FDA.reportPublic FDA data

CliniCalm

Product NDC
68726-504
11-digit product format
687260504
Labeler code
68726
Product ID
68726-504_2865dbce-02f6-ebe7-e063-6294a90ab3cb
Type
HUMAN OTC DRUG
Nonproprietary name
Hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
CP Skin Health Group, Inc.
Application
M006
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-07-01
Substance
HYDROCORTISONE
Active strength
1 g/100g
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
CliniCalm
Listing expiration
2026-12-31

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
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
febcf7e8-668c-a5c9-e053-6394a90aec39Available 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
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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
68726-504-01CliniCalm7 g in 1 TUBECREAM76
68726-504-02CliniCalm1 in 1 CARTONCREAM16
68726-504-02CliniCalm60 g in 1 TUBECREAM606

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68726-504CLINICALM (HYDROCORTISONE) CREAM [CP SKIN HEALTH GROUP, INC.]6Current NDC, 3 package rows20241206_febcf7e8-668c-a5c9-e053-6394a90aec39.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 44 of 54 · 1,079 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
MDacne Body Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc97529268-c45c-49c0-8eb0-15c90def69ea2024-09-19WarningsExact identifier
application number: M006
MDacne Customized Acne Cleanser Hydrating Salicylic AcidSALICYLIC ACIDMDAlgorithms Incff01a623-327d-4350-819f-68188c82b9122024-09-19WarningsExact identifier
application number: M006
Aveeno clear complexion daily moisturizerSALICYLIC ACIDKenvue Brands LLCc13dac31-bccb-4fcc-81c4-90e3e63ba59f2024-09-12WarningsExact identifier
application number: M006
MY BEAUTY SPOT Acne Care Patch KitSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.9bec6363-bc71-47fa-8732-33fa7cc58d6c2024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Vitamin ASALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ad7e5be5-7e20-4616-8094-8dae43cfc0052024-09-10WarningsExact identifier
application number: M006
Healing Acne Care Patches - Tea Tree and Salicylic AcidSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.ec37a585-3adb-4829-93d1-7814adbdc0962024-09-10WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACID CREAMChina Ningbo Shangge Cosmetics Technology Corp.21cedce7-61e0-6479-e063-6294a90abf5d2024-09-10WarningsExact identifier
application number: M006
benzoyl peroxideBENZOYL PEROXIDEBryant Ranch Prepack4ea1d07e-b39f-4afb-85ae-0b3c544ac3c72024-09-06WarningsExact identifier
application number: M006
Spot Acne Treatment Oil Free 0.75ozSALICYLIC ACIDRejoice International Corp.212f77ca-82d3-6a78-e063-6394a90aed322024-09-02WarningsExact identifier
application number: M006
HEALING BLEMISH DOTSSALICYLIC ACIDGanzhou Olivee Cosmetic Co., Ltd.4e62aee6-978d-4439-83cd-ee24882450e72024-08-28WarningsExact identifier
application number: M006
amazon basics step 3 treatment Acne medicationBENZOYL PEROXIDEAMAZON.COM SERVICES LLCe104ea51-816c-4565-a829-b03957d3d9622024-08-28WarningsExact identifier
application number: M006
amazon basics step 1 cleanser Acne treatmentBENZOYL PEROXIDEAMAZON.COM SERVICES LLC23a060f0-d379-4370-9a79-ca6e854419b42024-08-26WarningsExact identifier
application number: M006
SEYTU SpotSALICYLIC ACIDOmnilife USA, Inc.68252aa0-36cd-4380-8898-16a5e47318662024-08-23WarningsExact identifier
application number: M006
Peach Slices 3 Step Acne Starter KitSALICYLIC ACIDPeach & Lily, Inc0c8860ca-5376-4e98-a7a9-4668dff4f0aa2024-08-14WarningsExact identifier
application number: M006
PHARMA CLEAR CLEANSERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCd2c39d80-5ccd-43a8-a8bf-eba502bfdbf12024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR MOISTURIZERSALICYLIC ACIDPHARMAGEL INTERNATIONAL INCc4c08475-bafa-4bb1-92a5-e94e600862642024-08-13WarningsExact identifier
application number: M006
PHARMA CLEAR ACNE TREATMENTSALICYLIC ACIDPHARMAGEL INTERNATIONAL INC6d94f911-d751-45e4-b24d-8d85c6a3cefb2024-08-13WarningsExact identifier
application number: M006
Anti-Everything Face SerumSALICYLIC ACID SERUMBentley laboratories, llC8330e61c-50ec-44a5-91d9-a97e5a9d03882024-08-05WarningsExact identifier
application number: M006
Anti-Everything Face MoisturizerSALICYLIC ACID CREAMBentley Laboratories, LLC36cb28f2-2620-4b88-811f-a2d6c1e22e792024-08-05WarningsExact identifier
application number: M006
Tucks Medicated Cooling PadsWITCH HAZELBlistex Inc1eb3c742-7104-7b47-e063-6394a90a84ba2024-08-02WarningsExact identifier
application number: M006

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
106258hydrocortisone 1 % Topical CreamPSNfebcf7e8-668c-a5c9-e053-6394a90aec396
106258hydrocortisone 10 MG/ML Topical CreamSCDfebcf7e8-668c-a5c9-e053-6394a90aec396
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSYfebcf7e8-668c-a5c9-e053-6394a90aec396
106258hydrocortisone 1 % Topical CreamSYfebcf7e8-668c-a5c9-e053-6394a90aec396
106258hydrocortisone 1 GM per 100 GM Topical CreamSYfebcf7e8-668c-a5c9-e053-6394a90aec396

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
68726-504-01687260504017 g in 1 TUBE (68726-504-01) 7 g2023-07-01NoNoCurrent
68726-504-02687260504021 TUBE in 1 CARTON (68726-504-02) / 60 g in 1 TUBE1 tube2023-07-01NoNoCurrent