FDA.reportPublic FDA data

TopCare

Product NDC
36800-051
11-digit product format
368000051
Labeler code
36800
Product ID
36800-051_399473ae-9191-1ef1-e063-6294a90a9219
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
1989-10-03
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 Plus 12 Moisturizers
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c40e8e1d-d6d7-4880-99d3-011b97a5e4f3Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-051-06TopCareHydrocortisone Plus 12 Moisturizers1 in 1 CARTONCREAM14
36800-051-06TopCareHydrocortisone Plus 12 Moisturizers42.6 g in 1 TUBECREAM42.64
36800-051-18TopCareHydrocortisone Plus 12 Moisturizers1 in 1 CARTONCREAM14
36800-051-18TopCareHydrocortisone Plus 12 Moisturizers28.4 g in 1 TUBECREAM28.44

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1STOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
chamomile flower oilINACTIVE INGREDIENT60F80Z61A9TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
cholecalciferolINACTIVE INGREDIENT1C6V77QF41TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
corn oilINACTIVE INGREDIENT8470G57WFMTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
glyceryl monostearateINACTIVE INGREDIENT230OU9XXE4TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
isopropyl palmitateINACTIVE INGREDIENT8CRQ2TH63MTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
maltodextrinINACTIVE INGREDIENT7CVR7L4A2DTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
paraffinINACTIVE INGREDIENTI9O0E3H2ZETOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
propylene glycolINACTIVE INGREDIENT6DC9Q167V3TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
sodium cetostearyl sulfateINACTIVE INGREDIENT7ZBS06BH4BTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
sodium lauryl sulfateINACTIVE INGREDIENT368GB5141JTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
Vitamin A palmitateINACTIVE INGREDIENT1D1K0N0VVCTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1
waterINACTIVE INGREDIENT059QF0KO0RTOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-051TOPCARE HYDROCORTISONE PLUS 12 MOISTURIZERS (HYDROCORTISONE) CREAM [TOPCO ASSOCIATES LLC]3Current NDC, Legacy NDC, 4 package rows20241107_c40e8e1d-d6d7-4880-99d3-011b97a5e4f3.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 80 of 151 · 3,010 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ELAIMEI Numbing CreamLIDOCAINE 4%Shenzhen Shandian Jingling Technology Co., Ltd.37ac13b2-ca55-0e28-e063-6294a90a000e2025-08-19WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
application number: M017
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
application number: M017
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
application number: M017
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
application number: M017
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
application number: M017
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017
Lidocaine 3%LIDOCAINE HCL 3%PureTek Corporation3bc94d52-fe52-9fd6-e063-6294a90a43402025-08-12WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.d8c42c8d-6ce0-43bf-b165-41979f3d8f792025-08-12WarningsExact identifier
application number: M017
Careland X-large Lidocaine 4 Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6867506-4a46-47b1-b5b6-bfedb59dfde62025-08-11WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLSaje Natural Business Inc.3c194b8f-cfa5-11e3-e063-6394a90a92de2025-08-11WarningsExact identifier
application number: M017
Thera Plus Extra Strength Muscle Rub Topical AnalgesicMENTHOLFOURSTAR GROUP USA, INC.8a3b6adf-afbb-4d77-a19b-a6514ebd3b502025-08-11WarningsExact identifier
application number: M017
EARTHS CARE ARTHRITISCAPSAICINDLC Laboratories, Inc.9460674b-057e-40b9-a0f9-ca3d92068d4f2025-08-11WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNc40e8e1d-d6d7-4880-99d3-011b97a5e4f34
106258hydrocortisone 10 MG/ML Topical CreamSCDc40e8e1d-d6d7-4880-99d3-011b97a5e4f34
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYc40e8e1d-d6d7-4880-99d3-011b97a5e4f34
106258hydrocortisone 1 % Topical CreamSYc40e8e1d-d6d7-4880-99d3-011b97a5e4f34
106258hydrocortisone 1 GM per 100 GM Topical CreamSYc40e8e1d-d6d7-4880-99d3-011b97a5e4f34

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
36800-051-06368000051061 TUBE in 1 CARTON (36800-051-06) / 42.6 g in 1 TUBE1 tube1989-10-030000-00-00NoNoCurrent
36800-051-18368000051181 TUBE in 1 CARTON (36800-051-18) / 28.4 g in 1 TUBE1 tube1989-10-030000-00-00NoNoCurrent