FDA.reportPublic FDA data

hydrocortisone

Product NDC
72162-2284
11-digit product format
721622284
Labeler code
72162
Product ID
72162-2284_b4a9df12-006d-4cb4-a4cf-6137de997c70
Type
HUMAN OTC DRUG
Nonproprietary name
hydrocortisone
Dosage form
OINTMENT
Route
TOPICAL
Labeler
Bryant Ranch Prepack
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-08-18
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

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

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
203105Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
99726aa3-3b45-4175-8471-279419af5457Available 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
72162-2284-2hydrocortisone1 in 1 CARTONOINTMENT13
72162-2284-2hydrocortisone28 g in 1 TUBEOINTMENT283

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72162-2284-2GM - Gram72162-2284cdd2ab2e-cd07-47c3-875d-4bfa57066a2912024-06-10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72162-2284HYDROCORTISONE OINTMENT [BRYANT RANCH PREPACK]2Current NDC, 2 package rows20240921_99726aa3-3b45-4175-8471-279419af5457.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 92 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Numbing CreamLIDOCAINE100 KARMA INC359884d6-188a-e503-e063-6294a90acab42025-05-20WarningsExact identifier
application number: M017
AY BENDITO - THERMOACTIVECAMPHOR, MENTHOLAY BENDITO - THERMOACTIVE LOTION835abc66-680f-be06-e053-2a91aa0a309e2025-05-19WarningsExact identifier
application number: M017
Numbing CreamLIDOCAINE100 KARMA INC35884644-d017-eda3-e063-6394a90a1f6c2025-05-19WarningsExact identifier
application number: M017
QUIT SMOKING Proven PatchesNICOTINEJiashen International Trade Limited35570155-c769-dc4c-e063-6394a90a019d2025-05-17WarningsExact identifier
application number: M017
VBBV Tattoo NumbingLIDOCAINEJiashen International Trade Limited3557859e-f8b3-1049-e063-6394a90ad7372025-05-17WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company35415851-beba-5bb4-e063-6294a90a35c02025-05-16WarningsExact identifier
application number: M017
Cold Hot Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd352798e1-1e09-3d47-e063-6394a90ad4042025-05-15WarningsExact identifier
application number: M017
Plantar Fasciitis Chinese Red Tiger Pain Relief Gel Roll-OnMENTHOLGuangzhou Zhupuyou E-commerce Co., Ltd35285d62-c660-a056-e063-6294a90aabc82025-05-15WarningsExact identifier
application number: M017
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
application number: M017
Bliss Republic Lidocaine Numbing CreamLIDOCAINE NUMBING CREAMSargass Group Limited Liability Company3508ae14-d9c9-3c85-e063-6294a90a00982025-05-13WarningsExact identifier
application number: M017
SORE NO MORE WARM THERAPYMENTHOL AND CAMPHORSOMBRA COSMETICS INC.cd86b56e-9b4c-4aca-9740-c8793cb120552025-05-12WarningsExact identifier
application number: M017
SORE NO MORE COOL THERAPYMENTHOLSOMBRA COSMETICS INC.9aa1f0ac-3baf-4e45-9e3a-c28a99b229092025-05-12WarningsExact identifier
application number: M017
Calm and Correct Serum with LidocaineLIDOCAINE 3 PERCENTRenu Laboratories, LLCddcf1c2e-2f67-44d7-e053-2a95a90a812b2025-05-09WarningsExact identifier
application number: M017
Mqupin Knee PatchKNEE PATCHZhengzhou Miaoqi Pharmaceutical Technology Co., Ltd09772e4b-8193-3771-e063-6394a90a95162025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USAd57a59fb-c8f2-f73b-e053-2995a90a4cdb2025-05-08WarningsExact identifier
application number: M017
Hydrocortisone CreamHYDROCORTISONETrifecta Pharmaceuticals USA4c96ec41-841c-322b-e054-00144ff8d46c2025-05-08WarningsExact identifier
application number: M017
GNP Extra Strength Anti-Itch CreamDIPHENHYDRAMINE HYDROCHLORIDE, ZINC ACETATEAmerisource Bergen34a66224-ef3c-e36e-e063-6394a90ac99d2025-05-08WarningsExact identifier
application number: M017
Good Neighbor Muscle Rub CreamCAMPHOR 4.0%, MENTHOL 10.0%, METHYL SALICYLATE 30.0%,Amerisource Bergen34924bb9-e3e8-70e6-e063-6294a90aaa8c2025-05-07WarningsExact identifier
application number: M017
DermaRad Relief Post Radiation CalmingLIDOCAINE 3 PERCENTRenu Laboratories, LLCe5d64929-fb9c-7ebc-e053-2995a90a93182025-05-07WarningsExact identifier
application number: M017
Cold Hot Medicated Patch 5% MentholMENTHOLInterMed Laboratories Private Limited33ee0235-5a6e-0ea1-e063-6394a90a89a52025-05-06WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
203105hydrocortisone 1 % Topical OintmentPSN99726aa3-3b45-4175-8471-279419af54573
203105hydrocortisone 0.01 MG/MG Topical OintmentSCD99726aa3-3b45-4175-8471-279419af54573
203105hydrocortisone 1 % Topical OintmentSY99726aa3-3b45-4175-8471-279419af54573

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
72162-2284-2721622284021 TUBE in 1 CARTON (72162-2284-2) / 28 g in 1 TUBE1 tube2011-08-18NoNoCurrent