FDA.reportPublic FDA data

Skin Relief Cream

Product NDC
68062-2266
11-digit product format
680622266
Labeler code
68062
Product ID
68062-2266_48df0cf4-f11d-5105-e063-6394a90a4695
Type
HUMAN OTC DRUG
Nonproprietary name
hydrocortisone
Dosage form
LOTION
Route
TOPICAL
Labeler
Spa de Soleil
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-11-19
Substance
HYDROCORTISONE
Active strength
.45 mg/45mL
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 18 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCCodeStatusSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductIInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage68062-2266-1IInactivated by FDAd630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductIInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage68062-2266-1IInactivated by FDAf5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproductIInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage68062-2266-1IInactivated by FDA2ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproductIInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage68062-2266-1IInactivated by FDAa1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductIInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage68062-2266-1IInactivated by FDAcfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductIInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage68062-2266-1IInactivated by FDAcdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproductUExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage68062-2266-1UExcluded because listing certification expired302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproductUExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage68062-2266-1UExcluded because listing certification expireded331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproductUExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage68062-2266-1UExcluded because listing certification expired0efc9e666f02…f202fb6c5f17…

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
Skin Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE.45 mg/45mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
0a90b77a-4be4-71c5-e063-6294a90a8e41Available 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68062-2266-12026-01-21C16284748780-12cef2736-ac86-d83d-e063-dadaa90ab31fSkin Relief Cream
68062-2266-12025-01-30C16284748780-12cef2736-ac86-d83d-e063-dadaa90ab31fSkin Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68062-2266-1Skin Relief Cream30 mL in 1 TUBELOTION302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68062-2266SKIN RELIEF CREAM (HYDROCORTISONE) LOTION [SPA DE SOLEIL]1Current NDC, 1 package rows20231121_0a90b77a-4be4-71c5-e063-6294a90a8e41.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 14 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Sweet Valetine Berry Much Besties, Mint To Be, Cherish Me CherryLIP BALM SKIN PROTECTANTSuave Brands Company47a2487d-b2e5-7195-e063-6394a90ae4812026-03-30WarningsExact identifier
application number: M016
ChapStick Classic CherrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC4512b5a0-ce1f-c53e-e063-6294a90a56b62026-03-30WarningsExact identifier
application number: M016
ChapStick Classic StrawberrySKIN PROTECTANT LIP BALMSuave Brands Co., LLC42770fff-d70a-d9d1-e063-6294a90aa98d2026-03-30WarningsExact identifier
application number: M016
Aveeno Skin Relief HealingGLYCERINKenvue Brands LLC345fdde5-700b-7103-e063-6394a90a0e3e2026-03-27WarningsExact identifier
application number: M016
Critic Aid ClearPETROLATUMColoplast Corp0b6da97e-519b-4579-9895-f4ede5c48b472026-03-27WarningsExact identifier
application number: M016
Baza ProtectZINC OXIDE AND DIMETHICONEColoplast Corp256dfcfc-a91c-49b0-9439-452586a0880e2026-03-27WarningsExact identifier
application number: M016
Sween 24DIMETHICONEColoplast Corpa623c8d7-8db0-410a-9980-02ac02f7b6ea2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and Protect Odor ControlDIMETHICONEColoplast Corpca5fa4ae-c18d-4457-b520-4a9318ea821f2026-03-27WarningsExact identifier
application number: M016
Baza Cleanse and ProtectDIMETHICONEColoplast Corp82eff041-0c9d-4261-a6b6-5a041a6600742026-03-27WarningsExact identifier
application number: M016
Baza ClearPETROLATUMColoplast Corp69d9f456-1a35-4146-8366-c0285648a1722026-03-27WarningsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMTopco Associates LLC5126fdf6-5df5-474b-bc0d-3a82dea61abb2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMAmazon.com Services LLCcdf1bd12-ac59-4f06-be0f-ef6eb3caeeff2026-03-26Warnings, Adverse reactionsExact identifier
application number: M016
Dynashield with DimethiconeZINC OXIDEDynarex Corporationb5dcf9e8-4689-4a08-ae73-3a859b4cbffe2026-03-26WarningsExact identifier
application number: M016
Eczema Relief CreamCOLLOIDAL OATMEALLavior Pharma Incbdd2fc9f-2718-1d88-e053-2995a90a86822026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f2dec8-7ffc-fc3e-e063-6294a90a76ff2026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f33001-7fec-682e-e063-6394a90a94282026-03-26WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC36f3b300-f32f-8881-e063-6394a90a1a2a2026-03-26WarningsExact identifier
application number: M016
White PetrolatumPETROLATUMDynarex Corporation81f5092d-0632-bf47-e053-2991aa0ac5632026-03-25WarningsExact identifier
application number: M016
MYEVERESTRIOL CREAMHubei Redrui Building Materials Co., Ltd.3ed85485-a441-4c05-e063-6394a90afef52026-03-25WarningsExact identifier
application number: M016
Softlips Peppermint SwirlDIMETHICONEThe Mentholatum Company4dbea50e-d82d-c702-e063-6394a90ac6e42026-03-24WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68062-2266-16806222660130 mL in 1 TUBE (68062-2266-1) 30 ml2023-11-19NoNoCurrent