Hydrocortisone

Product NDC
67777-003
Requested package NDC
67777-003-01
11-digit product format
677770003
Labeler code
67777
Product ID
67777-003_ef401189-5905-6c38-e053-2995a90a5704
Type
HUMAN OTC DRUG
Nonproprietary name
Antipruritic (Anti-itch)
Dosage form
CREAM
Route
TOPICAL
Labeler
Dynarex Corporation
Application
part348
Marketing category
OTC MONOGRAPH NOT FINAL
Marketing start
2018-05-03
Marketing end
0000-00-00
Substance
HYDROCORTISONE ACETATE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage67777-00367777-003-01IInactivated by FDA2026-10-05

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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
67777-003-012026-01-29C16284748780-149896155-a591-586f-e063-e6dba90add901137 Hydrocortisone Cream NDC 67777-003-01

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
67777-003-01Hydrocortisone1728 in 1 CASECREAM17287
67777-003-02Hydrocortisone144 in 1 BOXCREAM1447
67777-003-02Hydrocortisone0.9 g in 1 PACKETCREAM0.97

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67777-003HYDROCORTISONE (ANTIPRURITIC (ANTI-ITCH)) CREAM [DYNAREX CORPORATION]7Legacy NDC, 3 package rows20241122_81ccb562-0cbc-07e4-e053-2a91aa0aaea3.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN81ccb562-0cbc-07e4-e053-2a91aa0aaea37
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD81ccb562-0cbc-07e4-e053-2a91aa0aaea37
1043690hydrocortisone acetate 1 % Topical CreamSY81ccb562-0cbc-07e4-e053-2a91aa0aaea37

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
67777-003-01677770003011728 BOX in 1 CASE (67777-003-01) > 144 PACKET in 1 BOX (67777-003-02) > .9 g in 1 PACKET1728 box2018-05-030000-00-00NoNoCurrent