Adapalene

Manufacturer
YYBA CORP
Effective date
2025-12-01
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:22:10

Label at a glance#

ProductAdapalene
Active ingredientADAPALENE
Label structure15 sections

Dosage and administration

clean the skin gently and pat dry before applying the product cover the entire affected area with a thin layer. For example, if your acne in on the face, apply the product to the entire face. do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation. Children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Adapalene USP 0.1% (retinoid)*

*read consumer information leaflet

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on damaged skin (cuts, abrasions eczema, sunburn)

if you are allergic to adapalene or any of the ingredients in this product

Pregnancy/Breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a doctor before use.

When using this product

OTC - WHEN USING SECTION

limit sun exposure, including light from tanning beds, and use sunscreen when going outdoors.

do not wax to remove hair in areas where the product has been applied

during the early weeks of use, your acne may appear to worsen before it improves (this is normal); continue using as directed, unless you get irritation that become severe

irritation (redness, itching, dryness, burning) is more likely to occur:

  • in the first few weeks of use
  • if using more than one topical acne medication at a time
  • but irritation usually lessens with continued use of this product

it may take up to 3 months of once daily use to see result

avoid product contact eyes, lips, and month. If contact occurs immediately flush the area with water.

wash hands after use

Stop use and ask a doctor if

OTC - STOP USE SECTION

you become pregnant, or planning to become pregnant while using this product

you have symptoms of an allergic reaction (such as itching, rash, hives, swelling of the lips, eyelids, and shortness of breath)

irritation become severe

you see no improvement after 3 months of once daily use

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

clean the skin gently and pat dry before applying the product
cover the entire affected area with a thin layer. For example, if your acne in on the face, apply the product to the entire face.
do not use more than one time a day. Applying more than directed will not provide faster or better results, but may worsen skin irritation.

Children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

store at rooms temperature 68º to 77ºF

protect from freezing

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer typeC, edetate disodium, methylparabem, poloxamer 182, propylene glycol, purified water. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

†Compare to the active ingredient in Differin® Gel

Adapalene Gel USP 0.1%

Acne Treatment

  • Previously available only by prescription
  • Once daily topical retinoid*
  • Oil free
  • Fragrance free
  • Dermatologist developed and tested

NET WT OZ (g)

*READ CONSUMER INFORMATION LEAFLET BEFORE USE.

*Read cartonand enclosed consumer information leaflet before using this product. Keep this carton and consumer information leaflet. They contain important information.

†This product is not manufactured or distributed by Galderma Laboratories, L.P. distributor of Differin® Gel.

DISTRIBUTED BY

Wellspring Meds

Airmont, NY 10952

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
307731adapalene 0.1 % Topical GelPSN1
307731adapalene 0.001 MG/MG Topical GelSCD1
307731adapalene 0.1 % Topical GelSY1

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ADAPALENE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130373581000203GTIN-13: 0373581000203
EAN-13: 0373581000203
GTIN-12: 373581000203
UPC-A: 373581000203
GTIN storage (14 digits): 00373581000203
Screenshot 2025-12-11 114400.jpg

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
73581-215-45Adapalene45 g in 1 TUBEGEL451
73581-215-45Adapalene1 in 1 CARTONGEL11

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73581-21573581-215-45

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-0284e616aacf4f…
2026-08-18 06:07:402026-07A090962-001ADAPALENE0.1%GEL / TOPICAL2010-06-02caaa826d4ba7…
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…

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…

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
AdapaleneADAPALENEYYBA CORP44eb8cf6-d8ed-0e08-e063-6394a90ac8ef2025-12-01WarningsExact identifier
ndc (package): 73581-215-45
ndc (product): 73581-215
ndc11 (package): 73581021545
spl id: 44eb8cf6-d8ee-0e08-e063-6394a90ac8ef
spl set id: 44eb8cf6-d8ed-0e08-e063-6394a90ac8ef

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.