FDA.reportPublic FDA data

CAREALL Hydrocortisone

Product NDC
51824-197
11-digit product format
518240197
Labeler code
51824
Product ID
51824-197_51273eb3-752d-b118-e063-6394a90ad0bf
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
New World Imports, Inc.
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-06-15
Substance
HYDROCORTISONE
Active strength
.01 g/g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
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
CAREALL Hydrocortisone
Brand name suffix
Maximum Strength
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE.01 g/g

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
5114cdba-96a1-c399-e063-6294a90aac12Available on FDA.report

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 47 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NUVALU ICE THERAPY MENTHOL PAIN RELIEVINGMENTHOLNINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO., LTD.4a24e813-6dbc-3fd1-e063-6294a90a4ff02026-01-01WarningsExact identifier
application number: M017
Lidozen PatchLIDOCAINE, MENTHOLVillage Pharma LLCd0ec7d25-ad58-46f2-b3b3-f13b4648b0b62026-01-01WarningsExact identifier
application number: M017
FEMININE PAIN RELIEFMENTHOL, UNSPECIFIED FORMBeYou Together Ltd9636b973-fe7e-481e-a6e9-8070347c08832025-12-31WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HCLFSA Store Inc.47434af6-0fdd-9615-e063-6394a90ab9e82025-12-31WarningsExact identifier
application number: M017
Winco Lidocaine Pain Patch 4% 5ctLIDOCAINE PAIN PATCH 4%WINCO FOODS, LLC47439162-fc34-f0d0-e063-6394a90a29ab2025-12-31WarningsExact identifier
application number: M017
Pain Relief PatchPAIN RELIEF PATCHQUEST USA CORP.1ad47834-4f8e-c692-e063-6294a90a7e772025-12-31WarningsExact identifier
application number: M017
DermagesicPRAMOXINE HCL, ZINC OXIDE, CALAMINELlorens Pharmaceutical International Divisionbbff6b53-29da-45c1-8ccd-3e9df7f250e02025-12-31WarningsExact identifier
application number: M017
Dologesic Roll-OnLIDOCAINE HCLLlorens Pharmaceutical International Division, Inc.81546810-85a8-45fe-b9e6-cdd02cc4c0802025-12-31WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub LavenderCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company47473b24-a3e3-2858-e063-6394a90a59202025-12-31WarningsExact identifier
application number: M017
Eucerin Itch Relief Intensive CalmingMENTHOLBeiersdorf Inca7a78af1-1f5a-684d-e053-2a95a90a6ae92025-12-31WarningsExact identifier
application number: M017
Eucerin Skin Calming Itch Relief TreatmentMENTHOLBeiersdorf Inc7e568311-1e6b-9b4b-e053-2991aa0a7b672025-12-31WarningsExact identifier
application number: M017
Steady FreddyLIDOCAINEMedical Symbiosis Pty Ltdcaa9eae9-7028-5185-e053-2a95a90ac5042025-12-31WarningsExact identifier
application number: M017
HYDROCORTISONEANTI-ITCH CREAMWater-Jel Technologies3d34ae31-265a-46bc-a52d-546ea5bb24b62025-12-31WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEWater-Jel Technologies, LLCef1a6100-7f78-1fdb-e053-2a95a90abf202025-12-31WarningsExact identifier
application number: M017
Kroger Pain Relief Lidocaine PatchLIDOCAINEKroger Companyf6407554-c9a7-24e2-e053-2a95a90aae022025-12-30WarningsExact identifier
application number: M017
Kroger Hot and Cold Medicated PatchMENTHOLKroger Company0331c1dd-fe30-421a-85a7-6c6886e7ab272025-12-30WarningsExact identifier
application number: M017
Menthol, CamphorMENTHOL, CAMPHORChemco Corporation472fb097-92e5-c230-e063-6294a90ab33a2025-12-30WarningsExact identifier
application number: M017
MENTHOLMENTHOLCHEMCO CORPORATIOM472fb99c-dcc2-d9a9-e063-6294a90a794c2025-12-30WarningsExact identifier
application number: M017
Nufabrx Elbow SleeveCAPSAICINNufabrx LLC473004cd-f7f9-3c68-e063-6294a90a5b8a2025-12-30WarningsExact identifier
application number: M017
Nufabrx Leg SleeveCAPSAICINNufabrx LLC473015ed-3e0f-6eae-e063-6294a90a4c742025-12-30WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
51824-197-025182401970272 TUBE in 1 CARTON (51824-197-02) / 28 g in 1 TUBE (51824-197-01) 72 tube2026-06-15NoNoCurrent
51824-197-03518240197033 TUBE in 1 CARTON (51824-197-03) / 28 g in 1 TUBE (51824-197-01) 3 tube2026-06-15NoNoCurrent
51824-197-04518240197044 TUBE in 1 CARTON (51824-197-04) / 28 g in 1 TUBE (51824-197-01) 4 tube2026-06-15NoNoCurrent