FDA.reportPublic FDA data

DERMOSCRIBE ICHYBUM

Product NDC
69683-101
11-digit product format
696830101
Labeler code
69683
Product ID
69683-101_416176c4-52ba-8c6a-e063-6294a90a3584
Type
HUMAN OTC DRUG
Nonproprietary name
HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE
Dosage form
CREAM
Route
TOPICAL
Labeler
DERMOSCRIBE PTY LTD
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-03-23
Substance
HYDROCORTISONE; CLIOQUINOL
Active strength
1; 1 g/100g; g/100g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Increased Histamine Release [PE], Standardized Chemical Allergen [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
DERMOSCRIBE ICHYBUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g
CLIOQUINOL1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup
7BHQ856EJ5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1606483Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
134a88a1-13e5-4da0-8270-c380b57aaeb7Available 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
69683-101-11DERMOSCRIBE ICHYBUM28 g in 1 BOTTLECREAM2811

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
CLIOQUINOLACTIVE INGREDIENT7BHQ856EJ5DERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [XLMA PTY LTD]3
HYDROCORTISONEACTIVE INGREDIENTWI4X0X7BPJDERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [XLMA PTY LTD]3
CLIOQUINOLACTIVE MOIETY7BHQ856EJ5DERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [XLMA PTY LTD]3
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJDERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [XLMA PTY LTD]3
WATERINACTIVE INGREDIENT059QF0KO0RDERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [XLMA PTY LTD]3
ZINC OXIDEINACTIVE INGREDIENTSOI2LOH54ZDERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [XLMA PTY LTD]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69683-101DERMOSCRIBE ICHYBUM (HYDROCORTISONE, CLIOQUINOL, ZINC OXIDE) CREAM [DERMOSCRIBE PTY LTD]10Current NDC, Legacy NDC, 1 package rows20241109_134a88a1-13e5-4da0-8270-c380b57aaeb7.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 13 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
application number: M015
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact identifier
application number: M015
GoodSense Hemorrhoidal Pain ReliefGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLPerrigo Direct, Inc2e5f699d-45e8-6451-e063-6394a90a8ad82025-07-20WarningsExact identifier
application number: M015
Good Sense HemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLL. Perrigo Company379f8738-a871-4b09-abd1-c86386dfee042025-07-15WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal PadsWITCH HAZELWalmart, Inc.6dd8d3d9-5109-4869-917b-9521e9ba1ed02025-07-14WarningsExact identifier
application number: M015
Nikzon HemorrhoidalGLYCERIN, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, AND PRAMOXINE HYDROCHLORIDEGenomma Lab USA8f9a9939-2c99-489f-b597-9a51ec2684f92025-07-14WarningsExact identifier
application number: M015
ReVIVOL-XRPHENYLEPHRINE HYDROCHLORIDEUnipack LLC2950fe83-a2a4-4ed4-b645-69d6fd2381ae2025-07-13WarningsExact identifier
application number: M015
medicated wipesWITCH HAZELMeijer Distribution Inc.ba0f3f9a-95d1-4d8a-86d1-2c25c945118c2025-07-11WarningsExact identifier
application number: M015
hemorrhoidal padsWITCH HAZELMeijer Distribution Inc.53e39d22-a89e-4f95-8c64-abeb50f72ce72025-07-11WarningsExact identifier
application number: M015
INVIGOR OHLIDOCAINENatureplex LLC7c7b536d-e41a-4017-9df9-982e2e9cfe4e2025-07-10WarningsExact identifier
application number: M015
Maximum Strength Hemorrhoidal Cream with AloeGLYCERIN, PHENYLEPHINE HCI, PRAMOXINE HCI, PETROLATUMChain Drug Marketing Association396ea654-8be1-591a-e063-6294a90a11e22025-07-08WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF ANTI-ITCHHYDROCORTISONEHaleon US Holdings LLCd6148d77-ef6f-4552-b5ba-43b429923f192025-07-07WarningsExact identifier
application number: M015
Rectal Care CreamRECTAL CARE CREAMAllegiant Healthce585082-ad39-4b6f-a756-0d9a81a13eb82025-07-07WarningsExact identifier
application number: M015
Bisacodyl LaxativeBISACODYL LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cb0386-a662-6893-e063-6294a90aa71a2025-07-03WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMTrifecta Pharmaceuticals Usa Llc38cf4e43-280b-eb96-e063-6294a90a59492025-07-02WarningsExact identifier
application number: M015
TN Dickinsons Medicated Cooling Foam Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.deca8ae2-53a3-4c90-aa10-45354e2cdab82025-06-27WarningsExact identifier
application number: M015
Glycerin LaxativeGLYCERIN LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cc266a-196f-16ce-e063-6394a90a24af2025-06-20WarningsExact identifier
application number: M015
Phenylephrine HemorrhoidalHEMORRHOIDAL SUPPOSITORIESNeilmed Pharmaceuticals Inc.35ccb320-e902-3d1a-e063-6294a90a68d52025-06-20WarningsExact identifier
application number: M015
ProCure HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTwin Med LLC37a4cc43-0d53-f1bf-e063-6394a90a2dc92025-06-15WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefHEMORRHOIDAL PAIN RELIEF OINTMENTNeilmed Pharmaceuticals Inc.374d89b6-9305-9adf-e063-6394a90adb322025-06-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1606483hydrocortisone 1 % / clioquinol 1 % Rectal CreamPSN134a88a1-13e5-4da0-8270-c380b57aaeb711
1606483clioquinol 10 MG/ML / hydrocortisone 10 MG/ML Rectal CreamSCD134a88a1-13e5-4da0-8270-c380b57aaeb711
1606483hydrocortisone 1 % / clioquinol 1 % Rectal CreamSY134a88a1-13e5-4da0-8270-c380b57aaeb711

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69683-101-116968301011128 g in 1 BOTTLE (69683-101-11) 28 g2015-03-230000-00-00NoNoCurrent