Hydrocortisone 1%

Product NDC
58228-7090
11-digit product format
582287090
Labeler code
58228
Product ID
58228-7090_5dbbcafc-0c1b-5322-e063-6394a90a982e
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
ProStat First Aid
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-01-13
Substance
HYDROCORTISONE
Active strength
1 g/100g
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
Hydrocortisone 1%
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

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 35 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
burnreliefLIDOCAINE HCLPublix Super Markets, Inc.9660f5e1-d39e-4f86-bf96-dff0f3bb729d2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Aloe Vera GelLIDOCAINE HCL, MENTHOLPublix Super Markets, Inc.fe442f1e-7045-481a-a501-d629bf568dfb2026-02-05Warnings, Adverse reactionsExact identifier
application number: M017
Care Lix Pain ReliefSALICYLIC ACIDACQUIRED B SCALE LLC65dffffd-ede1-45e2-aa91-bdd5df2df6a62026-02-05WarningsExact identifier
application number: M017
2.5% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.8075ba60-772c-4d1a-8584-722bb3e539be2026-02-05WarningsExact identifier
application number: M017
4% Menthol PAIN RELIEFMENTHOLNantong Health & Beyond Hygienic Products Inc.51ce716e-b9f3-4e64-8c8e-17520d40f1922026-02-05WarningsExact identifier
application number: M017
2.0% LIDOCAINE BURNLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.2b58058a-f350-4029-b039-117caf1c03732026-02-05WarningsExact identifier
application number: M017
4% MENTHOL COLD THERAPYMENTHOLNantong Health & Beyond Hygienic Products Inc.7acc7282-ef4f-41ec-b51d-a88dfed79bd72026-02-05WarningsExact identifier
application number: M017
Cooling GelPAIN RELIEF COOLING GELNeilMed Pharmaceuticals Inc.49fb637b-ecc5-1f9b-e063-6294a90ab41a2026-02-04WarningsExact identifier
application number: M017
Medicaine Sting and BiteBENZOCAINEDynarex Corporationb721607e-e36b-4691-a824-c8f520bd63862026-02-04WarningsExact identifier
application number: M017
HEATING PAIN RELIEFMETHYL SALICYLATE, MENTHOLCHEMCO CORPORATION4a05f02e-e882-2cb2-e063-6394a90ad3282026-02-04WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORCHEMCO CORPORATION4a065965-43bd-e0e3-e063-6294a90ad76a2026-02-04WarningsExact identifier
application number: M017
Menthol plus Camphor Pain ReliefMENTHOL, CAMPHORVeridian Healthcare4a0969d3-1f06-3ba7-e063-6294a90a86272026-02-04WarningsExact identifier
application number: M017
Relief FlexMENTHOLBeone Co., Ltd.49e6f0ef-78fb-26fe-e063-6294a90a66552026-02-03WarningsExact identifier
application number: M017
NATURULZ ULTIMATE HEALINGCAPSAICINI SHAY COSMETICS INC436eac74-d07f-d718-e063-6394a90a86602026-02-03WarningsExact identifier
application number: M017
TheraCare Muscle and Join Pain Relieving CreamMENTHOL, METHYL SALICYLATEVeridian Healthcare18f9829e-c5f9-4253-e063-6394a90a70c62026-02-03WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONECVS PHARMACY, INC8b8cdb26-8e8f-4e95-9d83-d685c90afe012026-02-02WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEEagle Indo Pharma, PT888f88fc-dcaf-93e5-e053-2a95a90a20e12026-02-02WarningsExact identifier
application number: M017
Wang Prom Green Balm by Wang PromWANG PROM WANG PROM GREEN BALM BY VENTURE GO LLCAMBIENCE FAMILY INC4a063898-16a4-695a-e063-6394a90adb932026-02-02WarningsExact identifier
application number: M017
Numbsure LIDOCAINELIDOCAINE 4%Hambli Limited43a65a12-ef2a-4608-e063-6394a90a82ea2026-01-31WarningsExact identifier
application number: M017
Collajoint Lidocaine Pain Relief Gel PatchLIDOCAINE PAIN RELIEF GEL PATCHHenan Enokon Medical Instrument Co., Ltd.44e27e7f-992f-d194-e063-6294a90a94e42026-01-31WarningsExact identifier
application number: M017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
58228-7090-15822870900125 PACKET in 1 BOX (58228-7090-1) / .9 g in 1 PACKET25 packet2026-01-13NoNoCurrent