anti-itch paraben free

Generic: hydrocortisone

Labeler: weeks & leo co., inc.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name anti-itch paraben free
Generic Name hydrocortisone
Labeler weeks & leo co., inc.
Dosage Form CREAM
Routes
TOPICAL
Active Ingredients

hydrocortisone 1 g/100g

Manufacturer
Weeks & Leo Co., Inc.

Identifiers & Regulatory

Product NDC 11383-313
Product ID 11383-313_0c5419c5-0928-7ca6-e063-6294a90ac0a7
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M017
Listing Expiration 2026-12-31
Marketing Start 2023-03-03

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 11383313
Hyphenated Format 11383-313

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 anti-itch paraben free (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
  • 1 TUBE in 1 CARTON (11383-313-01) / 28 g in 1 TUBE
  • 1 TUBE in 1 CARTON (11383-313-02) / 56 g in 1 TUBE
source: ndc

Packages (2)

11383-313-01 1 TUBE in 1 CARTON (11383-313-01) / 28 g in 1 TUBE 11383-313-02 1 TUBE in 1 CARTON (11383-313-02) / 56 g in 1 TUBE

Ingredients (1)

hydrocortisone (1 g/100g)

Linked Drug Pages (1)

Anti-itch Paraben Free ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["TOPICAL"], "spl_id": "0c5419c5-0928-7ca6-e063-6294a90ac0a7", "openfda": {"nui": ["N0000175576", "N0000175450"], "unii": ["WI4X0X7BPJ"], "rxcui": ["106258"], "spl_set_id": ["0c5419c5-0929-7ca6-e063-6294a90ac0a7"], "pharm_class_epc": ["Corticosteroid [EPC]"], "pharm_class_moa": ["Corticosteroid Hormone Receptor Agonists [MoA]"], "manufacturer_name": ["Weeks & Leo Co., Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 TUBE in 1 CARTON (11383-313-01)  / 28 g in 1 TUBE", "package_ndc": "11383-313-01", "marketing_start_date": "20230303"}, {"sample": false, "description": "1 TUBE in 1 CARTON (11383-313-02)  / 56 g in 1 TUBE", "package_ndc": "11383-313-02", "marketing_start_date": "20230303"}], "brand_name": "Anti-itch Paraben Free", "product_id": "11383-313_0c5419c5-0928-7ca6-e063-6294a90ac0a7", "dosage_form": "CREAM", "pharm_class": ["Corticosteroid Hormone Receptor Agonists [MoA]", "Corticosteroid [EPC]"], "product_ndc": "11383-313", "generic_name": "HYDROCORTISONE", "labeler_name": "Weeks & Leo Co., Inc.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Anti-itch Paraben Free", "active_ingredients": [{"name": "HYDROCORTISONE", "strength": "1 g/100g"}], "application_number": "M017", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20230303", "listing_expiration_date": "20261231"}