FDA.reportPublic FDA data

Hydrocortisone

Product NDC
67777-004
11-digit product format
677770004
Labeler code
67777
Product ID
67777-004_0fa32e68-a566-6d7e-e063-6394a90af08b
Type
HUMAN OTC DRUG
Nonproprietary name
Antipruritic (Anti-Itch)
Dosage form
CREAM
Route
TOPICAL
Labeler
Dynarex Corporation
Application
M032
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-03-25
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
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
81dff9df-6f7e-49f0-e053-2a91aa0af7e7Available 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
67777-004-01Hydrocortisone72 in 1 CASECREAM726
67777-004-02Hydrocortisone1 in 1 BOXCREAM16
67777-004-02Hydrocortisone28.4 g in 1 TUBECREAM28.46
67777-004-03Hydrocortisone0.9 g in 1 PACKETCREAM0.96
67777-004-03Hydrocortisone144 in 1 BOXCREAM1446
67777-004-04Hydrocortisone12 in 1 CASECREAM126
67777-004-05Hydrocortisone600 in 1 CASECREAM6006
67777-004-06Hydrocortisone6 in 1 BOXCREAM66
67777-004-06Hydrocortisone0.9 g in 1 PACKETCREAM0.96
67777-004-07Hydrocortisone1800 in 1 CASECREAM18006
67777-004-08Hydrocortisone25 in 1 BOXCREAM256
67777-004-08Hydrocortisone0.9 g in 1 PACKETCREAM0.96

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
67777-004-01GM - Gram67777-0046c247f91-33bb-4cd2-8f53-be407879b0d212023-07-06
67777-004-02GM - Gram67777-004fe8b94f0-0824-49d0-9a3b-463ac914026c12023-07-06
67777-004-03EA - Each67777-004205cd319-7b85-423f-ba64-31687601096d12023-07-06
67777-004-04EA - Each67777-0045571e862-afb8-49c7-93e5-8c1205bc4a9b12023-07-06

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-004HYDROCORTISONE (ANTIPRURITIC (ANTI-ITCH)) CREAM [DYNAREX CORPORATION]6Current NDC, Legacy NDC, 12 package rows20240124_81dff9df-6f7e-49f0-e053-2a91aa0af7e7.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 23 of 31 · 615 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermaharmony Face and BodyPYRITHIONE ZINCD3 Development, Inc.bd72b53c-b22c-40d0-e053-2995a90af9c12024-12-20WarningsExact identifier
application number: M032
Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.637851c6-ff4a-8bbc-e053-2991aa0a963c2024-12-20WarningsExact identifier
application number: M032
Dermaharmony Zinc TherapyPYRITHIONE ZINCD3 Development, Inc.cb442483-b735-01a0-e053-2995a90aaff52024-12-20WarningsExact identifier
application number: M032
Dermaharmony Pyrithione Zinc with Shea ButterPYRITHIONE ZINCD3 Development, Inc.dc7ba02c-bdbd-5136-e053-2995a90ac5452024-12-20WarningsExact identifier
application number: M032
Dermaharmony Tea Tree BarPYRITHIONE ZINCD3 Development, Inc.e9d5eb14-1840-ae21-e053-2a95a90aa3212024-12-20WarningsExact identifier
application number: M032
Dermaharmony Unscented BarPYRITHIONE ZINCD3 Development, Inc.e9d66c9c-5fb1-0a90-e053-2a95a90ab7a42024-12-20WarningsExact identifier
application number: M032
BYE-BYE CRADLE CAPPYRITHIONE ZINCTubby Toddf4398ad2-7da5-aff0-e053-2995a90ae2662024-12-12WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFPYRITHIONE ZINCDavines S.p.A.1f7e0265-0543-4ef9-addf-4d514d0eedfe2024-12-11WarningsExact identifier
application number: M032
NATURALTECH PURIFYING ANTI-DANDRUFFSELENIUM SULFIDEDavines S.p.A.369a24fd-3882-4fad-b57a-45806090aff12024-12-11WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsb5ea8f33-8f18-7464-e053-2a95a90a39b22024-12-09WarningsExact identifier
application number: M032
Skin Renewing CreamSALICYLIC ACIDAllure Labsfa54cf42-3ba7-b7b3-e053-6394a90aa7a02024-12-09WarningsExact identifier
application number: M032
Satinique Anti Dandruff Scalp and HairSALICYLIC ACIDAccess Business Group LLC03252c61-c51b-4e87-a06d-a61b8393704f2024-12-09WarningsExact identifier
application number: M032
Dry Skin Relief BarSALICYLIC ACIDCP Skin Health Group, Inc.eceb73b0-4c2f-4989-a3aa-a6553bc682522024-12-09WarningsExact identifier
application number: M032
Head and Shoulders Dual Pack Green ApplePYRITHIONE ZINCThe Procter & Gamble Manufacturing Companyc8208bac-9d32-7694-e053-2a95a90a746c2024-11-27WarningsExact identifier
application number: M032
VanicreamPYRITHIONE ZINCPharmaceutical Specialties, Inc.d124a093-f739-0666-e053-2995a90a52ed2024-11-27WarningsExact identifier
application number: M032
LEAHUE MADHUCA TONICSALICYLIC ACIDBio-interchange Co.81454c8a-ddcf-7cef-e053-2991aa0a53c22024-11-27WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Oily, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.b09c3b0d-564e-45e4-b6ff-c1f0c12a95212024-11-13WarningsExact identifier
application number: M032
Hairitage Wash It Away Anti-Dandruff for Dry, Flaky ScalpSELENIUM SULFIDEMaesa, LLC.fa5d4ee3-fbeb-4379-bbd3-2b5b2cc454302024-11-12WarningsExact identifier
application number: M032
Marcs 2 in 1 Everyday Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.1daaa2c9-fbc7-4aa5-9772-e157109320662024-11-11WarningsExact identifier
application number: M032
Marcs Dry Scalp Care Dandruff Anti-DandruffPYRITHIONE ZINCMark Glassman, Inc.ffab6ca6-7c8f-4080-836c-635a6ba3c0bb2024-11-11WarningsExact identifier
application number: M032

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN81dff9df-6f7e-49f0-e053-2a91aa0af7e76
106258hydrocortisone 10 MG/ML Topical CreamSCD81dff9df-6f7e-49f0-e053-2a91aa0af7e76
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY81dff9df-6f7e-49f0-e053-2a91aa0af7e76
106258hydrocortisone 1 % Topical CreamSY81dff9df-6f7e-49f0-e053-2a91aa0af7e76
106258hydrocortisone 1 GM per 100 GM Topical CreamSY81dff9df-6f7e-49f0-e053-2a91aa0af7e76

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-004-016777700040172 BOX in 1 CASE (67777-004-01) / 1 TUBE in 1 BOX (67777-004-02) / 28.4 g in 1 TUBE72 box2021-03-250000-00-00NoNoCurrent
67777-004-02677770004021 in 1 BOXHistorical
67777-004-03677770004030.9 g in 1 PACKET0.9 gHistorical
67777-004-046777700040412 BOX in 1 CASE (67777-004-04) / 144 PACKET in 1 BOX (67777-004-03) / .9 g in 1 PACKET12 box2021-03-250000-00-00NoNoCurrent
67777-004-0567777000405600 BOX in 1 CASE (67777-004-05) / 6 PACKET in 1 BOX (67777-004-06) / .9 g in 1 PACKET600 box2021-03-25NoNoCurrent
67777-004-06677770004066 in 1 BOXHistorical
67777-004-07677770004071800 BOX in 1 CASE (67777-004-07) / 25 PACKET in 1 BOX (67777-004-08) / .9 g in 1 PACKET1800 box2021-03-25NoNoCurrent
67777-004-086777700040825 in 1 BOXHistorical