topcare hydrocortisone

Generic: hydrocortisone

Labeler: topco associates llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name topcare hydrocortisone
Generic Name hydrocortisone
Labeler topco associates llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Topco Associates LLC

Identifiers & Regulatory

Product NDC 36800-524
Product ID 36800-524_8d4b3845-7b14-4c85-827a-cfc099de2931
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2020-02-14

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 36800524
Hyphenated Format 36800-524

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 topcare hydrocortisone (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
  • 2 TUBE in 1 CARTON (36800-524-26) / 56 g in 1 TUBE (36800-524-16)
  • 1 TUBE in 1 CARTON (36800-524-64) / 28 g in 1 TUBE
source: ndc

Packages (2)

36800-524-26 2 TUBE in 1 CARTON (36800-524-26) / 56 g in 1 TUBE (36800-524-16) 36800-524-64 1 TUBE in 1 CARTON (36800-524-64) / 28 g in 1 TUBE

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

topcare hydrocortisone ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "8d4b3845-7b14-4c85-827a-cfc099de2931", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["858053a0-d888-4bb9-b94e-503bcf3864cb"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Topco Associates LLC"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "2 TUBE in 1 CARTON (36800-524-26)  / 56 g in 1 TUBE (36800-524-16)", "package_ndc": "36800-524-26", "marketing_start_date": "20200214"}, {"sample": false, "description": "1 TUBE in 1 CARTON (36800-524-64)  / 28 g in 1 TUBE", "package_ndc": "36800-524-64", "marketing_start_date": "20200214"}], "brand_name": "topcare hydrocortisone", "product_id": "36800-524_8d4b3845-7b14-4c85-827a-cfc099de2931", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "36800-524", "generic_name": "hydrocortisone", "labeler_name": "Topco Associates LLC", "product_type": "HUMAN OTC DRUG", "brand_name_base": "topcare hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20200214", "listing_expiration_date": "20261231"}