FDA.reportPublic FDA data

Hydrocortisone

Product NDC
0404-0166
11-digit product format
004040166
Labeler code
0404
Product ID
0404-0166_5d41f237-8bd9-334d-e063-6294a90a8da3
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Henry Schein
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2022-11-07
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
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

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
0404-0166-502024-01-31C16284748780-11030e365-0475-111a-e063-dadaa90a10e2570-3124 Hydrocortisone Cream 1% NDC 0404-0166-50
0404-0166-502024-01-31C16284748780-11030e365-0475-111a-e063-dadaa90a10e2570-3124 Hydrocortisone Cream 1% NDC 0404-0166-50

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0404-0166-50Hydrocortisone1 in 1 BOXCREAM14
0404-0166-50Hydrocortisone72 in 1 CASECREAM724

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0404-0166HYDROCORTISONE CREAM [HENRY SCHEIN]3Current NDC, Legacy NDC, 2 package rows20241129_eb031535-d17e-9d5e-e053-2a95a90ad3e0.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 113 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HealthWise Medicated Foot PowderMENTHOLVeridian Healthcare2916a0c3-2d66-d079-e063-6394a90acd6b2024-12-12WarningsExact identifier
application number: M017
Ease Your PainMENTHOLProximity Capital Partners LLC dba Asutra83366ae1-e1d9-2a30-e053-2a91aa0a1cc42024-12-12WarningsExact identifier
application number: M017
Natural Seal Itch Relief for KidsLIDOCAINEKericure Inc.31cc0c95-5864-4737-b085-8f58e00f4f052024-12-12WarningsExact identifier
application number: M017
Vagisil Anti-Itch Creme Maximum Strength Sensitive Skin FormulaHYDROCORTISONE ACETATECombe Incorporated9b69fa24-02dd-43e4-a81f-9a37968d70992024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Medicated Creme Maximum StrengthBENZOCAINE AND RESORCINOLCombe Incorporatedbb73ebd7-ceb0-4b54-9e8f-77486d9037fb2024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Creme Regular StrengthBENZOCAINE AND RESORCINOLCombe Incorporateddd303ff8-0deb-4292-bfd8-5bda91f86d512024-12-12WarningsExact identifier
application number: M017
VAGISIL Anti-Itch Medicated Wipes Maximum StrengthPRAMOXINE HYDROCHLORIDECombe Incorporatedb848f53d-8aea-4efe-aa2c-009d5121fc332024-12-12WarningsExact identifier
application number: M017
Walgreens Cool and HeatMENTHOL 16%Walgreensce1585f4-ca65-8d0c-e053-2995a90a8e892024-12-11WarningsExact identifier
application number: M017
Walgreens Cool n HeatLIDOCAINE 4%Walgreensce1b21d6-7aa6-2b18-e053-2995a90a4c912024-12-11WarningsExact identifier
application number: M017
Walgreens Pain Burn Itch ReliefBENZOCAINE 20%, MENTHOL 0.5%Walgreenscc6e4b42-fdd8-6ff7-e053-2995a90a3d1d2024-12-11WarningsExact identifier
application number: M017
Pramoxine Itch reliefPRAMOXINE HCL 1%CVSe947694c-c122-0291-e053-2995a90ac39a2024-12-11WarningsExact identifier
application number: M017
Arthritis CreamTROLAMINE SALICYLATE 10%CVSd1663f50-479b-4d55-e053-2995a90a223f2024-12-11WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVSd1660d55-1ee0-7aa2-e053-2995a90a65792024-12-11WarningsExact identifier
application number: M017
CVS Muscle RubMENTHOL 10%, METHYL SALICYLATE 15%CVS Healthc72c9a95-4226-6d69-e053-2a95a90a8e1c2024-12-11WarningsExact identifier
application number: M017
BENGAY ULTRA STRENGTH NON-GREASYCAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND METHYL SALICYLATEKenvue Brands LLC0a41ec65-bd0b-4fc6-807d-74f353341cc72024-12-11WarningsExact identifier
application number: M017
Serum XLIDOCAINE HYDROCHLORIDEAO Biologix, LLCe07b6268-6400-6849-e053-2a95a90a8b3e2024-12-11WarningsExact identifier
application number: M017
PlusCBD Pain Cream (Penetrating) 2ozCAMPHOR, MENTHOLCV Sciences, Inc.ca39d327-6bf3-3408-e053-2a95a90af2d52024-12-11WarningsExact identifier
application number: M017
Blistex MedicatedDIMETHICONE, CAMPHOR (SYNTHETIC), MENTHOL, AND PHENOLBlistex Inc.e95439d3-f12b-4c1c-999a-79f2ddba4cfb2024-12-11WarningsExact identifier
application number: M017
Blistex Foille Medicated First AidBENZOCAINE AND CHLOROXYLENOLBlistex Inc.e2eca808-e97b-43e0-aa51-7025cc61c7a82024-12-11WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEJ&A Digital Inc.ff95a536-35b3-4006-b43c-cce359e86aa92024-12-10WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNeb031535-d17e-9d5e-e053-2a95a90ad3e04
106258hydrocortisone 10 MG/ML Topical CreamSCDeb031535-d17e-9d5e-e053-2a95a90ad3e04
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYeb031535-d17e-9d5e-e053-2a95a90ad3e04
106258hydrocortisone 1 % Topical CreamSYeb031535-d17e-9d5e-e053-2a95a90ad3e04
106258hydrocortisone 1 GM per 100 GM Topical CreamSYeb031535-d17e-9d5e-e053-2a95a90ad3e04

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0404-0166-500040401665072 BOX in 1 CASE (0404-0166-50) / 1 TUBE in 1 BOX / 28.4 g in 1 TUBE72 box2022-11-070000-00-00NoNoCurrent