hydrocortisone

Generic: anti itch

Labeler: neilmed pharmaceuticals inc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name anti itch
Labeler neilmed pharmaceuticals inc
Dosage Form OINTMENT
Routes
TOPICAL
Active Ingredients

hydrocortisone .0102 g/g

Manufacturer
NeilMed Pharmaceuticals Inc

Identifiers & Regulatory

Product NDC 13709-316
Product ID 13709-316_1ce22733-8f6f-d7ea-e063-6294a90aa49b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-08-17

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 13709316
Hyphenated Format 13709-316

Supplemental Identifiers

UPC
0705928150010
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 hydrocortisone (source: ndc)
Generic Name anti itch (source: ndc)
Application Number M017 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • .0102 g/g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (13709-316-01) / 28 g in 1 TUBE
source: ndc

Packages (1)

13709-316-01 1 TUBE in 1 CARTON (13709-316-01) / 28 g in 1 TUBE

Ingredients (1)

hydrocortisone (.0102 g/g)

Linked Drug Pages (1)

Hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "1ce22733-8f6f-d7ea-e063-6294a90aa49b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0705928150010"], "unii": ["WI4X0X7BPJ"], "spl_set_id": ["031957e1-9b0c-1579-e063-6394a90aaee8"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["NeilMed Pharmaceuticals Inc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (13709-316-01)  / 28 g in 1 TUBE", "package_ndc": "13709-316-01", "marketing_start_date": "20230817"}], "brand_name": "Hydrocortisone", "product_id": "13709-316_1ce22733-8f6f-d7ea-e063-6294a90aa49b", "dosage_form": "OINTMENT", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "13709-316", "generic_name": "Anti Itch", "labeler_name": "NeilMed Pharmaceuticals Inc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": ".0102 g/g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230817", "listing_expiration_date": "20261231"}