FDA.reportPublic FDA data

Hydrocortisone

Product NDC
37808-319
11-digit product format
378080319
Labeler code
37808
Product ID
37808-319_194ade5a-3f75-4d50-a6d7-4cdb4b70a241
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
H E B
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-09-11
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

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 10 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-319-16Hydrocortisone1 in 1 CARTONCREAM15
37808-319-16Hydrocortisone56 g in 1 TUBECREAM565
37808-319-64Hydrocortisone28 g in 1 TUBECREAM285
37808-319-64Hydrocortisone1 in 1 CARTONCREAM15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [H E B]1
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [H E B]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XHYDROCORTISONE CREAM [H E B]1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SHYDROCORTISONE CREAM [H E B]1
CETYL PALMITATEINACTIVE INGREDIENT5ZA2S6B08XHYDROCORTISONE CREAM [H E B]1
GLYCERININACTIVE INGREDIENTPDC6A3C0OXHYDROCORTISONE CREAM [H E B]1
ISOPROPYL MYRISTATEINACTIVE INGREDIENT0RE8K4LNJSHYDROCORTISONE CREAM [H E B]1
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [H E B]1
POLYOXYL 20 CETOSTEARYL ETHERINACTIVE INGREDIENTYRC528SWUYHYDROCORTISONE CREAM [H E B]1
WATERINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [H E B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-319HYDROCORTISONE CREAM [H E B]5Current NDC, Legacy NDC, 4 package rows20241101_15eb4676-5f6e-4c28-b5b9-4e45412dc37a.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 136 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Leader Burn ReliefLIDOCAINECardinal Healthf4e8e3b7-fd84-bdbc-e053-2a95a90aeab22024-02-06WarningsExact identifier
application number: M017
Pain Relieving Petro CarboPHENOLJ.R. Watkins, LLC.050cf17d-3be7-45b9-8524-ad82af309a0e2024-02-06WarningsExact identifier
application number: M017
White CreamCAMPHOR (NATURAL) AND TURPENTINE OILJ.R. Watkins, LLC.e4de0734-59d5-478c-86ea-66fc2ba003e72024-02-05WarningsExact identifier
application number: M017
Pain Relieving Roll-OnMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.80118260-9c88-402d-9a90-ecfe62b4b54f2024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOL, UNSPECIFIED FORMSafetec of America, Inc.df512ce6-ce1b-434d-9571-fb2e1d76e1d02024-02-05WarningsExact identifier
application number: M017
Pain RelievingMENTHOLSafetec of America, Inc.52ebf64d-095f-467e-bf51-dd8d33b58c7d2024-02-05WarningsExact identifier
application number: M017
Itch ReliefDIPHENHYDRAMINE HYDROCHLORIDESafetec of America, Inc.4f4c801b-d894-4fa3-b024-6ca41a5f2a952024-02-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.79e3b0e7-4ba5-4b9d-a980-5b6f18dba8022024-02-04WarningsExact identifier
application number: M017
HAV EZ Penetrating Pain ReliefMENTHOLPALM ORTHOPEDICS & INTERVENTIONAL PAIN LLC70006efc-9cc8-4490-b28c-fcb23b1737c42024-02-01WarningsExact identifier
application number: M017
Rugby Capsaicin External AnalgesicCAPSAICINProficient Rx LP7c733a30-5002-49e7-a6bd-7737a1d2461e2024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPccb62898-b614-45b9-95ea-23e5e31893a82024-02-01WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEProficient Rx LP0b26d92f-9d0e-46d4-a8bc-75d6da5f61992024-02-01WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONEProficient Rx LPc57d5f8e-5934-4cbb-999a-cdd55e5b105f2024-02-01WarningsExact identifier
application number: M017
hydrocortisoneHYDROCORTISONEProficient Rx LP47e9fe84-bd0c-40ea-85de-e950bcacc5572024-02-01WarningsExact identifier
application number: M017
Joint and Muscle PainMENTHOLShaklee Corporation3943824f-1f4f-4d6f-bd73-0b1be02162a52024-01-30WarningsExact identifier
application number: M017
Mirakel Pain Relief Roll-OnLIDOCAINE HCLSanvio, Inc.102f3618-13ad-37e3-e063-6294a90a80862024-01-30WarningsExact identifier
application number: M017
Blistex Lip MedexPETROLATUM, MENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC), AND PHENOLBlistex Inc.8ad39005-9419-4f1a-a1ae-2f76d212455e2024-01-26WarningsExact identifier
application number: M017
Point Relief Cold Spot Pain RelievingMENTHOLFabrication Enterprisesad5d6f04-15e6-4548-95c2-32271c186bc12024-01-25WarningsExact identifier
application number: M017
MIND BODY MATRIX PAIN RELIEFMENTHOLFunctional Energetic, Inc.3667dd0d-942e-4101-ba98-cb013ae77cf52024-01-25WarningsExact identifier
application number: M017
SUPER WHITE STUFF Pain ReliefMENTHOLBLUE SPRING WELLNESSe6d27df5-118c-4c6d-86e8-7b4401a39c762024-01-23WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSN15eb4676-5f6e-4c28-b5b9-4e45412dc37a5
106258hydrocortisone 10 MG/ML Topical CreamSCD15eb4676-5f6e-4c28-b5b9-4e45412dc37a5
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY15eb4676-5f6e-4c28-b5b9-4e45412dc37a5
106258hydrocortisone 1 % Topical CreamSY15eb4676-5f6e-4c28-b5b9-4e45412dc37a5
106258hydrocortisone 1 GM per 100 GM Topical CreamSY15eb4676-5f6e-4c28-b5b9-4e45412dc37a5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-319-16378080319161 TUBE in 1 CARTON (37808-319-16) / 56 g in 1 TUBE1 tube2024-10-16NoNoCurrent
37808-319-64378080319641 TUBE in 1 CARTON (37808-319-64) / 28 g in 1 TUBE1 tube2015-09-110000-00-00NoNoCurrent