Home NDC 53329-091 Anti-itch
Product NDC 53329-091
11-digit product format 533290091
Labeler code 53329
Product ID 53329-091_40c054e1-8661-4940-e063-6294a90a0200
Type HUMAN OTC DRUG
Nonproprietary name hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Medline Industries, LP
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2010-03-01
Substance HYDROCORTISONE
Active strength 10 mg/g
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 Anti-itch
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 10 mg/g
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 106258 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded HYDROCORTISONE ACTIVE INGREDIENT WI4X0X7BPJ ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 HYDROCORTISONE ACTIVE MOIETY WI4X0X7BPJ ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 CITRIC ACID MONOHYDRATE INACTIVE INGREDIENT 2968PHW8QP ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 GLYCERYL STEARATE CITRATE INACTIVE INGREDIENT WH8T92A065 ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 METHYLPARABEN INACTIVE INGREDIENT A2I8C7HI9T ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 PETROLATUM INACTIVE INGREDIENT 4T6H12BN9U ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 POLYSORBATE 80 INACTIVE INGREDIENT 6OZP39ZG8H ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 PROPYLENE GLYCOL INACTIVE INGREDIENT 6DC9Q167V3 ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 PROPYLPARABEN INACTIVE INGREDIENT Z8IX2SC1OH ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 SODIUM CITRATE INACTIVE INGREDIENT 1Q73Q2JULR ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 TITANIUM DIOXIDE INACTIVE INGREDIENT 15FIX9V2JP ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6 WATER INACTIVE INGREDIENT 059QF0KO0R ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, INC.] 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-091 ANTI-ITCH (HYDROCORTISONE) CREAM [MEDLINE INDUSTRIES, LP] 13 Current NDC, Legacy NDC, 6 package rows 20250112_b0947381-c0db-4253-ab40-3d45603ae65d.zip
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 18 of 153 · 3,057 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-091-01 53329009101 1 TUBE in 1 BOX (53329-091-01) / 28.4 g in 1 TUBE 1 tube 2010-03-01 0000-00-00 No No Current 53329-091-90 53329009190 1.5 g in 1 PACKET (53329-091-90) 1.5 g 2010-03-01 0000-00-00 No No Current 53329-091-91 53329009191 48 PACKET in 1 CARTON (53329-091-91) / 1.5 g in 1 PACKET (53329-091-90) 48 packet 2010-03-01 0000-00-00 No No Current 53329-091-96 53329009196 144 TUBE in 1 CASE (53329-091-96) / 28.4 g in 1 TUBE 144 tube 2010-03-01 0000-00-00 No No Current