Desonide Lotion 0.05%

Manufacturer: Physicians Total Care, Inc.
Effective date: 2009-06-15
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 20:11:31

Label at a glance#

ProductDesonide

Active ingredientDESONIDE

Label structure19 sections

Dosage and administration

Desonide Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING. As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Desonide Lotion should not be used with occlusive dressings.

Storage and handling

Store between 2° and 30°C (36° and 86°F). Distributed by: Actavis Mid Atlantic LLC 1877 Kawai Road Lincolnton, NC 28092 USA Manufactured by DPT Laboratories, Ltd. San Antonio, Texas 78215 USA 325097-0209 Revised: February 2009 Relabeling of "Additional" barcode label by: Physicians Total Care, Inc. Tulsa, OK 74146

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only
For Dermatologic Use Only
Not for Ophthalmic Use

DESCRIPTION

DESCRIPTION SECTION

Desonide Lotion 0.05% contains desonide (Pregna-1,4-diene-3,20-dione,11,21-dihydroxy-16,17 -[(1-melhylethylidene)bis(oxy)]-,(11β, 16α)- a synthetic nonfluorinated corticosteroid for topical dermatologic use. The corticosteroids constitute a class of primarily synthetic steroids used topically as anti-inflammatory and anti-pruritic agents.
Chemically, desonide is C₂₄H₃₂0₆. It has the following structural formula:

Desonide has the molecular weight of 416.51. It is a white to off white odorless powder which is soluble in methanol and practically insoluble in water. Each gram of Desonide Lotion contains 0.5 mg of desonide in a base of cetyl alcohol, edetate sodium, glyceryl stearate SE, light mineral oil, methylparaben, propylene glycol, propylparaben, purified water, sodium lauryl sulfate, sorbitan monostearate, and stearyl alcohol. May contain citric acid and/or sodium hydroxide for pH adjustment.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Like other topical corticosteroids, desonide has anti-inflammatory, antipruritic and vasoconstrictive properties. The mechanism of the anti-inflammatory activity of the topical steroids, in general, is unclear. However, corticosteroids are thought to act by the induction of phospholipase A₂ inhibitory proteins, collectively called lipocortins. It is postulated that these proteins control the biosynthesis of potent mediators of inflammation such as prostaglandins and leukotrienes by inhibiting the release of their common precursor arachidonic acid. Arachidonic acid is released from membrane phospholipids by phospholipase A_2.

Pharmacokinetics

PHARMACOKINETICS SECTION

The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle and the integrity of the epidermal barrier. Occlusive dressings with hydrocortisone for up to 24 hours have not been demonstrated to increase penetration; however, occlusion of hydrocortisone for 96 hours markedly enhances penetration. Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin may increase percutaneous absorption.
Studies performed with Desonide Lotion indicate that it is in the low to medium range of potency as compared with other topical corticosteroids.

INDICATION AND USAGE

INDICATIONS & USAGE SECTION

Desonide Lotion is low to medium potency corticosteroids indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Desonide lotion is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparations.

PRECAUTIONS

PRECAUTIONS SECTION

General: Systemic absorption of topical corticosteroids can produce reversible hypothalamic-pituitary-adrenal (HPA) axis suppression with the potential for glucocorticosteroid insufficiency after withdrawal of treatment. Manifestations of Cushing's syndrome, hyperglycemia, and glucosuria can also be produced in some patients by systemic absorption of topical corticosteroids while on treatment. Patients applying a topical steroid to a large surface area or to areas under occlusion should be evaluated periodically for evidence of HPA axis suppression. This may be done by using the ACTH stimulation, A.M. plasma cortisol, and urinary free cortisol tests. Patients receiving superpotent corticosteroids should not be treated for more than 2 weeks at a time and only small areas should be treated at any one time due to the increased risk of HPA axis suppression.
If HPA axis suppression is noted, an attempt should be made to withdraw the drug, to reduce the frequency of application, or to substitute a less potent corticosteroid. Recovery of HPA axis function is generally prompt and complete upon discontinuation of topical corticosteroids. Infrequently, signs and symptoms of glucocorticosteroid insufficiency may occur requiring supplemental systemic corticosteroids. For information on systemic supplementation, see prescribing information for those products.
Pediatric patients may be more susceptible to systemic toxicity from equivalent doses due to their larger skin surface to body mass ratios. (See PRECAUTIONS: Pediatric Use).
If irritation develops, Desonide Lotion should be discontinued and appropriate therapy instituted. Allergic contact dermatitis with corticosteroids is usually diagnosed by observing failure to heal rather than noting a clinical exacerbation as with most topical products not containing corticosteroids. Such an observation should be corroborated with appropriate diagnostic patch testing.
If concomitant skin infections are present or develop, an appropriate antifungal or antibacterial agent should be used. If a favorable response does not occur promptly, use of Desonide Lotion should be discontinued until the infection has been adequately controlled.

Information for patients

INFORMATION FOR PATIENTS SECTION

Patients using topical corticosteroids should receive the following information and Instructions:
1. This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
2. This medication should not be used for any disorder other than that for which it was prescribed.
3. The treated skin area should not be bandaged or otherwise covered or wrapped so as to be occlusive unless directed by the physician.
4. Patients should report to their physician any signs of local adverse reactions.

Laboratory tests

LABORATORY TESTS SECTION

The following tests may be helpful in evaluating patients for HPA axis suppression:
ACTH stimulation test
A.M. plasma cortisol test
Urinary free cortisol test

Carcinogenesis, mutagenesis, and impairment or fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on reproduction with the use of Desonide Lotion.

Pregnancy

PREGNANCY SECTION

Teratogenic effects: Pregnancy category C:
Corticosteroids have been shown to be teratogenic in laboratory animals when administered systemically at relativity low dosage levels. Some corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. Animal reproduction studies have not been conducted with Desonide Lotion. It is also not known whether Desonide Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Desonide Lotion should be given to a pregnant woman only if clearly needed.

Nursing mothers

NURSING MOTHERS SECTION

Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Desonide Lotion is administered to a nursing woman.

Pediatric use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at a greater risk than adults of HPA axis suppression when they are treated with topical corticosteroids. They are therefore also at greater risk of glucocorticosteroid insufficiency after withdrawal of treatment and of Cushing's syndrome while on treatment. Adverse effects including striae have been reported with inappropriate use of topical corticosteroids in infants and children.
HPA axis suppression, Cushing's syndrome, linear growth retardation, delayed weight gain and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in children include low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches, and bilateral papilledema.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

In controlled clinical trials, the total incidence of adverse reactions associated with the use of desonide was approximately 8%. These were: stinging and burning approximately 3%. Irritation, contact dermatitis, condition worsened, peeling of skin, itching, intense transient erythema, and dryness/scaliness, each less than 2%.
The following additional local adverse reactions have been reported infrequently with other topical corticosteroids, and they may occur more frequently with the use of occlusive dressings, especially with higher potency corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: folliculitis, acneiform eruptions, hypopigmentation, perioral dermatitis, secondary infection, skin atrophy, striae, and miliaria.

OVERDOSAGE

OVERDOSAGE SECTION

Topically applied Desonide Lotion can be absorbed in sufficient amounts to produce systemic effects (see PRECAUTIONS)

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Desonide Lotion should be applied to the affected areas as a thin film two or three times daily depending on the severity of the condition. SHAKE LOTION WELL BEFORE USING.
As with other corticosteroids, therapy should be discontinued when control is achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary.
Desonide Lotion should not be used with occlusive dressings.

HOW SUPPLIED

HOW SUPPLIED SECTION

Desonide Lotion 0.05% is supplied as follows:

2 fl oz / 59 mL	NDC 54868-5050-1
4 fl oz / 118 mL	NDC 54868-5050-0

Storage Conditions

STORAGE AND HANDLING SECTION

Store between 2° and 30°C (36° and 86°F).

Distributed by:
Actavis Mid Atlantic LLC
1877 Kawai Road
Lincolnton, NC 28092 USA

Manufactured by
DPT Laboratories, Ltd.
San Antonio, Texas 78215 USA

325097-0209 Revised: February 2009

Relabeling of "Additional" barcode label by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 54868-5050-0

Desonide Lotion 0.05%

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
197572	desonide 0.05 % Topical Lotion	PSN	1
197572	desonide 0.5 MG/ML Topical Lotion	SCD	1
197572	desonide 0.05 % Topical Lotion	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DESONIDE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
5dd568b3-c283-39c3-9c72-0b51d8c13e5d	Product name	2	20201006
0d789796-3334-08b7-795a-b9c3762179bc	Product name	2	20200506
6da396dc-a1b2-d109-14be-877a0fdbfa18	Product name	5	20200408
4fa39b20-3e53-46d7-85e4-edc2360cfdff	Product name	1	20171115
a4783074-7e0b-e965-10c3-0421e26d5ede	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-5050-0	2019-09-24	C162847	48780-1	9350213a-430a-c013-e053-90daa90a1393	Desonide Lotion 0.05%
54868-5050-1	2019-09-24	C162847	48780-1	9350213a-430a-c013-e053-90daa90a1393	Desonide Lotion 0.05%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-5050-0	Desonide	120 g in 1 BOTTLE, PLASTIC	LOTION	120		1
54868-5050-1	Desonide	60 g in 1 BOTTLE, PLASTIC	LOTION	60		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-5050	DESONIDE LOTION [PHYSICIANS TOTAL CARE, INC.]	1	2 package rows	20110321_1de8eee6-2556-484c-bbcd-ae764b7d586e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-5050-0	ML - Milliliter	54868-5050	70923235-d124-4507-9b82-6e2758742361	1	2012-07-24
54868-5050-1	ML - Milliliter	54868-5050	ef5f21a4-c79f-4089-83f3-bf241de20190	1	2012-07-24
0472-0803-02	ML - Milliliter	0472-0803	b5d2dba3-5284-4757-b691-ecabc4452c52	1	2012-07-24
0472-0803-04	ML - Milliliter	0472-0803	56f59582-de71-4216-a843-0a633bd77d48	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DESONIDE	ACTIVE INGREDIENT	J280872D1O	1
DESONIDE	ACTIVE MOIETY	J280872D1O	1
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	1
EDETATE SODIUM	INACTIVE INGREDIENT	MP1J8420LU	1
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	1
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Desonide
CETYL ALCOHOL
EDETATE SODIUM
GLYCERYL MONOSTEARATE
LIGHT MINERAL OIL
METHYLPARABEN
PROPYLENE GLYCOL
PROPYLPARABEN
SODIUM LAURYL SULFATE
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-5050	54868-5050-0, 54868-5050-1
0472-0803

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
DESONIDE	J280872D1O	ACTIB
CETYL ALCOHOL	936JST6JCN	IACT
EDETATE SODIUM	MP1J8420LU	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

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 1 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SORBITAN MONOSTEARATE	SORBITAN MONOSTEARATE	NVZ4I0H58X	LOTION / TOPICAL		89 mg	Exact identifier — unii+route+dosage form
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	LOTION / TOPICAL		111 mg	Exact identifier — unii+route+dosage form
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	LOTION / TOPICAL		140 mg	Exact identifier — unii+route+dosage form
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LOTION / TOPICAL		3392 mg	Exact identifier — unii+route+dosage form
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	LOTION / TOPICAL		177 mg	Exact identifier — unii+route+dosage form
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	LOTION / TOPICAL		351 mg	Exact identifier — unii+route+dosage form
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii+route+dosage form
EDETATE SODIUM	EDETATE SODIUM	MP1J8420LU	LOTION / TOPICAL	0.17 %w/w		Exact identifier — unii+route+dosage form
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii+route+dosage form

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
A072354-001	DESOWEN	DESONIDE	0.05%	LOTION / TOPICAL			1992-01-24

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	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL			1992-01-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL			1992-01-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL			1992-01-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL			1992-01-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072354-001	DESOWEN	0.05%	LOTION / TOPICAL	AB	RS	1992-01-24	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2025-08-23 18:47 UTC	2025-08	A072354-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A072354-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A072354-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A072354-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A072354-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A072354-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A072354-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A072354-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A072354-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A072354-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A072354-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A072354-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A072354-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A072354-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A072354-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A072354-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A072354-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A072354-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A072354-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A072354-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A072354-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A072354-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A072354-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A072354-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A072354-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A072354-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A072354-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A072354-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A072354-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A072354-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A072354-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A072354-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A072354-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A072354-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A072354-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A072354-001	AB	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A072354-001	AB	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A072354-001	AB	1	`cb3db0bc1861…`

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 · 2 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Desonide	DESONIDE	Actavis Pharma, Inc.	ff5d4cd8-ab4d-4a9e-b84b-445c81eeea99	2025-09-08	Adverse reactions	Exact identifier ndc (product): 0472-0803
4efaae7a-6bfd-4ff3-bdad-384c7a414047			1de8eee6-2556-484c-bbcd-ae764b7d586e	2009-06-15	Adverse reactions	Exact identifier spl id: 4efaae7a-6bfd-4ff3-bdad-384c7a414047 spl set id: 1de8eee6-2556-484c-bbcd-ae764b7d586e

Reported adverse events (FAERS/openFDA)#

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