FDA.reportPublic FDA data

TrueLipids 1% Hydrocortisone Barrier Cream

Product NDC
61387-252
11-digit product format
613870252
Labeler code
61387
Product ID
61387-252_46012e53-986d-7eb7-e063-6294a90a56ac
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Claridei Laboratories
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-08-10
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
TrueLipids 1% Hydrocortisone Barrier Cream
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
037395dc-5b96-052e-e063-6394a90a26e4Available 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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
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
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
61387-252-01TrueLipids 1% Hydrocortisone Barrier Cream50 g in 1 TUBECREAM504

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
61387-252TRUELIPIDS 1% HYDROCORTISONE BARRIER CREAM (HYDROCORTISONE) CREAM [CLARIDEI LABORATORIES]2Current NDC, 1 package rows20241024_037395dc-5b96-052e-e063-6394a90a26e4.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 30 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CeraVe Developed with Dermatologists Eczema Relief MoisturizingCOLLOIDAL OATMEALL'Oreal USA Products Incc4dde987-fe4e-4f8e-8f3a-1bc12c9588ed2025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company446ddb19-4bdb-6827-e063-6394a90a6af82025-12-09WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Warm VanillaCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company45864832-51bb-4e24-e063-6294a90ab5542025-12-09WarningsExact identifier
application number: M016
AquaSootheAQUASOOTHEDynarex Corporation45878c3c-d05d-984c-e063-6294a90a46612025-12-09WarningsExact identifier
application number: M016
Soteri Skin Long-Term Eczema Relief CreamCOLLOIDAL OATMEALSoteri Skin, Inc41d752cb-3866-e840-e063-6394a90acc372025-12-09WarningsExact identifier
application number: M016
Earths Care EczemaOATMEALDLC Laboratories, Inc.f72e2adf-8930-458f-a6cc-9b240b2f5eba2025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sparkling GrapefruitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4575ba40-009c-26e0-e063-6394a90adee62025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Chai CinnamonCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9531-4db4-e063-6394a90a9fd32025-12-08WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin ProtectantCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybeb22d69-8a83-65dc-e053-2a95a90ad8122025-12-08WarningsExact identifier
application number: M016
Medicated Hemorrhoidal PadsWITCH HAZELCardinal Health0b49db40-7abc-4e62-b6da-4b9f5b0ae16d2025-12-05WarningsExact identifier
application number: M016
CVS Health MedicatedWITCH HAZELCVS Pharmacya74ab253-cafc-4f00-9b8f-e5c1e6e7f2212025-12-05WarningsExact identifier
application number: M016
Major Medi-PadsWITCH HAZELMajor Pharmaceuticalsd2a314a2-98ab-4ac0-9e90-1a8c1303958f2025-12-05WarningsExact identifier
application number: M016
Good Sense MedicatedWITCH HAZELGeiss, Destin & Dunn, Inc5f122db5-4391-4957-9c25-76834c356c4f2025-12-05WarningsExact identifier
application number: M016
Witch HazelMEDICATED HEMORRHOIDAL WIPESGiant Eaglecdd9d6b7-cbc9-2839-e053-2a95a90ada002025-12-05WarningsExact identifier
application number: M016
Cool ComfortORGANIC WITCH HAZELNaticura Incde14c19c-56b5-4727-9194-94e85425ca8a2025-12-05WarningsExact identifier
application number: M016
GOODSENSE Maximum Strength MedicatedWITCH HAZELGEISS, DESTIN & DUNN, INC5453a12b-e775-4101-bd3a-337857e9e1672025-12-05WarningsExact identifier
application number: M016
Medicated Multipurpose WipesWITCH HAZELQUEST USA CORP.0f28d5f9-b20a-ac6f-e063-6394a90ac2082025-12-05WarningsExact identifier
application number: M016
Gold Bond Medicated eczema reliefCOLLOIDAL OATMEALGold Bond Co LLCc292e443-7418-4679-b9b2-4e6d96c04c4c2025-12-05WarningsExact identifier
application number: M016
Prequel Skin Utility OintMULTI PURPOSE SKIN PROTECTANTThe Center Brands, LLC2bf0931e-245d-14a6-e063-6294a90a66812025-12-04WarningsExact identifier
application number: M016
Prequel Skin Utility Balm Multi-Purpose Skin ProtectantSKIN PROTECTANT BALMThe Center Brands, LLC57c0b71d-6099-415c-976d-b96d2f73e9d32025-12-04WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN037395dc-5b96-052e-e063-6394a90a26e44
106258hydrocortisone 10 MG/ML Topical CreamSCD037395dc-5b96-052e-e063-6394a90a26e44
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY037395dc-5b96-052e-e063-6394a90a26e44
106258hydrocortisone 1 % Topical CreamSY037395dc-5b96-052e-e063-6394a90a26e44
106258hydrocortisone 1 GM per 100 GM Topical CreamSY037395dc-5b96-052e-e063-6394a90a26e44

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
61387-252-016138702520150 g in 1 TUBE (61387-252-01) 50 g2023-08-10NoNoCurrent