TopCare

Manufacturer: Topco Associates LLC | Sun Pharma Canada Inc.
Effective date: 2025-07-15
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: full-release
Hydrated at: 2026-06-01 01:07:24

Label at a glance#

ProductTopCare Hydrocortisone Intensive Healing Formula

Active ingredientHYDROCORTISONE

Label structure11 sections

Indications and uses

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to: eczema psoriasis poison ivy, oak, sumac insect bites detergents jewelry cosmetics soaps seborrheic dermatitis temporarily relieves external anal and genital itching other uses of this product should only be under the advice and supervision of a doctor

Dosage and administration

for itching of skin irritation, inflammation, and rashes: adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily children under 2 years of age: ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and warm water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before...

Storage and handling

To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube store between 20° to 25°C (68° to 77°F) See carton or tube crimp for lot number and expiration date

Contacts and useful links#

PhoneLabel contact1-888-423-0139

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching associated with minor skin irritations, inflammation, and rashes due to:
- eczema
- psoriasis
- poison ivy, oak, sumac
- insect bites
- detergents
- jewelry
- cosmetics
- soaps
- seborrheic dermatitis
temporarily relieves external anal and genital itching
other uses of this product should only be under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

in the genital area if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes
do not use more than directed unless told to do so by a doctor
do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

condition worsens, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
rectal bleeding occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

for itching of skin irritation, inflammation, and rashes:
- adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily
- children under 2 years of age: ask a doctor
for external anal and genital itching, adults:
- when practical, clean the affected area with mild soap and warm water and rinse thoroughly
- gently dry by patting or blotting with toilet tissue or a soft cloth before applying
- apply to affected area not more than 3 to 4 times daily
- children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

To open: unscrew cap, pull tab to remove foil seal, and screw cap back onto tube
store between 20° to 25°C (68° to 77°F)
See carton or tube crimp for lot number and expiration date

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis, cetearyl alcohol/sodium lauryl sulfate/sodium cetearyl sulfate, chamomile (anthemis nobilis) oil, citric acid, corn (zea mays) oil, glycerin, glyceryl stearate, isopropyl palmitate, maltodextrin, methylparaben, mineral oil, paraffin, petrolatum, propylene glycol, propylparaben, purified water, stearyl alcohol, vitamin A (retinyl palmitate), vitamin D (cholecalciferol), vitamin E (tocopheryl acetate).

Questions?

OTC - QUESTIONS SECTION

Call 1-888-423-0139

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare
health _™

MAXIMUM STRENGTH

• OUR PHARMACISTS
RECOMMEND •

NDC 36800-099-02

Hydrocortisone 1% Cream

ANTIPRURITIC (ANTI-ITCH)

Intensive Healing Formula ^†

NET WT 1 OZ (28.4 g)

Principal Display Panel - 28.4 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	4
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	4
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	4
106258	hydrocortisone 1 % Topical Cream	SY	4
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
36800-099-02	TopCareHydrocortisone Intensive Healing Formula	28.4 g in 1 TUBE	CREAM	28.4		4
36800-099-02	TopCareHydrocortisone Intensive Healing Formula	1 in 1 CARTON	CREAM	1		4

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	1
chamomile flower oil	INACTIVE INGREDIENT	60F80Z61A9	1
cholecalciferol	INACTIVE INGREDIENT	1C6V77QF41	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	1
corn oil	INACTIVE INGREDIENT	8470G57WFM	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	1
isopropyl palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	1
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	1
sodium cetostearyl sulfate	INACTIVE INGREDIENT	7ZBS06BH4B	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	1
vitamin A palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	1
water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

TopCare Hydrocortisone Intensive Healing Formula
Hydrocortisone
CETOSTEARYL ALCOHOL
SODIUM LAURYL SULFATE
SODIUM CETOSTEARYL SULFATE
CHAMOMILE FLOWER OIL
CITRIC ACID MONOHYDRATE
CORN OIL
GLYCERIN
GLYCERYL MONOSTEARATE
ISOPROPYL PALMITATE
MALTODEXTRIN
METHYLPARABEN
MINERAL OIL
PARAFFIN
PETROLATUM
PROPYLENE GLYCOL
PROPYLPARABEN
WATER
STEARYL ALCOHOL
VITAMIN A PALMITATE
CHOLECALCIFEROL
.ALPHA.-TOCOPHEROL ACETATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
36800-099	36800-099-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	IACT
CHAMOMILE FLOWER OIL	60F80Z61A9	IACT
CITRIC ACID MONOHYDRATE	2968PHW8QP	IACT
CORN OIL	8470G57WFM	IACT
GLYCERIN	PDC6A3C0OX	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT
ISOPROPYL PALMITATE	8CRQ2TH63M	IACT
MALTODEXTRIN	7CVR7L4A2D	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
MINERAL OIL	T5L8T28FGP	IACT
PARAFFIN	I9O0E3H2ZE	IACT
PETROLATUM	4T6H12BN9U	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
WATER	059QF0KO0R	IACT
STEARYL ALCOHOL	2KR89I4H1Y	IACT
VITAMIN A PALMITATE	1D1K0N0VVC	IACT
CHOLECALCIFEROL	1C6V77QF41	IACT
.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	IACT
HYDROCORTISONE	WI4X0X7BPJ	ACTIB

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 2 · 66 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
sodium cetostearyl sulfate	SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	SUSPENSION / ORAL		6040 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
corn oil	CORN OIL	8470G57WFM	CREAM / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	CAPSULE / ORAL	2 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
sodium lauryl sulfate	SODIUM LAURYL SULFATE	368GB5141J	CREAM / TOPICAL		214 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
propylparaben	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL		6 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
paraffin	PARAFFIN	I9O0E3H2ZE	CREAM / TOPICAL		300 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	LOZENGE / ORAL		175 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
sodium cetostearyl sulfate	SODIUM CETOSTEARYL SULFATE	7ZBS06BH4B	CREAM / TOPICAL	1 %w/w		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
citric acid monohydrate	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL		4 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / TOPICAL		162000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	PASTE / ORAL		1050 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
mineral oil	MINERAL OIL	T5L8T28FGP	CREAM / TOPICAL		2772 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
isopropyl palmitate	ISOPROPYL PALMITATE	8CRQ2TH63M	CREAM / TOPICAL		112 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, CHEWABLE / ORAL	292 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
methylparaben	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL		3000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
corn oil	CORN OIL	8470G57WFM	CREAM / TOPICAL	NA		Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
petrolatum	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
glycerin	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL		1720 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
glyceryl monostearate	GLYCERYL MONOSTEARATE	230OU9XXE4	CREAM / TOPICAL		836 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	TABLET / ORAL	0.5 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	POWDER, FOR SUSPENSION / ORAL		8000 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
stearyl alcohol	STEARYL ALCOHOL	2KR89I4H1Y	CREAM / TOPICAL		162000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	NA		Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET / ORAL		320 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	FILM, SOLUBLE / ORAL		19 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, EXTENDED RELEASE / ORAL		3239 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
.alpha.-tocopherol acetate	.ALPHA.-TOCOPHEROL ACETATE	9E8X80D2L0	FILM / BUCCAL	0.09 mg		Exact identifier — unii candidate 6 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	GRANULE, FOR SUSPENSION / ORAL		952 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
propylene glycol	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL		76000 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
cetostearyl alcohol	CETOSTEARYL ALCOHOL	2DMT128M1S	CREAM / TOPICAL		1428 mg	Exact identifier — unii+route+dosage form 2 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	TABLET, COATED / ORAL	5.6 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
maltodextrin	MALTODEXTRIN	7CVR7L4A2D	CAPSULE / ORAL		200 mg	Exact identifier — unii candidate 30 equally ranked IID candidates

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
TopCare Hydrocortisone Intensive Healing Formula	HYDROCORTISONE	Topco Associates LLC	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	2025-07-15	Warnings	Exact identifier ndc (package): 36800-099-02 ndc (product): 36800-099 ndc11 (package): 36800009902 spl id: 39f905a7-c017-5474-e063-6394a90adf19 spl set id: 7daafc44-e2a4-4f1b-bfca-3309a8e9a920

Reported adverse events (FAERS/openFDA)#

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