Calcipotriene Cream, 0.005%

Manufacturer: Prasco Laboratories | LEO Laboratories Ltd.
Effective date: 2022-12-12
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-05-31 20:45:38

Label at a glance#

ProductCalcipotriene

Active ingredientCALCIPOTRIENE

Label structure17 sections

Indications and uses

Calcipotriene Cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Dosage and administration

Apply a thin layer of Calcipotriene Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Calcipotriene Cream have been demonstrated in patients treated for eight weeks.

Storage and handling

Store at controlled room temperature 15°C - 25°C (59°F - 77°F). Do not freeze.

Contacts and useful links#

PhoneLabel contact1-877-494-4536

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FOR TOPICAL DERMATOLOGIC USE ONLY.

Rx only

Not for Ophthalmic, Oral or Intravaginal Use.

DESCRIPTION

DESCRIPTION SECTION

Calcipotriene Cream, 0.005% contains calcipotriene monohydrate, a synthetic vitamin D₃ derivative, for topical dermatological use.

Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol monohydrate, with the empirical formula C₂₇H₄₀O₃•H₂O, a molecular weight of 430.6, and the following structural formula:

Structural formula for calcipotriene monohydrate

Calcipotriene monohydrate is a white or off-white crystalline substance. Calcipotriene Cream contains calcipotriene monohydrate equivalent to 50 μg/g anhydrous calcipotriene in a cream base of cetearyl alcohol, ceteth-20, diazolidinyl urea, dichlorobenzyl alcohol, dibasic sodium phosphate, edetate disodium, dl-alpha tocopherol, glycerin, mineral oil, petrolatum, and water.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D₃ (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D₃.

Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques, or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application. Systemic absorption of the cream has not been studied.

Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D₃ (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone.

CLINICAL STUDIES

CLINICAL STUDIES SECTION

Adequate and well-controlled trials of patients treated with Calcipotriene Cream have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Calcipotriene Cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Calcipotriene Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene Cream should not be used on the face.

WARNINGS

WARNINGS SECTION

Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Cream.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Use of Calcipotriene Cream may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, Calcipotriene Cream should be discontinued.

For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.

Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Information for Patients

INFORMATION FOR PATIENTS SECTION

Patients using Calcipotriene Cream should receive the following information and instructions:

This medication is to be used only as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash their hands after application.
This medication should not be used for any disorder other than that for which it was prescribed.
Patients should report to their physician any signs of adverse reactions.
Patients that apply Calcipotriene Cream to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 µg/kg/day (corresponding to 9, 30 and 90 µg/m²/day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply Calcipotriene Cream to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients that use Calcipotriene Cream.

Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.

Studies in rats at doses up to 54 μg/kg/day (324 μg/m²/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40-60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 μg/kg/day (132 μg/m²/day). Rabbits administered 36 μg/kg/day (396 μg/m²/day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 μg/kg/day (318 μg/m²/day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 μg/m²/day) and rabbit (17.6 μg/m²/day) studies are approximately equal to the expected human systemic exposure level (18.5 μg/m²/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, Calcipotriene Cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

NURSING MOTHERS SECTION

There is evidence that maternal 1,25-dihydroxy vitamin D₃ (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin. Because many drugs are excreted in human milk, caution should be exercised when Calcipotriene Cream is administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Safety and effectiveness of Calcipotriene Cream in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.

Geriatric Use

GERIATRIC USE SECTION

Of the total number of patients in clinical studies of calcipotriene cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.

Clinical Trials Experience

SPL UNCLASSIFIED SECTION

In controlled clinical trials, the most frequent adverse experiences reported for Calcipotriene Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Postmarketing Experience

SPL UNCLASSIFIED SECTION

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions associated with the use of Calcipotriene Cream have been identified post-approval: contact dermatitis including allergic contact dermatitis.

OVERDOSAGE

OVERDOSAGE SECTION

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored. (See PRECAUTIONS.)

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Calcipotriene Cream, 0.005% is available in:

60 gram aluminum tubes (NDC 66993-877-61)

120 gram aluminum tubes (NDC 66993-877-78)

STORAGE

STORAGE AND HANDLING SECTION

Store at controlled room temperature 15°C - 25°C (59°F - 77°F). Do not freeze.

SPL UNCLASSIFIED SECTION

Prasco-Logo

Manufactured for: Prasco Laboratories, Mason, OH 45040 USA

Manufactured by: LEO Laboratories Ltd., Dublin 12, Ireland

To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma

Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

Revised 06/2017

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 66993-877-61

PRASCO

Calcipotriene Cream, 0.005%

Net Wt. 60 g

Rx only

PRINCIPAL DISPLAY PANEL - 60 g Tube Carton

Principal Display Panel - 120 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PRASCO

NDC 66993-877-78

Calcipotriene Cream 0.005%

Net Wt. 120 g

Rx only

Principal Display Panel - 120 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
313921	calcipotriene 0.005 % Topical Cream	PSN	10
313921	calcipotriene 0.05 MG/ML Topical Cream	SCD	10
313921	calcipotriene (as calcipotriene monohydrate) 0.005 % Topical Cream	SY	10
313921	calcipotriene 0.005 % Topical Cream	SY	10

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
bbdc14c7-d940-43b5-a2f7-36c425991f3c	Product name	1	20240320
4d1338f1-f50a-5bb5-4946-11534fdee48f	Product name	2	20210527
7fea2046-07a9-4bb6-9409-828ac6f1f6df	Product name	1	20210201
f059f1a2-0e64-4839-9a7f-42687c91a44b	Product name	1	20201007
c148aeb5-688c-9b49-a40f-30a41e3595e4	Product name	2	20180419
07737a91-49bd-c707-82e4-7a6a1660aef6	Product name	2	20150616
6f16fc1e-e77d-460f-8810-a12ca121425c	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
66993-877-61	Calcipotriene	1 in 1 CARTON	CREAM	1	10
66993-877-61	Calcipotriene	60 g in 1 TUBE	CREAM	60	10
66993-877-78	Calcipotriene	120 g in 1 TUBE	CREAM	120	10
66993-877-78	Calcipotriene	1 in 1 CARTON	CREAM	1	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
66993-877	CALCIPOTRIENE CREAM [PRASCO LABORATORIES]	10	Current NDC, Legacy NDC, 4 package rows	20221213_377eafda-737c-4ba2-9ec5-61209b8814ed.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
66993-877-61	GM - Gram	66993-877	01e3dce0-cd1c-4456-b145-3949f62c4491	1	2013-02-13
66993-877-78	GM - Gram	66993-877	51370a47-3635-4678-82be-6599528acc5c	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CALCIPOTRIENE	ACTIVE INGREDIENT	143NQ3779B	2
CALCIPOTRIENE	ACTIVE MOIETY	143NQ3779B	2
ALPHA-TOCOPHEROL, DL-	INACTIVE INGREDIENT	7QWA1RIO01	2
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	2
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	2
DICHLOROBENZYL ALCOHOL	INACTIVE INGREDIENT	1NKX3648J9	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	2
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	2
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	2
SODIUM PHOSPHATE, DIBASIC	INACTIVE INGREDIENT	GR686LBA74	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	2

Products#

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

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

Calcipotriene
CETOSTEARYL ALCOHOL
CETETH-20
DICHLOROBENZYL ALCOHOL
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM
EDETATE DISODIUM
GLYCERIN
MINERAL OIL
PETROLATUM
WATER
.ALPHA.-TOCOPHEROL, DL-
DIAZOLIDINYL UREA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
66993-877	66993-877-61, 66993-877-78

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
CALCIPOTRIENE	143NQ3779B	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CETETH-20	I835H2IHHX	IACT
DICHLOROBENZYL ALCOHOL	1NKX3648J9	IACT
SODIUM PHOSPHATE, DIBASIC, UNSPECIFIED FORM	GR686LBA74	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
GLYCERIN	PDC6A3C0OX	IACT
MINERAL OIL	T5L8T28FGP	IACT
PETROLATUM	4T6H12BN9U	IACT
WATER	059QF0KO0R	IACT
.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	IACT
DIAZOLIDINYL UREA	H5RIZ3MPW4	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 1 · 30 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
ALPHA-TOCOPHEROL, DL-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ALPHA-TOCOPHEROL, DL-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	AEROSOL, FOAM / TOPICAL	0.02 mg		Exact identifier — unii+route 6 equally ranked IID candidates
ALPHA-TOCOPHEROL, DL-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	AEROSOL, FOAM / TOPICAL	0.02 mg		Exact identifier — unii+route 6 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	CREAM / TOPICAL		429 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	CREAM / TOPICAL		429 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ALPHA-TOCOPHEROL, DL-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
ALPHA-TOCOPHEROL, DL-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	AEROSOL, FOAM / TOPICAL	0.02 mg		Exact identifier — unii+route 6 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC	SODIUM PHOSPHATE, DIBASIC	GR686LBA74	CREAM / TOPICAL	0.1 %w/w		Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
DICHLOROBENZYL ALCOHOL	DICHLOROBENZYL ALCOHOL	1NKX3648J9	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
ALPHA-TOCOPHEROL, DL-	.ALPHA.-TOCOPHEROL, DL-	7QWA1RIO01	OINTMENT / TOPICAL	NA		Exact identifier — unii+route 6 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	CREAM / TOPICAL		429 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
DICHLOROBENZYL ALCOHOL	DICHLOROBENZYL ALCOHOL	1NKX3648J9	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
DICHLOROBENZYL ALCOHOL	DICHLOROBENZYL ALCOHOL	1NKX3648J9	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii+route+dosage form 3 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 44.

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
N020554-001	DOVONEX	CALCIPOTRIENE	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
N020554-001	AB

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 · 44 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
2026-10-15 13:18:30	2026-09	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020554-001	DOVONEX	0.005%	CREAM / TOPICAL	AB	RLD, RS	1996-07-22	`3a93d1ddd44b…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 44 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-10-15 13:18:30	2026-09	N020554-001	AB	1	`c2088c7a36db…`
2026-09-14 22:38:34	2026-08	N020554-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N020554-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N020554-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N020554-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N020554-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N020554-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N020554-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N020554-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N020554-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N020554-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N020554-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N020554-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N020554-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N020554-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N020554-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N020554-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N020554-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N020554-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N020554-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N020554-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N020554-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N020554-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N020554-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N020554-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N020554-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N020554-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N020554-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N020554-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N020554-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N020554-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N020554-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N020554-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N020554-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N020554-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N020554-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N020554-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N020554-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N020554-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N020554-001	AB	1	`3a93d1ddd44b…`

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
Calcipotriene	CALCIPOTRIENE	Prasco Laboratories	377eafda-737c-4ba2-9ec5-61209b8814ed	2022-12-12	Warnings, Adverse reactions	Exact identifier ndc (package): 66993-877-61 ndc (package): 66993-877-78 ndc (product): 66993-877 ndc11 (package): 66993087761 ndc11 (package): 66993087778 spl id: 3682f2c5-9bce-4b4a-a4d6-9af29f08ad63 spl set id: 377eafda-737c-4ba2-9ec5-61209b8814ed

Reported adverse events (FAERS/openFDA)#

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