Indications and uses
Adapalene Gel is indicated for the topical treatment of acne vulgaris.
ADAPALENE GEL, 0.1%
- Manufacturer
- Physicians Total Care, Inc.
- Effective date
- 2010-06-02
- Label type
- HUMAN PRESCRIPTION DRUG LABEL
- Version
- 1
- Source
- full-release
- Hydrated at
- 2026-05-31 20:09:27
Label at a glance#
ProductAdapalene
Active ingredientADAPALENE
Label structure11 sections
Dosage and administration
Adapalene Gel should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes. During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic...
Label contents#
Full prescribing information#
DESCRIPTION
Adapalene Gel, containing adapalene, is used for the topical treatment of acne vulgaris. Each gram of Adapalene Gel contains adapalene 0.1% (1 mg) in a vehicle consisting of carbomer homopolymer type C, disodium edetate, methylparaben, poloxamer 182, propylene glycol, purified water and sodium hydroxide. May contain hydrochloric acid to adjust pH.
The chemical name of adapalene is 6-[3-(1-adamantyl)-4-methoxyphenyl]-2-naphthoic acid. Adapalene is a white to off-white powder which is soluble in tetrahydrofuran, sparingly soluble in ethanol, and practically insoluble in water. Adapalene is represented by the following structural formula:
CLINICAL PHARMACOLOGY
Adapalene is a chemically stable, retinoid-like compound. Biochemical and pharmacological profile studies have demonstrated that adapalene is a modulator of cellular differentiation, keratinization, and inflammatory processes all of which represent important features in the pathology of acne vulgaris.
Mechanistically, adapalene binds to specific retinoic acid nuclear receptors but does not bind to the cytosolic receptor protein. Although the exact mode of action of adapalene is unknown, it is suggested that topical adapalene may normalize the differentiation of follicular epithelial cells resulting in decreased microcomedone formation.
Pharmacokinetics
Absorption of adapalene through human skin is low. Only trace amounts (<0.25 ng/mL) of parent substance have been found in the plasma of acne patients following chronic topical application of adapalene in controlled clinical trials. Excretion appears to be primarily by the biliary route.
INDICATIONS AND USAGE
Adapalene Gel is indicated for the topical treatment of acne vulgaris.
CONTRAINDICATIONS
Adapalene gel should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle gel.
WARNINGS
Use of adapalene gel should be discontinued if hypersensitivity to any of the ingredients is noted. Patients with sunburn should be advised not to use the product until fully recovered.
PRECAUTIONS
General
If a reaction suggesting sensitivity or chemical irritation occurs, use of the medication should be discontinued. Exposure to sunlight, including sunlamps, should be minimized during the use of adapalene. Patients who normally experience high levels of sun exposure, and those with inherent sensitivity to sun, should be warned to exercise caution. Use of sunscreen products and protective clothing over treated areas is recommended when exposure cannot be avoided. Weather extremes, such as wind or cold, also may be irritating to patients under treatment with adapalene. Avoid contact with the eyes, lips, angles of the nose, and mucous membranes. The product should not be applied to cuts, abrasions, eczematous skin, or sunburned skin.
Certain cutaneous signs and symptoms such as erythema, dryness, scaling, burning, or pruritus may be experienced during treatment. These are most likely to occur during the first two to four weeks and will usually lessen with continued use of the medication. Depending upon the severity of adverse events, patients should be instructed to reduce the frequency of application or discontinue use.
Drug Interactions
As adapalene gel has the potential to produce local irritation in some patients, concomitant use of other potentially irritating topical products (medicated or abrasive soaps and cleansers, soaps and cosmetics that have a strong drying effect, and products with high concentrations of alcohol, astringents, spices, or lime) should be approached with caution. Particular caution should be exercised in using preparations containing sulfur, resorcinol, or salicylic acid in combination with adapalene gel. If these preparations have been used, it is advisable not to start therapy with adapalene gel until the effects of such preparations in the skin have subsided.
Carcinogenesis, Mutagenesis, Impairment of Fertility
Carcinogenicity studies with adapalene have been conducted in mice at topical doses of 0.3, 0.9, and 2.6 mg/kg/day and in rats at oral doses of 0.15, 0.5, and 1.5 mg/kg/day, approximately 4-75 times the maximal daily human topical dose. In the oral study, positive linear trends were observed in the incidence of follicular cell adenomas and carcinomas in the thyroid glands of female rats, and in the incidence of benign and malignant pheochromocytomas in the adrenal medullas of male rats.
No photocarcinogenicity studies were conducted. Animal studies have shown an increased tumorigenic risk with the use of pharmacologically similar drugs (e.g., retinoids) when exposed to UV irradiation in the laboratory or to sunlight. Although the significance of these studies to human use is not clear, patients should be advised to avoid or minimize exposure to either sunlight or artificial UV irradiation sources.
In a series of in vivo and in vitro studies, adapalene did not exhibit mutagenic or genotoxic activities.
Pregnancy
Teratogenic effects
Pregnancy Category C
No teratogenic effects were seen in rats at oral doses of adapalene 0.15 to 5.0 mg/kg/day, up to 120 times the maximal daily human topical dose. Cutaneous route teratology studies conducted in rats and rabbits at doses of 0.6, 2.0, and 6.0 mg/kg/day, up to 150 times the maximal daily human topical dose exhibited no fetotoxicity and only minimal increases in supernumerary ribs in rats. There are no adequate and well-controlled studies in pregnant women. Adapalene should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Nursing Mothers
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when adapalene gel is administered to a nursing woman.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 12 have not been established.
ADVERSE REACTIONS
Some adverse effects such as erythema, scaling, dryness, pruritus, and burning will occur in 10-40% of patients. Pruritus or burning immediately after application also occurs in approximately 20% of patients. The following additional adverse experiences were reported in approximately 1% or less of patients: skin irritation, burning/stinging, erythema, sunburn, and acne flares. These are most commonly seen during the first month of therapy and decrease in frequency and severity thereafter. All adverse effects with use of adapalene gel during clinical trials were reversible upon discontinuation of therapy.
OVERDOSAGE
Adapalene gel is intended for cutaneous use only. If the medication is applied excessively, no more rapid or better results will be obtained and marked redness, peeling, or discomfort may occur. The acute oral toxicity of adapalene gel in mice and rats is greater than 10 mL/kg. Chronic ingestion of the drug may lead to the same side effects as those associated with excessive oral intake of Vitamin A.
DOSAGE AND ADMINISTRATION
Adapalene Gel should be applied once a day to affected areas after washing in the evening before retiring. A thin film of the gel should be applied, avoiding eyes, lips, and mucous membranes.
During the early weeks of therapy, an apparent exacerbation of acne may occur. This is due to the action of the medication on previously unseen lesions and should not be considered a reason to discontinue therapy. Therapeutic results should be noticed after eight to twelve weeks of treatment.
HOW SUPPLIED
Adapalene Gel, 0.1% is supplied in the following size:
| 45 g | laminate tube | NDC 54868-6132-0 |
Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]
Protect from Freezing.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
Manufactured in Croatia By:
PLIVA Hrvatska d.o.o.
Zagreb, Croatia
Manufactured For:
TEVA PHARMACEUTICALS USA
Sellersville, PA 18960
Iss. 1/2010
Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
PRINCIPAL DISPLAY PANEL
Adapalene Gel 0.1%, 45 Grams, Carton Text
NDC 54868-6132-0
ADAPALENE GEL
0.1%
45 GRAMS
For External Use Only. NOT FOR OPHTHALMIC USE.
Rx only
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| ADAPALENE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| a46239a7-5963-4008-8cbb-6b9000f497eb | Product name | 1 | 20250721 |
| d9d61457-6a5a-41fc-b418-e5479a2904b7 | Product name | 2 | 20230303 |
| 91d0a1ed-5d14-5017-c7aa-3602ee038695 | Product name | 3 | 20210111 |
| 3f45980c-c196-47e5-0e5e-48b7c57327c5 | Product name | 5 | 20200428 |
| 5c3dfd42-8936-4261-a420-cfcbbf3030aa | Product name | 2 | 20161206 |
| 08f39758-2d46-8afe-73ca-39fe69052a2b | Product name | 1 | 20140508 |
| 8ae7bcde-1dd2-b073-852b-f464987f7427 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 54868-6132-0 | 2019-09-24 | C162847 | 48780-1 | 9350213a-413f-c013-e053-90daa90a1393 | ADAPALENE GEL, 0.1% |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 54868-6132-0 | Adapalene | 45 g in 1 TUBE | GEL | 45 | 1 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 54868-6132 | ADAPALENE GEL [PHYSICIANS TOTAL CARE, INC.] | 1 | 1 package rows | 20100723_a81f2db7-78b0-45fd-93cc-b7fe43bcb45a.zip |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 54868-6132-0 | GM - Gram | 54868-6132 | ecb6d023-4916-4b76-a46e-ded825cd3a6a | 1 | 2012-07-24 |
| 0093-6301-95 | GM - Gram | 0093-6301 | 828aa75a-03df-4bc0-9bfd-9a11401bf583 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| ADAPALENE | ACTIVE INGREDIENT | 1L4806J2QF | 1 | |
| ADAPALENE | ACTIVE MOIETY | 1L4806J2QF | 1 | |
| CARBOMER HOMOPOLYMER TYPE C | INACTIVE INGREDIENT | 4Q93RCW27E | 1 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | 1 | |
| HYDROCHLORIC ACID | INACTIVE INGREDIENT | QTT17582CB | 1 | |
| METHYLPARABEN | INACTIVE INGREDIENT | A2I8C7HI9T | 1 | |
| POLOXAMER 182 | INACTIVE INGREDIENT | JX0HIX6OAG | 1 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 1 | |
| SODIUM HYDROXIDE | INACTIVE INGREDIENT | 55X04QC32I | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 1 |
Products#
Every source-derived product name is available through these pages.
- Adapalene
- CARBOMER HOMOPOLYMER TYPE C
- EDETATE DISODIUM
- METHYLPARABEN
- POLOXAMER 182
- PROPYLENE GLYCOL
- WATER
- SODIUM HYDROXIDE
- HYDROCHLORIC ACID
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 54868-6132 | 54868-6132-0 |
| 0093-6301 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| ADAPALENE | 1L4806J2QF | ACTIB |
| CARBOMER HOMOPOLYMER TYPE C | 4Q93RCW27E | IACT |
| EDETATE DISODIUM | 7FLD91C86K | IACT |
| METHYLPARABEN | A2I8C7HI9T | IACT |
| POLOXAMER 182 | JX0HIX6OAG | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SODIUM HYDROXIDE | 55X04QC32I | IACT |
| HYDROCHLORIC ACID | QTT17582CB | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER, FOR SUSPENSION / ORAL | 9 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GRANULE, FOR SUSPENSION / ORAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRA-ARTERIAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | CAPSULE / ORAL | 7 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SUSPENSION/ DROPS / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / ORAL | 2 mg/5ml | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / RESPIRATORY (INHALATION) | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / INTRADERMAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION/ DROPS / OPHTHALMIC | 0.05 %w/v | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SPRAY / NASAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / ORAL | 346 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, EMULSION / SUBCUTANEOUS | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SOLUTION / RECTAL | 0.13 %w/v | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, LIPOSOMAL / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | TABLET, FILM COATED / ORAL | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, CHEWABLE / ORAL | 1.28 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CREAM / VAGINAL | 3 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SUSPENSION / SOFT TISSUE | 1 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | INJECTION, SOLUTION / INTRAMUSCULAR | 4 mg | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | LIQUID / ORAL | 0.5 mg/1ml | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | CONCENTRATE / ORAL | 20 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION / INTRACAVITARY | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYRUP / ORAL | 81 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / INTRAMUSCULAR | 306 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION, SOLUTION / EPIDURAL | 30 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / SOFT TISSUE | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION / ENDOTRACHEAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / ORAL | 9120 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | LOTION / TOPICAL | 3392 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL / VAGINAL | 20 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / INTRAVENOUS | 18.25 mg | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | LOTION / TOPICAL | 21 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | TABLET, COATED / ORAL | 0.8 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | JELLY / TOPICAL | 420 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / INTRADERMAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CAPSULE / ORAL | 1072 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / TOPICAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / URETERAL | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | EMULSION / TOPICAL | ADJ PH | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | JELLY / TOPICAL | 20 %w/w | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | SOLUTION / ORAL | 223 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | CAPSULE / ORAL | 7 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | DROPS / NASAL | 26 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | INJECTION / SOFT TISSUE | 0.15 %w/v | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SUPPOSITORY / VAGINAL | NA | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SYSTEM / TOPICAL | 42 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, POWDER, FOR SOLUTION / PARENTERAL | ADJ PH | ||
| EDETATE DISODIUM | EDETATE DISODIUM | 7FLD91C86K | SOLUTION / TOPICAL | 1 mg | ||
| METHYLPARABEN | METHYLPARABEN | A2I8C7HI9T | SPRAY / TOPICAL | 0.2 %w/w | ||
| CARBOMER HOMOPOLYMER TYPE C | CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) | 4Q93RCW27E | GEL / OPHTHALMIC | 4 %w/w | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | POWDER / INTRAVENOUS | ADJ PH | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / EPIDURAL | ADJ PH | ||
| SODIUM HYDROXIDE | SODIUM HYDROXIDE | 55X04QC32I | GEL, METERED / TRANSDERMAL | 350 mg | ||
| HYDROCHLORIC ACID | HYDROCHLORIC ACID | QTT17582CB | INJECTION, SOLUTION / SUBCUTANEOUS | 1037 mg |
Orange Book application contexts#
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| A090962-001 | ADAPALENE | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-09-14 22:38:34 | 2026-08 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 84e616aacf4f… | ||
| 2026-08-18 06:07:40 | 2026-07 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | caaa826d4ba7… | ||
| 2026-02-19 14:30 UTC | 2026-02 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-06-02 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-06-02 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-06-02 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | AB | 2010-06-02 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | A090962-001 | ADAPALENE | 0.1% | GEL / TOPICAL | 2010-06-02 | f41ea6bd6efb… |
Observed Orange Book normalized TE history#
| Captured | Edition | Application-product | TE code | Order | Source SHA-256 |
|---|---|---|---|---|---|
| 2019-12-13 00:20 UTC | 2019-12 | A090962-001 | AB | 1 | 74a2ff9319b5… |
| 2019-12-14 00:12 UTC | 2019-12 | A090962-001 | AB | 1 | 3f01610625f2… |
| 2019-09-15 20:21 UTC | 2019-09 | A090962-001 | AB | 1 | b00525d2431f… |
| 2019-07-19 19:46 UTC | 2019-07 | A090962-001 | AB | 1 | ea99ee380514… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 1d8895b4-2882-4a9e-95fb-646e8d8d1367 | a81f2db7-78b0-45fd-93cc-b7fe43bcb45a | 2010-06-02 | Warnings, Adverse reactions | 1d8895b4-2882-4a9e-95fb-646e8d8d1367 a81f2db7-78b0-45fd-93cc-b7fe43bcb45a |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.