pediadermics eczema 2

Generic: hydrocortisone

Labeler: renu laboratories, llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name pediadermics eczema 2
Generic Name hydrocortisone
Labeler renu laboratories, llc
Dosage Form SPRAY
Routes
TOPICAL
Active Ingredients

hydrocortisone 1.12 g/112g

Manufacturer
RENU LABORATORIES, LLC

Identifiers & Regulatory

Product NDC 76348-585
Product ID 76348-585_44fb0779-2a64-f2a5-e063-6294a90a33d1
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2022-03-18

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 76348585
Hyphenated Format 76348-585

Supplemental Identifiers

RxCUI
317564
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 pediadermics eczema 2 (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1.12 g/112g
source: ndc
Packaging
  • 112 g in 1 BOTTLE, SPRAY (76348-585-04)
source: ndc

Packages (1)

76348-585-04 112 g in 1 BOTTLE, SPRAY (76348-585-04)

Ingredients (1)

hydrocortisone (1.12 g/112g)

Linked Drug Pages (1)

PEDIADERMICS ECZEMA 2 ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "44fb0779-2a64-f2a5-e063-6294a90a33d1", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["317564"], "spl_set_id": ["da840bf6-ed65-bafc-e053-2a95a90a92d5"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["RENU LABORATORIES, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "112 g in 1 BOTTLE, SPRAY (76348-585-04)", "package_ndc": "76348-585-04", "marketing_start_date": "20220318"}], "brand_name": "PEDIADERMICS ECZEMA 2", "product_id": "76348-585_44fb0779-2a64-f2a5-e063-6294a90a33d1", "dosage_form": "SPRAY", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "76348-585", "generic_name": "Hydrocortisone", "labeler_name": "RENU LABORATORIES, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "PEDIADERMICS ECZEMA 2", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1.12 g/112g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20220318", "listing_expiration_date": "20261231"}