Adapalene Gel, 0.1%

Manufacturer: Taro Pharmaceuticals U.S.A., Inc. | G Production, Inc.
Effective date: 2014-07-01
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:34:45

Label at a glance#

ProductAdapalene

Active ingredientAdapalene

Label structure13 sections

Indications and uses

Adapalene gel is indicated for the topical treatment of acne vulgaris.

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#

SPL UNCLASSIFIED SECTION

Rx Only.

DESCRIPTION:

DESCRIPTION SECTION

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 940, edetate disodium, 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. The molecular formula is C₂₈H₂₈O₃ and molecular weight is 412.52.

Adapalene is represented by the following structural formula:

chem-stuct

CLINICAL PHARMACOLOGY:

CLINICAL PHARMACOLOGY SECTION

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:

PHARMACOKINETICS SECTION

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:

INDICATIONS & USAGE SECTION

Adapalene gel is indicated for the topical treatment of acne vulgaris.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

Adapalene gel should not be administered to individuals who are hypersensitive to adapalene or any of the components in the vehicle gel.

WARNINGS:

WARNINGS SECTION

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:

PRECAUTIONS SECTION

General:

GENERAL PRECAUTIONS SECTION

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:

DRUG INTERACTIONS SECTION

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:

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

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:

PREGNANCY SECTION

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:

NURSING MOTHERS SECTION

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:

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients below the age of 12 have not been established.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

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:

OVERDOSAGE SECTION

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:

DOSAGE & ADMINISTRATION SECTION

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:

HOW SUPPLIED SECTION

Adapalene gel, 0.1% is supplied in the following size:

45 g laminate tube - NDC 51672-4155-6

Storage:

STORAGE AND HANDLING SECTION

Store at controlled room temperature 68° - 77°F (20° - 25°C), excursions permitted between 59° - 86°F (15° - 30°C). Protect from freezing.

SPL UNCLASSIFIED SECTION

Manufactured by:

G Production Inc.

Baie d'Urfé, QC, H9X 3S4 Canada

Distributed by:

Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

Made in Canada.

Revised: 07/2013

P51512-0

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

P51511-0-adap-gel-crtn-usa-v2

Each gram contains: adapalene 0.1% (1 mg) in a vehicle consisting of carbomer 940, edetate disodium, methylparaben, poloxamer 182, propylene glycol, purified water, and sodium hydroxide. May contain hydrochloric acid to adjust pH.

Usual dosage: Apply a thin film once a day to afffected areas after washing in the evening before retiring.

See package insert for complete prescribing information. See carton closure for lot number and expiration date.

Store at controlled room temperature 68° to 77°F (20° - 25°C), excursions permitted between 59° - 86°F (15° - 30°C).

NDC 51672-4155-6

Net Wt. 45 g

Adapalene
Gel 0.1%

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Rx Only TARO

Keep this and all medications out of the reach of children.

Manufactured by:

G Production Inc.

Baie d'Urfé, QC, H9X 3S4 Canada

Made in Canada

Distributed by:

Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532

TARO is a registered trademark of Taro Pharmaceuticals U.S.A., Inc.

P51511-0 Rev. 07/2013

LOT:

EXP:

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
51672-4155-6	GM - Gram	51672-4155	e4787a48-1b55-4533-af98-29b9f594df7b	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Adapalene	ACTIVE INGREDIENT	1L4806J2QF	3
Adapalene	ACTIVE MOIETY	1L4806J2QF	3
CARBOMER 940	INACTIVE INGREDIENT	4Q93RCW27E	3
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	3
HYDROCHLORIC ACID	INACTIVE INGREDIENT	QTT17582CB	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLOXAMER 182	INACTIVE INGREDIENT	JX0HIX6OAG	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
SODIUM HYDROXIDE	INACTIVE INGREDIENT	55X04QC32I	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

Adapalene
CARBOMER 940
EDETATE DISODIUM
METHYLPARABEN
POLOXAMER 182
PROPYLENE GLYCOL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
51672-4155	51672-4155-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Adapalene	1L4806J2QF	ACTIB
CARBOMER 940	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#

Source XML

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.

Inactive ingredient links page 1 of 10 · 569 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / SOFT TISSUE	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRAVITREAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRAOCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SHAMPOO / TOPICAL		3 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION / RECTAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRADISCAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SUSPENSION / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRATHECAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION, EXTENDED RELEASE / INTRASYNOVIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SYSTEM / TOPICAL		42 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	OINTMENT, AUGMENTED / TOPICAL		23 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	CAPSULE / ORAL	60 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LOTION, AUGMENTED / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / INTRATUMOR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	63.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INTRA-ARTICULAR	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SUSPENSION / ORAL	400 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / TOPICAL	0.16 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SYRUP / ORAL	71 mg/5ml		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LIQUID / ORAL		162 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	AEROSOL, SPRAY / RESPIRATORY (INHALATION)	1.5 %w/w		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION, SOLUTION / SUBARACHNOID	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRACARDIAC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	LOTION / TOPICAL		300 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / INFILTRATION		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / TOPICAL		4886 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / SOFT TISSUE	0.15 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION/ DROPS / OPHTHALMIC	0.13 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	CREAM / TOPICAL		103 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / INTRA-ARTERIAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRA-AMNIOTIC	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION / INTRATHECAL	176 mg		Exact identifier — unii candidate 174 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SUSPENSION/ DROPS / OPHTHALMIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / PARENTERAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / RESPIRATORY (INHALATION)	0.01 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	OINTMENT / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	OINTMENT, AUGMENTED / TOPICAL	0.11 %w/w		Exact identifier — unii candidate 174 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	AEROSOL, FOAM / VAGINAL	0.1 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRALESIONAL	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	SOLUTION / DENTAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
CARBOMER 940	CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)	4Q93RCW27E	GEL / TRANSDERMAL		150 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	POWDER, FOR SOLUTION / ORAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET / ORAL		64 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	TABLET / ORAL		10 mg	Exact identifier — unii candidate 174 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	LIQUID / TOPICAL	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates
HYDROCHLORIC ACID	HYDROCHLORIC ACID	QTT17582CB	INJECTION / INTRA-AMNIOTIC	ADJ PH		Exact identifier — unii candidate 148 equally ranked IID candidates
SODIUM HYDROXIDE	SODIUM HYDROXIDE	55X04QC32I	INJECTION, SUSPENSION / INTRAMUSCULAR	ADJ PH		Exact identifier — unii candidate 174 equally ranked IID candidates

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N020380-002	DIFFERIN	ADAPALENE	0.1%	GEL / TOPICAL		RLD, RS	2016-07-08

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N020380-002	DIFFERIN	0.1%	GEL / TOPICAL	RLD, RS	2016-07-08	`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N020380-002	RTO	2019-07-08	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N020380-002	RTO	2019-07-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020380-002	RTO	2019-07-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020380-002	RTO	2019-07-08	`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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
63a5f8f2-6a08-447c-80f5-8a2f390074ab			e87a2f9b-33eb-4861-b301-d1d21c2c326d	2019-11-15	Warnings, Adverse reactions	Exact identifier spl set id: e87a2f9b-33eb-4861-b301-d1d21c2c326d

Reported adverse events (FAERS/openFDA)#

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