FDA.reportPublic FDA data

Hydrocortisone

Product NDC
47682-211
11-digit product format
476820211
Labeler code
47682
Product ID
47682-211_3e4cb58c-fe23-ca13-e063-6394a90a7244
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Unifirst First Aid Corporation
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-04-15
Substance
HYDROCORTISONE
Active strength
10 mg/g
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
HYDROCORTISONE10 mg/g

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
e90df2e5-2ef4-47dd-bd74-be9cea6d9d85Available 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
47682-211-12Hydrocortisone10 in 1 BOXCREAM1018
47682-211-35Hydrocortisone144 in 1 BOXCREAM14418
47682-211-73Hydrocortisone25 in 1 BOXCREAM2518
47682-211-99Hydrocortisone0.9 g in 1 POUCHCREAM0.918

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
47682-211-35EA - Each47682-2116a5bddf1-e65b-48f5-9d50-c4d5bde8c88512015-10-02
47682-211-73EA - Each47682-211a3974d40-7864-46bf-a94d-8c5f517fcb6012015-10-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HydrocortisoneACTIVE INGREDIENTWI4X0X7BPJHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
HydrocortisoneACTIVE MOIETYWI4X0X7BPJHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
alcoholINACTIVE INGREDIENT3K9958V90MHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
methylparabenINACTIVE INGREDIENTA2I8C7HI9THYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
mineral oilINACTIVE INGREDIENTT5L8T28FGPHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
paraffinINACTIVE INGREDIENTI9O0E3H2ZEHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
petrolatumINACTIVE INGREDIENT4T6H12BN9UHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
waterINACTIVE INGREDIENT059QF0KO0RHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3
white waxINACTIVE INGREDIENT7G1J5DA97FHYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
47682-211HYDROCORTISONE CREAM [UNIFIRST FIRST AID CORPORATION]17Current NDC, Legacy NDC, 4 package rows20240118_e90df2e5-2ef4-47dd-bd74-be9cea6d9d85.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 125 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Bruise and Pain Relief Maximum StrengthCAMPHOR, MENTHOLAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions240b231d-a8b2-c64c-e063-6394a90a74402024-10-09WarningsExact identifier
application number: M017
Muscle Freeze ReliefMENTHOLNATURAL ESSENTIALS, INC.815c534b-096d-49f2-b5f2-8c885d45a5e62024-10-09WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONEVIVE HEALTH LLC2410dc2f-9332-19fa-e063-6394a90a28352024-10-09WarningsExact identifier
application number: M017
CVS Health Lidocaine Pain-RelievingLIDOCAINENatural Essentials, Inc.fc23b2e2-4abc-4119-b8bd-305b4327f1dd2024-10-09WarningsExact identifier
application number: M017
KERACAREMENTHOL 1%Avlon Industries, Inc.f72eec6d-1204-4e03-8aed-d5bcf8d3bbce2024-10-09WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharma, PTda338796-de9c-be51-e053-2a95a90a25092024-10-07WarningsExact identifier
application number: M017
Eagle MedicatedMENTHOL METHYL SALICYLATEEagle Indo Pharmae2c5f821-cdd5-190d-e053-2a95a90a91592024-10-07WarningsExact identifier
application number: M017
NanoXtreme Pain RelievingMENTHOL, METHYL SALICYLATEMG Science Technologies LLCc1490c30-a9db-4120-adaf-9e8000169e462024-10-07WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incea656cf8-cad5-4fa5-82e7-daec77a0bb042024-10-07WarningsExact identifier
application number: M017
Eagle Medicated Oil RefreshingMENTHOL, METHYL SALICYLATEEagle Indo Pharma, PTe2729023-d689-7ae2-e053-2a95a90a78dc2024-10-06WarningsExact identifier
application number: M017
Flanax Back Pain ReliefLIDOCAINEBelmora LLC46d33346-e582-4af1-b81a-feca7033dceb2024-10-04WarningsExact identifier
application number: M017
Muscle BalmMENTHOL, UNSPECIFIED FORM, CAMPHOR (SYNTHETIC)Natural Essentials, Inc.16918ba3-2e07-4232-9ed3-4c7751796cd22024-10-04WarningsExact identifier
application number: M017
Fast Freeze Pain Relieving ContinuousMENTHOL, UNSPECIFIED FORMNatural Essentials, Inc.998a4824-9ed9-4fe0-b45b-72e52861fcd32024-10-04WarningsExact identifier
application number: M017
Fast Freeze Lidocaine Roll-OnLIDOCAINE HYDROCHLORIDE, BENZYL ALCOHOLNatural Essentials, Inc.74b06366-5eb4-4eba-aa2b-2b672828294d2024-10-04WarningsExact identifier
application number: M017
Fast Freeze LidocaineLIDOCAINENatural Essentials, Inc.029bd3fb-1b5b-48e0-b9af-d91d548b5b0f2024-10-04WarningsExact identifier
application number: M017
Fast FreezeMENTHOLNatural Essentials Inc.a96e3e41-871c-4cf3-93b6-af2a6246ded82024-10-04WarningsExact identifier
application number: M017
CVS Pain ReliefMENTHOL 4%CVS20234356-5e80-b79e-e063-6294a90a2ee32024-10-04WarningsExact identifier
application number: M017
FLANAX BACK PAIN RELIEFLIDOCAINEBelmora Llcaf4bf57c-f250-4506-83eb-e0f253e960622024-10-04WarningsExact identifier
application number: M017
topcare hydrocortisoneHYDROCORTISONETopco Associates LLC11a30ec9-ebc2-4a00-8a8d-431d0d973b372024-10-03WarningsExact identifier
application number: M017
pain relief patchLIDOCAINE 4%Bionpharma Inc.19c69983-4e78-8ec5-e063-6394a90a84be2024-10-03WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNe90df2e5-2ef4-47dd-bd74-be9cea6d9d8518
106258hydrocortisone 10 MG/ML Topical CreamSCDe90df2e5-2ef4-47dd-bd74-be9cea6d9d8518
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYe90df2e5-2ef4-47dd-bd74-be9cea6d9d8518
106258hydrocortisone 1 % Topical CreamSYe90df2e5-2ef4-47dd-bd74-be9cea6d9d8518
106258hydrocortisone 1 GM per 100 GM Topical CreamSYe90df2e5-2ef4-47dd-bd74-be9cea6d9d8518
106258hydrocortisone 1 % Topical CreamPSN9578b39e-3df7-4d75-abd7-f1d5524545e51
106258hydrocortisone 10 MG/ML Topical CreamSCD9578b39e-3df7-4d75-abd7-f1d5524545e51
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY9578b39e-3df7-4d75-abd7-f1d5524545e51
106258hydrocortisone 1 % Topical CreamSY9578b39e-3df7-4d75-abd7-f1d5524545e51
106258hydrocortisone 1 GM per 100 GM Topical CreamSY9578b39e-3df7-4d75-abd7-f1d5524545e51

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
47682-211-124768202111210 POUCH in 1 BOX (47682-211-12) / .9 g in 1 POUCH (47682-211-99) 10 pouch2013-04-150000-00-00NoNoCurrent
47682-211-3547682021135144 POUCH in 1 BOX (47682-211-35) / .9 g in 1 POUCH (47682-211-99) 144 pouch2013-04-150000-00-00NoNoCurrent
47682-211-734768202117325 POUCH in 1 BOX (47682-211-73) / .9 g in 1 POUCH (47682-211-99) 25 pouch2013-04-150000-00-00NoNoCurrent
47682-211-99476820211990.9 g in 1 POUCH0.9 gHistorical