Home NDC 87541-031-63 Marie Originals Medicated Outdoor Anti Itch
Product NDC 87541-031
Requested package NDC 87541-031-63
11-digit product format 875410031
Labeler code 87541
Product ID 87541-031_5517ee5f-1c52-cfd6-e063-6294a90af56f
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Spray
Dosage form SPRAY
Route TOPICAL
Labeler Marie's Original Formulas, LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2026-07-10
Substance HYDROCORTISONE
Active strength 10 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Marie Originals Medicated Outdoor Anti Itch
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination WI4X0X7BPJ Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 317564 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 76 of 151 · 3,010 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 87541-031-63 87541003163 177 mL in 1 BOTTLE, SPRAY (87541-031-63) 177 ml 2026-07-10 No No Current