hydrocortisone 1%

Generic: hydrocortisone

Labeler: trifecta pharmaceuticals usa llc
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name hydrocortisone 1%
Generic Name hydrocortisone
Labeler trifecta pharmaceuticals usa llc
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Trifecta Pharmaceuticals Usa Llc

Identifiers & Regulatory

Product NDC 69396-118
Product ID 69396-118_4c35f112-b0b8-2efb-e063-6394a90a8f5b
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2027-12-31
Marketing Start 2023-05-31

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 69396118
Hyphenated Format 69396-118

Supplemental Identifiers

RxCUI
106258
UPC
0850026393767
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 1% (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
  • 144 PACKET in 1 CARTON (69396-118-09) / .9 g in 1 PACKET
  • 25 PACKET in 1 BOX (69396-118-25) / .9 g in 1 PACKET
source: ndc

Packages (2)

69396-118-09 144 PACKET in 1 CARTON (69396-118-09) / .9 g in 1 PACKET 69396-118-25 25 PACKET in 1 BOX (69396-118-25) / .9 g in 1 PACKET

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Hydrocortisone 1% ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "4c35f112-b0b8-2efb-e063-6394a90a8f5b", "openfda": {"nui": ["N0000175576", "N0000175450"], "upc": ["0850026393767"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["f4d4a56b-b4b7-9a07-e053-2a95a90ad853"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Trifecta Pharmaceuticals Usa Llc"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "144 PACKET in 1 CARTON (69396-118-09)  / .9 g in 1 PACKET", "package_ndc": "69396-118-09", "marketing_start_date": "20230531"}, {"sample": false, "description": "25 PACKET in 1 BOX (69396-118-25)  / .9 g in 1 PACKET", "package_ndc": "69396-118-25", "marketing_start_date": "20230531"}], "brand_name": "Hydrocortisone 1%", "product_id": "69396-118_4c35f112-b0b8-2efb-e063-6394a90a8f5b", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "69396-118", "generic_name": "Hydrocortisone", "labeler_name": "Trifecta Pharmaceuticals Usa Llc", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Hydrocortisone 1%", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230531", "listing_expiration_date": "20271231"}