anti itch

Generic: hydrocortisone

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

Drug Facts

Product Profile

Brand Name anti itch
Generic Name hydrocortisone
Labeler neilmed pharmaceuticals inc.
Dosage Form GEL
Routes
RECTAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Neilmed Pharmaceuticals Inc.

Identifiers & Regulatory

Product NDC 13709-326
Product ID 13709-326_14b4f066-fde5-ac97-e063-6394a90ae64c
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2024-05-21

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 13709326
Hyphenated Format 13709-326

Supplemental Identifiers

UPC
0705928160019
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 anti itch (source: ndc)
Generic Name hydrocortisone (source: ndc)
Application Number M017 (source: ndc)
Routes
RECTAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 1 TUBE in 1 CARTON (13709-326-01) / 28.3 g in 1 TUBE
source: ndc

Packages (1)

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["RECTAL"], "spl_id": "14b4f066-fde5-ac97-e063-6394a90ae64c", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0705928160019"], "unii": ["WI4X0X7BPJ"], "spl_set_id": ["14b4f066-fde4-ac97-e063-6394a90ae64c"], "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 (13709-326-01)  / 28.3 g in 1 TUBE", "package_ndc": "13709-326-01", "marketing_start_date": "20240521"}], "brand_name": "Anti Itch", "product_id": "13709-326_14b4f066-fde5-ac97-e063-6394a90ae64c", "dosage_form": "GEL", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "13709-326", "generic_name": "Hydrocortisone", "labeler_name": "Neilmed Pharmaceuticals Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti Itch", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20240521", "listing_expiration_date": "20261231"}