HYDROCORTISONE CREAM USP, 2.5%

Manufacturer: Actavis Pharma, Inc.
Effective date: 2020-10-27
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 20:33:45

Label at a glance#

ProductHydrocortisone

Active ingredientHYDROCORTISONE

Label structure11 sections

Indications and uses

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Dosage and administration

Topical corticosteroids are generally applied to the affected area as a thin film from 2 to 4 times daily depending on the severity of the condition. Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions. If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Contacts and useful links#

PhoneLabel contact1-888-838-2872

PhoneFDA MedWatch1-800-FDA-1088

Websitewww.fda.gov

www.fda.gov/medwatch

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

FOR EXTERNAL USE ONLY • NOT FOR OPHTHALMIC USE

Rx only

DESCRIPTION

DESCRIPTION SECTION

The topical corticosteroids constitute a class of primarily synthetic steroids used as anti-inflammatory and anti-pruritic agents. Hydrocortisone cream is a member of this class. Hydrocortisone cream contains the synthetic steroid hydrocortisone (Pregn-4-ene-3,20-dione, 11, 17, 21-trihydroxy-, (11ß)-) which has a molecular formula of C₂₁H₃₀O₅, a molecular weight of 362.46 and CAS Registry Number 50-23-7.

Each gram of the 2.5% cream contains 25 mg of hydrocortisone, USP in a cream base of cetyl alcohol, citric acid, glyceryl stearate, isopropyl myristate, methylparaben, polyoxyl 40 stearate, polysorbate 60, propylene glycol, propylparaben, purified water, sodium citrate, sorbic acid, sorbitan monostearate, stearyl alcohol, white wax and citric acid solution and sodium citrate solution to adjust pH.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and to predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

Pharmacokinetics: The extent of percutaneous absorption of topical corticosteroids is determined by many factors including the vehicle, the integrity of the epidermal barrier, and the use of occlusive dressings.

Topical corticosteroids can be absorbed from normal intact skin. Inflammation and/or other disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Thus, occlusive dressings may be a valuable therapeutic adjunct for treatment of resistant dermatoses (see DOSAGE AND ADMINISTRATION). Once absorbed through the skin, topical corticosteroids are handled through pharmacokinetic pathways similar to systemically administered corticosteroids. Corticosteroids are bound to plasma proteins in varying degrees. Corticosteroids are metabolized primarily in the liver and are then excreted by the kidneys. Some of the topical corticosteroids and their metabolites are also excreted into the bile.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Topical corticosteroids are indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Systemic absorption of topical corticosteroids has produced reversible hypothalamic-pituitary-adrenal (HPA) axis suppression, manifestations of Cushing’s syndrome, hyperglycemia and glucosuria in some patients.

Conditions which augment systemic absorption include the application of the more potent steroids, use over large surface areas, prolonged use, and the addition of occlusive dressings.

Therefore, patients receiving a large dose of a potent topical steroid applied to a large surface area or under an occlusive dressing should be evaluated periodically for evidence of HPA axis suppression by using the urinary free cortisol and ACTH stimulation tests. 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 steroid.

Recovery of HPA axis function is generally prompt and complete upon discontinuation of the drug. Infrequently, signs and symptoms of steroid withdrawal may occur, requiring supplemental systemic corticosteroids.

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity (see PRECAUTIONS–Pediatric Use).

If irritation develops, topical corticosteroids should be discontinued and appropriate therapy instituted. In the presence of dermatological infections, the use of an appropriate antifungal or antibacterial agent should be instituted. If a favorable response does not occur promptly, the corticosteroid should be discontinued until the infection has been adequately controlled.

Information for the Patient

INFORMATION FOR PATIENTS SECTION

Patients using topical corticosteroids should receive the following information and instructions.

This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Patients should be advised not to use this medication for any disorder other than for which it was prescribed.
The treated skin area should not be bandaged or otherwise covered or wrapped as to be occlusive unless directed by the physician.
Patients should report any signs of local adverse reactions especially under occlusive dressing.
Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Laboratory Tests

LABORATORY TESTS SECTION

The following tests may be helpful in evaluating the HPA axis suppression: Urinary free cortisol test; ACTH stimulation test.

Carcinogenesis, Mutagenesis, Impairment of Fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term animal studies have not been performed to evaluate the carcinogenic potential or the effect on fertility of topical corticosteroids.

Studies to determine mutagenicity with prednisolone and hydrocortisone have revealed negative results.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects:

TERATOGENIC EFFECTS SECTION

Corticosteroids are generally teratogenic in laboratory animals when administered systemically at relatively low dosage levels. The more potent corticosteroids have been shown to be teratogenic after dermal application in laboratory animals. There are no adequate and well-controlled studies in pregnant women on teratogenic effects from topically applied corticosteroids. Therefore, topical corticosteroids should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Drugs of this class should not be used extensively on pregnant patients, in large amounts, or for prolonged periods of time.

Nursing Mothers

NURSING MOTHERS SECTION

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Systemically administered corticosteroids are secreted into breast milk in quantities not likely to have a deleterious effect on the infant. Nevertheless, caution should be exercised when topical corticosteroids are administered to a nursing woman.

Pediatric Use

PEDIATRIC USE SECTION

Pediatric patients may demonstrate greater susceptibility to topical corticosteroid-induced HPA axis suppression and Cushing’s syndrome than mature patients because of a larger skin surface area to body weight ratio.

Hypothalamic-pituitary-adrenal (HPA) axis suppression, Cushing’s syndrome and intracranial hypertension have been reported in children receiving topical corticosteroids. Manifestations of adrenal suppression in pediatric patients include linear growth retardation, delayed weight gain, low plasma cortisol levels, and absence of response to ACTH stimulation. Manifestations of intracranial hypertension include bulging fontanelles, headaches and bilateral papilledema.

Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of children.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infection, skin atrophy, striae and miliaria.

To report SUSPECTED ADVERSE EVENTS, contact Actavis at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

OVERDOSAGE

OVERDOSAGE SECTION

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

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Topical corticosteroids are generally applied to the affected area as a thin film from 2 to 4 times daily depending on the severity of the condition.

Occlusive dressings may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

HOW SUPPLIED

HOW SUPPLIED SECTION

Hydrocortisone Cream USP, 2.5%

20 g (0.7 oz) tube NDC 0472-0337-20

30 g (1.1 oz) tube NDC 0472-0337-30

Store at controlled room temperature 15° to 30°C (59° to 86°F). Do not freeze.

Distributed by:
Actavis Pharma, Inc.
Parsippany, NJ 07054 USA

Rev. A 7/2020

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0472-0337-20

Hydrocortisone Cream USP 2.5%

Rx Only

For External Use Only
Not for Ophthalmic Use

20g (0.7 oz)

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
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9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
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e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
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DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0472-0337	HYDROCORTISONE CREAM [ACTAVIS PHARMA, INC.]	7	Legacy NDC, 4 package rows	20201028_a5f16c13-2a51-4541-bf9e-d80bc01a8dbd.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0472-0337-20	GM - Gram	0472-0337	af6288de-360f-41d8-b6bc-83a7a608289a	1	2013-02-11
0472-0337-30	GM - Gram	0472-0337	eb52ef36-7668-491b-a1b7-9bf6734f883d	1	2013-02-11

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	3
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	3
ANHYDROUS CITRIC ACID	INACTIVE INGREDIENT	XF417D3PSL	3
CETYL ALCOHOL	INACTIVE INGREDIENT	936JST6JCN	3
GLYCERYL MONOSTEARATE	INACTIVE INGREDIENT	230OU9XXE4	3
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	3
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	3
POLYOXYL 40 STEARATE	INACTIVE INGREDIENT	13A4J4NH9I	3
POLYSORBATE 60	INACTIVE INGREDIENT	CAL22UVI4M	3
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	3
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	3
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	3
SORBIC ACID	INACTIVE INGREDIENT	X045WJ989B	3
SORBITAN MONOSTEARATE	INACTIVE INGREDIENT	NVZ4I0H58X	3
STEARYL ALCOHOL	INACTIVE INGREDIENT	2KR89I4H1Y	3
WATER	INACTIVE INGREDIENT	059QF0KO0R	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	3

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

Hydrocortisone
CETYL ALCOHOL
CITRIC ACID MONOHYDRATE
GLYCERYL MONOSTEARATE
ISOPROPYL MYRISTATE
METHYLPARABEN
POLYOXYL 40 STEARATE
POLYSORBATE 60
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
SODIUM CITRATE
SORBIC ACID
SORBITAN MONOSTEARATE
STEARYL ALCOHOL
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0472-0337	0472-0337-20, 0472-0337-30

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
HYDROCORTISONE	WI4X0X7BPJ	ACTIB
CETYL ALCOHOL	936JST6JCN	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYOXYL 40 STEARATE	13A4J4NH9I	IACT
POLYSORBATE 60	CAL22UVI4M	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
SODIUM CITRATE	1Q73Q2JULR	IACT
SORBIC ACID	X045WJ989B	IACT
SORBITAN MONOSTEARATE	NVZ4I0H58X	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
WHITE WAX	7G1J5DA97F	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
8	2020-07-01	full-release	2026-05-31 22:04:54

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 8 · 431 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, CHEWABLE / ORAL	NA		Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	TABLET, COATED / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION / RESPIRATORY (INHALATION)	25 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERIDURAL	1 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OIL / AURICULAR (OTIC)		36 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CAPSULE, EXTENDED RELEASE / ORAL	32.4 mg		Exact identifier — unii candidate 21 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / INTRAVENOUS	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE / ORAL		1072 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / SOFT TISSUE	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / VAGINAL		140 mg	Exact identifier — unii candidate 21 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	SUSPENSION / RESPIRATORY (INHALATION)		1 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	FILM / SUBLINGUAL		11 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CONCENTRATE / ORAL		84 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	EMULSION / ORAL	NA		Exact identifier — unii candidate 21 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SUSPENSION / AURICULAR (OTIC)	10 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PERINEURAL		80 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERYL MONOSTEARATE	GLYCERYL MONOSTEARATE	230OU9XXE4	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 21 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRALESIONAL	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / INTRAMUSCULAR		4000 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	OINTMENT / OPHTHALMIC	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CREAM / TOPICAL		1280 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	LOTION / TOPICAL	3 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
CETYL ALCOHOL	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	CLOTH / TOPICAL	4.2 mg		Exact identifier — unii candidate 61 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / ORAL	100 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / NASAL	26 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SUSPENSION / SUBCUTANEOUS	0.02 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	FILM, EXTENDED RELEASE / TRANSDERMAL	20.4 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	PASTE / DENTAL	0.5 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
POLYSORBATE 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	SUSPENSION / ORAL		40 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / RESPIRATORY (INHALATION)	0.01 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / TOPICAL	0.24 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	0.4 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, EFFERVESCENT / ORAL		840 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE / ORAL		1 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	EMULSION / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 68 equally ranked IID candidates
POLYOXYL 40 STEARATE	POLYOXYL 40 STEARATE TYPE I	13A4J4NH9I	AEROSOL, FOAM / TOPICAL	2.83 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
STEARYL ALCOHOL	STEARYL ALCOHOL	2KR89I4H1Y	OINTMENT / TOPICAL		569 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
SORBIC ACID	SORBIC ACID	X045WJ989B	EMULSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ANHYDROUS CITRIC ACID	ANHYDROUS CITRIC ACID	XF417D3PSL	TABLET, CHEWABLE, EXTENDED RELEASE / ORAL		12 mg	Exact identifier — unii candidate 61 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL, METERED / TRANSDERMAL		50 mg	Exact identifier — unii candidate 18 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
A089682-001	HYDROCORTISONE	HYDROCORTISONE	2.5%	CREAM / TOPICAL			1988-03-10

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL		1988-03-10	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL		1988-03-10	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089682-001	HYDROCORTISONE	2.5%	CREAM / TOPICAL	AT	1988-03-10	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A089682-001	AT	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A089682-001	AT	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A089682-001	AT	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A089682-001	AT	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A089682-001	AT	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A089682-001	AT	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A089682-001	AT	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A089682-001	AT	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A089682-001	AT	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A089682-001	AT	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A089682-001	AT	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A089682-001	AT	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A089682-001	AT	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A089682-001	AT	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A089682-001	AT	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A089682-001	AT	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A089682-001	AT	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A089682-001	AT	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A089682-001	AT	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A089682-001	AT	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A089682-001	AT	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A089682-001	AT	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A089682-001	AT	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A089682-001	AT	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A089682-001	AT	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A089682-001	AT	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A089682-001	AT	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A089682-001	AT	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A089682-001	AT	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A089682-001	AT	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A089682-001	AT	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A089682-001	AT	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A089682-001	AT	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A089682-001	AT	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A089682-001	AT	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A089682-001	AT	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A089682-001	AT	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A089682-001	AT	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A089682-001	AT	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A089682-001	AT	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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
fa21d1bb-b3b7-4ff9-93b9-29adb6312fc9			a5f16c13-2a51-4541-bf9e-d80bc01a8dbd	2020-07-01	Adverse reactions	Exact identifier spl set id: a5f16c13-2a51-4541-bf9e-d80bc01a8dbd

Reported adverse events (FAERS/openFDA)#

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