TopCare

Product NDC: 36800-099
11-digit product format: 368000099
Labeler code: 36800
Product ID: 36800-099_39f905a7-c017-5474-e063-6394a90adf19
Type: HUMAN OTC DRUG
Nonproprietary name: Hydrocortisone
Dosage form: CREAM
Route: TOPICAL
Labeler: Topco Associates LLC
Application: M017
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 1995-08-23
Substance: HYDROCORTISONE
Active strength: 1 g/100g
Pharmacologic classes: Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: TopCare
Brand name suffix: Hydrocortisone Intensive Healing Formula
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
HYDROCORTISONE	1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
WI4X0X7BPJ	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
106258	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
7daafc44-e2a4-4f1b-bfca-3309a8e9a920	Available on FDA.report

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	DailyMed label	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
.alpha.-tocopherol acetate	INACTIVE INGREDIENT	9E8X80D2L0	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
cetostearyl alcohol	INACTIVE INGREDIENT	2DMT128M1S	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
chamomile flower oil	INACTIVE INGREDIENT	60F80Z61A9	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
cholecalciferol	INACTIVE INGREDIENT	1C6V77QF41	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
citric acid monohydrate	INACTIVE INGREDIENT	2968PHW8QP	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
corn oil	INACTIVE INGREDIENT	8470G57WFM	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
glycerin	INACTIVE INGREDIENT	PDC6A3C0OX	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
glyceryl monostearate	INACTIVE INGREDIENT	230OU9XXE4	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
isopropyl palmitate	INACTIVE INGREDIENT	8CRQ2TH63M	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
maltodextrin	INACTIVE INGREDIENT	7CVR7L4A2D	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
mineral oil	INACTIVE INGREDIENT	T5L8T28FGP	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
paraffin	INACTIVE INGREDIENT	I9O0E3H2ZE	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
petrolatum	INACTIVE INGREDIENT	4T6H12BN9U	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
propylene glycol	INACTIVE INGREDIENT	6DC9Q167V3	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
sodium cetostearyl sulfate	INACTIVE INGREDIENT	7ZBS06BH4B	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
sodium lauryl sulfate	INACTIVE INGREDIENT	368GB5141J	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
stearyl alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
vitamin A palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1
water	INACTIVE INGREDIENT	059QF0KO0R	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
36800-099	TOPCARE HYDROCORTISONE INTENSIVE HEALING FORMULA (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]	3	Current NDC, Legacy NDC, 2 package rows	20241105_7daafc44-e2a4-4f1b-bfca-3309a8e9a920.zip

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 148 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Point Relief Cold Spot Pain Relieving	MENTHOL	Fabrication Enterprises	391af69f-74aa-48cf-bc96-75e5c4e0e445	2023-11-05	Warnings	Exact identifier application number: M017
FEEL GOOD LABS NATURAL PAIN	MENTHOL	The Feel Good Lab	778b62a1-ebd3-4a30-8f76-6d6773b698c5	2023-11-05	Warnings	Exact identifier application number: M017
FEEL GOOD LABS SPORT RECOVERY	MENTHOL	The Feel Good Lab	103c5e33-42fb-41ac-957e-bb46d85e204c	2023-11-05	Warnings	Exact identifier application number: M017
INSTA RELIEF DM	LIDOCAINE HYDROCHLORIDE, MENTHOL	DM LAB CORP	6ef66fb9-9f49-409d-9503-175c7555ee9e	2023-11-05	Warnings	Exact identifier application number: M017
DR. MIKES Ponos Pain Relief Cream Roll-On	HISTAMINE DIHYDROCHLORIDE, MENTHOL	Dr. Mike's Vitamins, LLC	fcc45464-f1fe-4244-95a7-9b4288b0ce45	2023-11-05	Warnings	Exact identifier application number: M017
AcuPlus Pain Relief	MENTHOL	Innovations for Wellness, LLC	7f222a4f-85a8-4f3d-aa97-5c695d4da37f	2023-11-05	Warnings	Exact identifier application number: M017
Ana Cool Rapid Soothing Cooling Formula	HYDROCORTISONE	Ana-Cool, LLC	64b80cc2-e2d8-4535-aaf8-c031f4159cd1	2023-11-05	Warnings	Exact identifier application number: M017
FEEL GOOD LABS SPORT RECOVERY	MENTHOL	THE FEEL GOOD LAB, LLC	19b08cbf-5f43-4f07-8f4d-8cddb1492ab8	2023-11-05	Warnings	Exact identifier application number: M017
PlayMakar Roll On Cool Pain Relief	MENTHOL	PlayMakar Inc.	a12c16e7-561f-45a7-93c6-34d693ffdc7c	2023-11-05	Warnings	Exact identifier application number: M017
AcuPlus Advanced Therapy for Pain and Recovery	MENTHOL	INNOVATIONS FOR WELLNESS, LLC	840cfd15-4ea1-49bf-8c4f-86c12461d860	2023-11-05	Warnings	Exact identifier application number: M017
SCLERA CARE Topical Anesthetic Gel	LIDOCAINE HYDROCHLORIDE	ScleraCare, LLC	488ace02-fc0b-4d13-ab89-0e1640e915e5	2023-11-05	Warnings	Exact identifier application number: M017
IRELIEV ROLL ON COOL PAIN RELIEF	MENTHOL	Excel Health, Inc	dab94995-7393-4d9c-b295-72611a90919b	2023-11-05	Warnings	Exact identifier application number: M017
URIFLEX Fast Acting Analgesic Pain Relief	MENTHOL	Rejuvica LLC	fb78f705-b838-461d-b42c-8c98d3ca5d09	2023-11-05	Warnings	Exact identifier application number: M017
365 Medicated Lip Balm	MEDICATED LIP BALM	Whole Foods Market, Inc.	48309a7d-d2da-483c-8bf8-f59d9ad0bb73	2023-11-03	Warnings	Exact identifier application number: M017
COOL BREEZE Pain Relief	MENTHOL	COOL BREEZE US LLC	14dcf4ee-6778-49d4-8601-9205737432ea	2023-11-01	Warnings	Exact identifier application number: M017
Lidozen	LIDOCAINE HYDROCHLORIDE, MENTHOL	Proficient Rx LP	1ebb45e5-4541-4c95-abe1-661ef763a610	2023-11-01	Warnings	Exact identifier application number: M017
Walgreens Pain Relieving Cream	LIDOCAINE 4%	Walgreens	ce1b55ed-f5c5-ea8b-e053-2a95a90acd40	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens pain relieving	LIDOCAINE 4%	Walgreens	ce2b9e57-749d-715c-e053-2995a90aaf8d	2023-10-31	Warnings	Exact identifier application number: M017
Walgreens Cool n heat	LIDOCAINE 4% MENTHOL 1%	Walgreens	ce168ab7-ec4a-daea-e053-2995a90af829	2023-10-31	Warnings	Exact identifier application number: M017
Methyl Salicylate 40 Percent	METHYL SALICYLATE	Alexso, Inc	53407aab-094c-4393-a2b9-54fd85321e3e	2023-10-31	Warnings	Exact identifier application number: M017

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
WI4X0X7BPJ	HYDROCORTISONE	50-23-7	HYDROCORTISONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	4
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	4
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	4
106258	hydrocortisone 1 % Topical Cream	SY	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	4
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	7daafc44-e2a4-4f1b-bfca-3309a8e9a920	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
36800-099-02	36800009902	1 TUBE in 1 CARTON (36800-099-02) / 28.4 g in 1 TUBE	1 tube	1995-08-23	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
TopCare ® Hydrocortisone Intensive Healing Formula	Topco Associates LLC \| Sun Pharma Canada Inc.	2025-07-15	HUMAN OTC DRUG LABEL	4