FDA.reportPublic FDA data

procure

Product NDC
55681-224
11-digit product format
556810224
Labeler code
55681
Product ID
55681-224_5827cacf-af4e-a06e-e063-6294a90aea43
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone Acetate
Dosage form
OINTMENT
Route
TOPICAL
Labeler
TWIN MED, LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-02-05
Marketing end
2029-03-31
Substance
HYDROCORTISONE ACETATE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag
No
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
procure

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE ACETATE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3X7931PO74Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1440184Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2670c9c4-66ad-40e8-a08a-582b160de39dAvailable 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
55681-224-02procure144 in 1 BOXOINTMENT14413
55681-224-02procure0.9 g in 1 PACKETOINTMENT0.913
55681-224-03procure28.3 g in 1 TUBEOINTMENT28.313

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
CETETH-20INACTIVE INGREDIENTI835H2IHHXPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1SPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
CHLOROCRESOLINACTIVE INGREDIENT36W53O7109PROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
EDETATE SODIUMINACTIVE INGREDIENTMP1J8420LUPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
MINERAL OILINACTIVE INGREDIENTT5L8T28FGPPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3PROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3CPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2
WATERINACTIVE INGREDIENT059QF0KO0RPROCURE (HYDROCORTISONE) OINTMENT [TWIN MED, LLC]2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55681-224PROCURE (HYDROCORTISONE ACETATE) OINTMENT [TWIN MED, LLC]12Current NDC, Legacy NDC, 3 package rows20240109_2670c9c4-66ad-40e8-a08a-582b160de39d.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 80 of 151 · 3,020 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
YehealCAMPHOR, MENTHOL, ISOPROPYL ALCOHOLShenzhen Yeheal Biotechnology Co., Ltd3cf1bc74-3060-6d63-e063-6294a90a9f5c2025-08-22WarningsExact identifier
application number: M017
Dermedial Anti-OuchMENTHOLNatures Formulae Health Products Ltd.3ce29160-3964-e435-e063-6394a90abb382025-08-21WarningsExact identifier
application number: M017
SUGARLOAF ORGANICS MENTHOL REVIVEMENTHOLRENU LABORATORIES, LLCfa2f9539-b703-a00b-e053-6394a90ae3092025-08-21WarningsExact identifier
application number: M017
Camphor 4% Plus Menthol 10%CAMPHOR 4% PLUS MENTHOL 10%PureTek Corporation3cab26e4-e377-f26a-e063-6394a90a17af2025-08-20WarningsExact identifier
application number: M017
Capsaicin 0.035% CreamCAPSAICIN 0.035% CREAMPuretekcorp3cbc73b6-8c58-8f23-e063-6394a90a71a32025-08-20WarningsExact identifier
application number: M017
Game OnMENTHOL, METHYL SALICYLATENatural Essentials, Inc.3cd20f1f-033f-f698-e063-6294a90a89eb2025-08-20WarningsExact identifier
application number: M017
ELAIMEI Numbing CreamLIDOCAINE 4%Shenzhen Shandian Jingling Technology Co., Ltd.37ac13b2-ca55-0e28-e063-6294a90a000e2025-08-19WarningsExact identifier
application number: M017
Calamine Plus Pramoxine HClCALAMINE PLUS SPRAYFSA Store Inc.3cd18f96-34f7-3f2c-e063-6294a90a3b7e2025-08-19WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONE SPRAYFSA Store Inc.3ce24b87-55ac-0bbd-e063-6294a90ab5822025-08-19WarningsExact identifier
application number: M017
Fast Freeze Pain RelievingMENTHOL, UNSPECIFIED FORMNATURAL ESSENTIALS, INC.15a26af1-ca5a-40fc-a411-6c0e8ae18fbb2025-08-18WarningsExact identifier
application number: M017
Orythia Maximum Strength Lidocaine Pain RelievingLIDOCAINEPlanet (Anhui) Pharmaceutical Co., Ltd.6d6b59f9-f614-4e3c-b07b-32b4591d39f22025-08-18WarningsExact identifier
application number: M017
Ocean Potion Suncare Ice Plus Pain Relieving SoothingLIDOCAINEGNL BRANDS INTERNATIONAL, LLC3c69654c-cba6-dfef-e063-6394a90ad4792025-08-15WarningsExact identifier
application number: M017
Earth Mama Medicated Herbal Lip BalmMENTHOLEleeo Brands LLC3c6c16bb-1f4b-b851-e063-6294a90a74042025-08-15WarningsExact identifier
application number: M017
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDECintas First Aid & Safety96f17095-31f3-4b8a-ab22-0caaefaa74762025-08-15WarningsExact identifier
application number: M017
MedPride Cold Ice Analgesic GelMENTHOLSHIELD LINE LLC860a2c86-b240-4e0e-e053-2a91aa0a333a2025-08-15WarningsExact identifier
application number: M017
MedPride Medicated Body Powder PowderMENTHOL, ZINC OXIDEShield Line LLCcdb2fa5b-cf04-c876-e053-2a95a90a187c2025-08-15WarningsExact identifier
application number: M017
BurnLIDOCAINEHART Healthc5ff392a-e788-43e0-91ea-5e0f8420586c2025-08-15WarningsExact identifier
application number: M017
Stopain ClinicalMENTHOLTroy Manufacturing, Inc.40df30ba-41ba-42b7-93fe-4183b57bdb002025-08-14WarningsExact identifier
application number: M017
Signature Care Aloe Vera Gel with LidocaineLIDOCAINESafeway, Inc.d5069622-97b1-ba12-e053-2a95a90a72682025-08-14WarningsExact identifier
application number: M017
METHYL SALICYLATE 25%METHYL SALICYLATEOncora Pharma, LLC3c4bc55d-6582-3b5e-e063-6394a90a994c2025-08-13WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1440184hydrocortisone acetate 1 % Topical OintmentPSN2670c9c4-66ad-40e8-a08a-582b160de39d13
1440184hydrocortisone acetate 0.01 MG/MG Topical OintmentSCD2670c9c4-66ad-40e8-a08a-582b160de39d13
1440184hydrocortisone acetate 1 % Topical OintmentSY2670c9c4-66ad-40e8-a08a-582b160de39d13

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55681-224-0255681022402144 PACKET in 1 BOX (55681-224-02) / .9 g in 1 PACKET144 packet2013-02-052029-03-31NoNoCurrent
55681-224-035568102240328.3 g in 1 TUBE (55681-224-03) 28.3 g2022-08-182029-03-31NoNoCurrent