clinicalm

Generic: hydrocortisone

Labeler: cp skin health group, inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name clinicalm
Generic Name hydrocortisone
Labeler cp skin health group, inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
CP Skin Health Group, Inc.

Identifiers & Regulatory

Product NDC 68726-504
Product ID 68726-504_2865dbce-02f6-ebe7-e063-6294a90ab3cb
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M006
Listing Expiration 2026-12-31
Marketing Start 2023-07-01

Pharmacologic Class

Established (EPC)
corticosteroid [epc]
Mechanism of Action
corticosteroid hormone receptor agonists [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 68726504
Hyphenated Format 68726-504

Supplemental Identifiers

RxCUI
106258
UNII
WI4X0X7BPJ
NUI
N0000175576 N0000175450

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name clinicalm (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M006 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 7 g in 1 TUBE (68726-504-01)
  • 1 TUBE in 1 CARTON (68726-504-02) / 60 g in 1 TUBE
source: ndc

Packages (2)

68726-504-01 7 g in 1 TUBE (68726-504-01) 68726-504-02 1 TUBE in 1 CARTON (68726-504-02) / 60 g in 1 TUBE

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

CliniCalm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "2865dbce-02f6-ebe7-e063-6294a90ab3cb", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["febcf7e8-668c-a5c9-e053-6394a90aec39"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["CP Skin Health Group, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "7 g in 1 TUBE (68726-504-01)", "package_ndc": "68726-504-01", "marketing_start_date": "20230701"}, {"sample": false, "description": "1 TUBE in 1 CARTON (68726-504-02)  / 60 g in 1 TUBE", "package_ndc": "68726-504-02", "marketing_start_date": "20230701"}], "brand_name": "CliniCalm", "product_id": "68726-504_2865dbce-02f6-ebe7-e063-6294a90ab3cb", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "68726-504", "generic_name": "Hydrocortisone", "labeler_name": "CP Skin Health Group, Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "CliniCalm", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M006", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230701", "listing_expiration_date": "20261231"}