Acne TreatmentADAPALENEKenvue Brands LLC3f9b75cf-75aa-9012-e063-6294a90a64692025-10-01WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENEMeijer Distribution Inc.f2c25c70-87b7-482f-b23a-467008761a3e2025-09-09WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENEWalgreens2c1cdc03-087d-43b0-b0b3-503a35398a532025-05-16WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
AdapaleneADAPALENEWalgreens84ab65a4-b343-4ad9-8049-aea1ec0290312025-03-12WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
Neutrogena Adapalene 0.1% Acne TreatmentADAPALENEKenvue Brands LLC0682cb55-6ae3-437f-e063-6294a90ac5102024-11-12WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962
ndc (product): 69968-0826
AdapaleneADAPALENECVS PHARMACY, INCff9a929e-121b-42b4-8e79-f8f46c22a8be2024-02-21WarningsExact identifier
application applno (ANDA): 090962
application number: ANDA090962

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
307731adapalene 0.1 % Topical GelPSN0682cb55-6ae3-437f-e063-6294a90ac5102
307731adapalene 0.001 MG/MG Topical GelSCD0682cb55-6ae3-437f-e063-6294a90ac5102
307731adapalene 0.1 % Topical GelSY0682cb55-6ae3-437f-e063-6294a90ac5102

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69968-0826-1699680826011 TUBE in 1 CARTON (69968-0826-1) / 45 g in 1 TUBE1 tube2023-12-04NoNoCurrent