FDA.reportPublic FDA data

Hydrocortisone

Product NDC
68001-476
11-digit product format
680010476
Labeler code
68001
Product ID
68001-476_09bb7522-4299-8c71-e063-6294a90a0c24
Type
HUMAN OTC DRUG
Nonproprietary name
Antipruritic (Anti-Itch)
Dosage form
CREAM
Route
TOPICAL
Labeler
BluePoint Laboratories
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-11-27
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
b505769e-9c46-3cf3-e053-2a95a90a4df9Available 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
68001-476-46Hydrocortisone1 in 1 CARTONCREAM13
68001-476-46Hydrocortisone30 g in 1 TUBECREAM303
68001-476-50Hydrocortisone454 g in 1 JARCREAM4543

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68001-476-46GM - Gram68001-4767f1511b7-a8b0-4184-80e7-bc2d10a4c47912022-03-09
68001-476-50GM - Gram68001-476a7068894-c8f4-4414-9cbf-d8452552c79812022-03-09

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68001-476HYDROCORTISONE (ANTIPRURITIC (ANTI-ITCH)) CREAM [BLUEPOINT LABORATORIES]3Current NDC, Legacy NDC, 3 package rows20231118_b505769e-9c46-3cf3-e053-2a95a90a4df9.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 40 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Pain Relieving PatchLIDOCAINEFlexiGo Inc.4868af2a-c4be-9c68-e063-6394a90a565b2026-01-15WarningsExact identifier
application number: M017
Helocaine Cold Sore Fever Blister TreatmentTETRACAINE, MINERALPagari Life Science Corp.1b2eae09-5de0-9219-e063-6294a90af0462026-01-15WarningsExact identifier
application number: M017
Careland Lidocaine 4 Pain Relieving Gel-PatchesLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.a6ca8382-7ce5-4df9-912e-8a0ac04231162026-01-15WarningsExact identifier
application number: M017
Neuropathy CreamMENTHOL CREAMOwell Naturals Brand, LLC48739205-627b-41d0-e063-6394a90a34622026-01-15WarningsExact identifier
application number: M017
BLT 1BENZOCAINECENTURA PHARMACEUTICALS INC3eea2171-850b-4045-e054-00144ff8d46c2026-01-15WarningsExact identifier
application number: M017
Icy Hot Lidocaine DryLIDOCAINE, MENTHOLChattem, Inc.d500a74e-ab93-4919-8665-a89e9d4cad282026-01-15WarningsExact identifier
application number: M017
Cortizone 10 Bug Bite Relief1% HYDROCORTISONEChattem, Inc.b21b6c04-8246-4567-98cf-64e8c588e79c2026-01-15WarningsExact identifier
application number: M017
Gold Bond Intensive Relief Anti-ItchPRAMOXINE HYDROCHLORIDE, MENTHOLChattem, Inc.e5a3f8d4-b3d8-4b88-b9a9-833406d3e6f82026-01-14WarningsExact identifier
application number: M017
Cortizone-10 Soothing Aloe CremeHYDROCORTISONEChattem, Inc.1a841bf0-9d7b-4566-b442-aa9bcc8278462026-01-14WarningsExact identifier
application number: M017
Cortisone 10 Sensitive Skin CremeHYDROCORTISONEChattem, Inc.b139917c-00bb-4cb3-995d-a6d2f2c295c62026-01-14WarningsExact identifier
application number: M017
Cortizone 10 for PsoriasisHYDROCORTIZONEChattem, Inc.fad9eedb-95e1-4e1a-91e5-0bfd077e0cf52026-01-14WarningsExact identifier
application number: M017
Pain Relief Roll OnTOPICAL ANALGESICEagle Labs Inc2380a400-062a-4a8d-a594-a2e0972190442026-01-14WarningsExact identifier
application number: M017
LidocaineLIDOCAINE 4%AvKARE70aace2f-47b4-e961-e053-2991aa0a63672026-01-14WarningsExact identifier
application number: M017
JUST CBD - ULTRA RELIEFMENTHOL, CAMPHORJust Brands LLC485f355a-4458-67b6-e063-6394a90ab2a02026-01-14WarningsExact identifier
application number: M017
Relief Pain Relieving CreamMENTHOLCorganics, LP85814fff-35f8-447f-b669-87eaf55e98592026-01-14WarningsExact identifier
application number: M017
Mentholatum Soothing Vapor Rub CherryCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company486269c9-af3a-7856-e063-6294a90a378c2026-01-14WarningsExact identifier
application number: M017
Mentholatum Vapor MaxCAMPHOR, EUCALYPTUS OIL, MENTHOLThe Mentholatum Company4863606f-f7c8-b4a4-e063-6294a90a11382026-01-14WarningsExact identifier
application number: M017
Hydrocortisone Cream Intensive HealingHYDROCORTISONE CREAMWalgreens8a3f486c-1353-466d-9ea7-c14559b53bf32026-01-14WarningsExact identifier
application number: M017
Maximum Strength Hydrocortisone Cream with AloeHYDROCORTISONE CREAMWalgreense8f69c4b-2570-477e-9c6d-d552d30ac0d02026-01-14WarningsExact identifier
application number: M017
HydrocortisoneCOOL RELIEF GEL WITH ALOEWalgreens1ae2b37d-d5b2-74d2-e063-6294a90a0de02026-01-14WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNb505769e-9c46-3cf3-e053-2a95a90a4df93
106258hydrocortisone 10 MG/ML Topical CreamSCDb505769e-9c46-3cf3-e053-2a95a90a4df93
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYb505769e-9c46-3cf3-e053-2a95a90a4df93
106258hydrocortisone 1 % Topical CreamSYb505769e-9c46-3cf3-e053-2a95a90a4df93
106258hydrocortisone 1 GM per 100 GM Topical CreamSYb505769e-9c46-3cf3-e053-2a95a90a4df93

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68001-476-46680010476461 TUBE in 1 CARTON (68001-476-46) / 30 g in 1 TUBE1 tube2020-11-270000-00-00NoNoCurrent
68001-476-5068001047650454 g in 1 JAR (68001-476-50) 454 g2020-11-270000-00-00NoNoCurrent