FDA.reportPublic FDA data

Hydrocortisone Cream 1%

Product NDC
58228-6245
11-digit product format
582286245
Labeler code
58228
Product ID
58228-6245_46017470-c3c9-f7c5-e063-6294a90aef80
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Cream 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
Front Line Safety
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-01-26
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
Hydrocortisone Cream 1%
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
0f4ede34-7e70-789e-e063-6394a90a72a4Available 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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58228-6245-1Hydrocortisone Cream 1%25 in 1 BOXCREAM253
58228-6245-1Hydrocortisone Cream 1%1800 in 1 CASECREAM18003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-6245HYDROCORTISONE CREAM 1% CREAM [FRONT LINE SAFETY]2Current NDC, 2 package rows20241127_0f4ede34-7e70-789e-e063-6394a90a72a4.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 4 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermoia Psoriasis Treatment Salicylic AcidSALICYLIC ACIDTreasurewise LLCfec62bf1-7423-4806-9ac9-1254d7eb62da2026-05-27WarningsExact identifier
application number: M032
5% Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.5278c9c2-4bce-fed4-e063-6394a90a7f332026-05-23WarningsExact identifier
application number: M032
Minoxidil Hair Regrowth TreatmentMINOXIDILShenzhen Earth Surface Trading Co., Ltd.527902b1-2018-4546-e063-6394a90a70522026-05-23WarningsExact identifier
application number: M032
VeraRoot Minoxidil Topical SolutionVERAROOT MINOXIDIL TOPICAL SOLUTIONShenzhen Xinxin Yunhai Technology Co., Ltd.52794d53-43ba-98ea-e063-6394a90a80a92026-05-23WarningsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCLOreal USA Products Inc521c263e-d29c-2564-e063-6394a90a2e1d2026-05-18WarningsExact identifier
application number: M032
Matrix Biolage Scalp Sync AntidandruffPYRITHIONE ZINCL'Oreal USA Products Incea6fb9ff-8895-4754-9fd7-d24c235f01322026-05-15WarningsExact identifier
application number: M032
Simply Clean DandruffPYRITHIONE ZINCAldi, Inc6db037d4-c781-4cee-a4d5-52a93eccd55f2026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
2 in 1 DandruffPYRITHIONE ZINCAldi, Incb27d1453-d825-43ac-8a44-d7a5015ab9772026-05-13Warnings, Adverse reactionsExact identifier
application number: M032
CeraVe Anti-Dandruff Hydrating ConditionerPYRITHIONE ZINCL'Oreal USA Products Incd6a704df-edd8-4960-a088-246519e2aecf2026-05-12WarningsExact identifier
application number: M032
Kopa Haiku Seborrheic Dermatitis Face CreamSALICYLIC ACID 0.5% AND ZINC PYRITHIONE 0.25%Trovina Co. Ltd483450d2-e38b-56ec-e063-6394a90acb5b2026-05-10WarningsExact identifier
application number: M032
Mens SportPYRITHIONE ZINCApollo Health and Beauty Care1d1203ea-9994-31bb-e063-6394a90a9ec82026-05-08WarningsExact identifier
application number: M032
Classic CleanSHAMPOOApollo Health and Beauty Carefa684d69-771a-d3d4-e053-6294a90a13442026-05-08WarningsExact identifier
application number: M032
CVS GoldSELENIUM SULFIDEApollo Health and Beauty Care1d12ca6a-2734-0534-e063-6294a90a27062026-05-08WarningsExact identifier
application number: M032
Everyday CleanPYRITHIONE ZINCApollo Health and Beauty Care0a4ab6fa-bf74-fe6e-e063-6394a90aa6fc2026-05-08WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Total Scalp CarePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company5126db42-4fd3-319e-e063-6394a90aab3f2026-05-06WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDCISNE GROUP LLC512abbb6-ea6a-70b1-e063-6294a90a2a7c2026-05-06WarningsExact identifier
application number: M032
WalgreensSALICYLIC ACIDWalgreensec1a09dc-7fb6-6d89-e053-2a95a90a48412026-05-05WarningsExact identifier
application number: M032
Follence MedicatedSALICYLIC ACIDGuangzhou Pallas Cosmetics Co.,Ltd.51178cb9-f83f-2459-e063-6394a90a3f1e2026-05-05WarningsExact identifier
application number: M032
Recuren Plus Balanced ScalpSALICYLIC ACIDREGENEREN PLUS LTD50c27b0f-9bf5-de9c-e063-6394a90af41a2026-05-04WarningsExact identifier
application number: M032
Mielle Lavender and Lychee Scalp MoisturizingPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company510212e9-1d12-3a0a-e063-6294a90a1d782026-05-04WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN0f4ede34-7e70-789e-e063-6394a90a72a43
106258hydrocortisone 10 MG/ML Topical CreamSCD0f4ede34-7e70-789e-e063-6394a90a72a43
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY0f4ede34-7e70-789e-e063-6394a90a72a43
106258hydrocortisone 1 % Topical CreamSY0f4ede34-7e70-789e-e063-6394a90a72a43
106258hydrocortisone 1 GM per 100 GM Topical CreamSY0f4ede34-7e70-789e-e063-6394a90a72a43

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-6245-1582286245011800 BOX in 1 CASE (58228-6245-1) / 25 PACKET in 1 BOX / .9 g in 1 PACKET1800 box2024-01-26NoNoCurrent