medibalm

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name medibalm
Generic Name hydrocortisone
Labeler balmrx, llc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
BalmRx, LLC

Identifiers & Regulatory

Product NDC 85529-204
Product ID 85529-204_387b74cf-5783-b70c-e063-6294a90a7248
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2025-04-21

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 85529204
Hyphenated Format 85529-204

Supplemental Identifiers

RxCUI
203105
UPC
0197644745715
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 medibalm (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 JAR in 1 BOX (85529-204-01) / 7 g in 1 JAR
source: ndc

Packages (1)

85529-204-01 1 JAR in 1 BOX (85529-204-01) / 7 g in 1 JAR

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

MediBalm ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "387b74cf-5783-b70c-e063-6294a90a7248", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0197644745715"], "unii": ["WI4X0X7BPJ"], "rxcui": ["203105"], "spl_set_id": ["324dd151-84c5-3e2f-e063-6394a90a569d"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["BalmRx, LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 JAR in 1 BOX (85529-204-01)  / 7 g in 1 JAR", "package_ndc": "85529-204-01", "marketing_start_date": "20250421"}], "brand_name": "MediBalm", "product_id": "85529-204_387b74cf-5783-b70c-e063-6294a90a7248", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "85529-204", "generic_name": "Hydrocortisone", "labeler_name": "BalmRx, LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "MediBalm", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20250421", "listing_expiration_date": "20261231"}