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 48 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nufabrx Arm SleeveCAPSAICINNufabrx LLC472ef560-1ed6-c912-e063-6394a90aaa1c2025-12-30WarningsExact identifier
application number: M017
Nufabrx Shin SleeveCAPSAICINNufabrx LLC4730bf64-ea0c-ca8d-e063-6394a90af5422025-12-30WarningsExact identifier
application number: M017
Nufabrx Ankle SleeveCAPSAICINNufabrx LLC4730d164-9027-fff2-e063-6394a90a42802025-12-30WarningsExact identifier
application number: M017
Nufabrx Knee SleeveCAPSAICINNufabrx LLC473098ca-02f1-c287-e063-6394a90a37e12025-12-30WarningsExact identifier
application number: M017
PAIN RELIEF PATCHESLIDOCAINELiberty Procurement, In2d381c48-402f-4e46-81b2-41a184139a612025-12-30WarningsExact identifier
application number: M017
Thera Care Pain Relief Menthol PatchsMENTHOLVeridian Healthcare1faa1d4f-b7fb-4f36-aef1-2fedde114b8e2025-12-30WarningsExact identifier
application number: M017
Lidocaine Pain ReliefLIDOCAINE PAIN RELIEFAllegiant Health7f715144-f0c8-48fc-a22d-eac85759c66a2025-12-30WarningsExact identifier
application number: M017
ZIKS ARTHRITIS PAIN RELIEFZIKS ARTHRITIS PAIN RELIEFNnodum Pharmaceuticals5dd4fefc-b70a-4850-819c-1cca6f28aa972025-12-29WarningsExact identifier
application number: M017
Ted and Gregs Pain Rub with Resveratrol Topical AnalgesicMETHYL SALICYLATETed and Greg's Inc.c699438d-595d-4711-801b-51e960aa36682025-12-29WarningsExact identifier
application number: M017
Frankincense and Myrrh Arthritis Pain Combo PackMENTHOLWISE CONSUMER PRODUCTS CO.47199677-e04c-768b-e063-6294a90a35242025-12-29WarningsExact identifier
application number: M017
Witch HazelWITCH HAZELCVS HEALTHb8b79e8d-9c84-1700-e053-2995a90af5bd2025-12-29WarningsExact identifier
application number: M017
WALGREENS BURNLIDOCAINE HYDROCHLORIDEWALGREENSb61e6d73-4f41-ef50-e053-2a95a90a0fc62025-12-29WarningsExact identifier
application number: M017
CVS cold and HotMENTHOL 16%CVSd1676df9-530f-1664-e053-2995a90a5b642025-12-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEAKRON PHARMA INCfa956b6a-1712-4f7a-9490-11866dcd17c82025-12-29WarningsExact identifier
application number: M017
Frankincense and Myrrh Nerve Combo PackMENTHOLWise Consumer Products471d815c-1c34-e0f8-e063-6294a90aca782025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d3c8d-7b70-e973-e053-2991aa0aaa782025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781dfd66-f006-a2d7-e053-2991aa0a170c2025-12-29WarningsExact identifier
application number: M017
Pain ReleaseMENTHOLNatures Formulae Health Products Ltd.781d53cf-b3df-3e2b-e053-2a91aa0a7dcd2025-12-29WarningsExact identifier
application number: M017
Trauma LessMENTHOLNatures Formulae Health Products Ltd.781e94d5-1d34-7202-e053-2991aa0ae7682025-12-29WarningsExact identifier
application number: M017
Quality Choice Cold Therapy GelMENTHOLChain Drug Marketing Association, Inc.f9c659cd-e7fa-ac2d-e053-6294a90a25732025-12-29WarningsExact 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