hydrocortisone

Generic: antipruritic (anti-itch)

Labeler: dynarex corporation
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone
Generic Name antipruritic (anti-itch)
Labeler dynarex corporation
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Dynarex Corporation

Identifiers & Regulatory

Product NDC 67777-004
Product ID 67777-004_0fa32e68-a566-6d7e-e063-6394a90af08b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M032
Listing Expiration 2026-12-31
Marketing Start 2021-03-25

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 67777004
Hyphenated Format 67777-004

Supplemental Identifiers

RxCUI
106258
UPC
0616784113920 0616784113722 0840117328174 0840117328198
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 antipruritic (anti-itch) (source: ndc)
Application Number M032 (source: ndc)
Routes
TOPICAL
source: ndc

Resolved Composition

Strengths
  • 1 g/100g
source: ndc
Packaging
  • 72 BOX in 1 CASE (67777-004-01) / 1 TUBE in 1 BOX (67777-004-02) / 28.4 g in 1 TUBE
  • 12 BOX in 1 CASE (67777-004-04) / 144 PACKET in 1 BOX (67777-004-03) / .9 g in 1 PACKET
  • 600 BOX in 1 CASE (67777-004-05) / 6 PACKET in 1 BOX (67777-004-06) / .9 g in 1 PACKET
  • 1800 BOX in 1 CASE (67777-004-07) / 25 PACKET in 1 BOX (67777-004-08) / .9 g in 1 PACKET
source: ndc

Packages (4)

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Raw FDA Data

View complete raw FDA NDC JSON payload
{"route": ["TOPICAL"], "spl_id": "0fa32e68-a566-6d7e-e063-6394a90af08b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0616784113920", "0616784113722", "0840117328174", "0840117328198"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["81dff9df-6f7e-49f0-e053-2a91aa0af7e7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Dynarex Corporation"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "72 BOX in 1 CASE (67777-004-01)  / 1 TUBE in 1 BOX (67777-004-02)  / 28.4 g in 1 TUBE", "package_ndc": "67777-004-01", "marketing_start_date": "20210325"}, {"sample": false, "description": "12 BOX in 1 CASE (67777-004-04)  / 144 PACKET in 1 BOX (67777-004-03)  / .9 g in 1 PACKET", "package_ndc": "67777-004-04", "marketing_start_date": "20210325"}, {"sample": false, "description": "600 BOX in 1 CASE (67777-004-05)  / 6 PACKET in 1 BOX (67777-004-06)  / .9 g in 1 PACKET", "package_ndc": "67777-004-05", "marketing_start_date": "20210325"}, {"sample": false, "description": "1800 BOX in 1 CASE (67777-004-07)  / 25 PACKET in 1 BOX (67777-004-08)  / .9 g in 1 PACKET", "package_ndc": "67777-004-07", "marketing_start_date": "20210325"}], "brand_name": "Hydrocortisone", "product_id": "67777-004_0fa32e68-a566-6d7e-e063-6394a90af08b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "67777-004", "generic_name": "Antipruritic (Anti-Itch)", "labeler_name": "Dynarex Corporation", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M032", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210325", "listing_expiration_date": "20261231"}