FDA.reportPublic FDA data

Hydrocortisone 1%

Product NDC
58228-2045
11-digit product format
582282045
Labeler code
58228
Product ID
58228-2045_46013b99-8359-912c-e063-6294a90a1050
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone 1%
Dosage form
CREAM
Route
TOPICAL
Labeler
ProStat First Aid LLC
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-04-10
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
Hydrocortisone 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
f707bda4-074a-6406-e053-6394a90a7ae1Available 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
58228-2045-1Hydrocortisone 1%0.9 g in 1 PACKETCREAM0.93
58228-2045-1Hydrocortisone 1%25 in 1 BOXCREAM253
58228-2045-2Hydrocortisone 1%1800 in 1 CASECREAM18003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
58228-2045HYDROCORTISONE 1% CREAM [PROSTAT FIRST AID LLC]2Current NDC, 3 package rows20241127_f707bda4-074a-6406-e053-6394a90a7ae1.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 21 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Neutrogena Scalp Therapy Anti-Dandruff Extra StrengthSALICYLIC ACIDKenvue Brands LLCca49fd70-f0d3-3375-e053-2a95a90af8352025-03-10WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Coastal TidePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company20d3208c-d22b-84f1-e063-6394a90ab6102025-03-06WarningsExact identifier
application number: M032
Head and Shoulders Supreme Nourish and Smooth ConditionerPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company86abb2ee-6b35-32eb-e053-2a91aa0a8bc62025-03-03WarningsExact identifier
application number: M032
Cantu Guava Ginger Anti DandruffSALICYLIC ACIDPDC Brandsd43a540b-bea5-2055-e053-2995a90a25fb2025-03-03WarningsExact identifier
application number: M032
Head and Shoulders 2in1 MenTimber Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2d7ff3d8-d142-9537-e063-6294a90ab02c2025-02-06WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Clinical Strength Dry Scalp RescueSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2d041983-5750-e0f1-e063-6394a90a5b9e2025-01-31WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Vanilla and AmberPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cf441e0-3ddd-0f9e-e063-6394a90a092c2025-01-30WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Full and ThickPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3f0664-a9e7-6b63-e053-2991aa0a4b0a2025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Dry Scalp Care Dual PackPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cdb1e94-3923-84f7-e063-6394a90a07d52025-01-29WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Itchy Scalp ReliefPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company2cc7724c-a1f1-a42d-e063-6394a90a83cf2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders 2in1 Men Advanced Series Swagger Old SpicePYRITHIONE ZINCThe Procter & Gamble Manufacturing Company7d3cca83-f99e-2c30-e053-2991aa0a4c9d2025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Clinical Strength Advanced Oil ControlSELENIUM SULFIDEThe Procter & Gamble Manufacturing Company2ccaceed-9928-ef05-e063-6394a90a65112025-01-28WarningsExact identifier
application number: M032
Head and Shoulders Bare Minimal Ingredients Soothing HydrationPYRITHIONE ZINCThe Procter & Gamble Manufacturing Company003d1723-1fd9-ef2b-e063-6294a90aafda2025-01-28WarningsExact identifier
application number: M032
QC Anti Dandruff T PlusCOAL TARGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c7630ab-b7fa-462c-e063-6394a90a30bb2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff 2 in 1PYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c762c86-ba7a-1976-e063-6394a90a49f22025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c764242-df65-7383-e063-6394a90a34b02025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCCHAIN DRUG MARKETING ASSOCIATION, INC.2c767d79-6ffe-ebaa-e063-6394a90a39d12025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Everyday CleanPYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd2c77edae-be2b-3a37-e063-6294a90a001d2025-01-24WarningsExact identifier
application number: M032
Quality Choice Dandruff Dry Scalp CarePYRITHIONE ZINCGuangzhou Danting Bath&Body Care Industry Co. Ltd.2c77e4b6-5a65-c7ea-e063-6394a90a6abb2025-01-24WarningsExact identifier
application number: M032
Zincon Medicated Anti-DandruffPYRITHIONE ZINCNeoteric Cosmetics, Inc.2c26bd1e-35d4-f1a2-e063-6294a90af5762025-01-23WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNf707bda4-074a-6406-e053-6394a90a7ae13
106258hydrocortisone 10 MG/ML Topical CreamSCDf707bda4-074a-6406-e053-6394a90a7ae13
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYf707bda4-074a-6406-e053-6394a90a7ae13
106258hydrocortisone 1 % Topical CreamSYf707bda4-074a-6406-e053-6394a90a7ae13
106258hydrocortisone 1 GM per 100 GM Topical CreamSYf707bda4-074a-6406-e053-6394a90a7ae13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-2045-1582282045010.9 g in 1 PACKET0.9 gHistorical
58228-2045-2582282045021800 BOX in 1 CASE (58228-2045-2) / 25 PACKET in 1 BOX (58228-2045-1) / .9 g in 1 PACKET1800 box2023-04-10NoNoCurrent