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 80 of 151 · 3,010 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ELAIMEI Numbing Cream LIDOCAINE 4% Shenzhen Shandian Jingling Technology Co., Ltd. 37ac13b2-ca55-0e28-e063-6294a90a000e 2025-08-19 Warnings Exact identifier application number: M017 Calamine Plus Pramoxine HCl CALAMINE PLUS SPRAY FSA Store Inc. 3cd18f96-34f7-3f2c-e063-6294a90a3b7e 2025-08-19 Warnings Exact identifier application number: M017 Hydrocortisone HYDROCORTISONE SPRAY FSA Store Inc. 3ce24b87-55ac-0bbd-e063-6294a90ab582 2025-08-19 Warnings Exact identifier application number: M017 Fast Freeze Pain Relieving MENTHOL, UNSPECIFIED FORM NATURAL ESSENTIALS, INC. 15a26af1-ca5a-40fc-a411-6c0e8ae18fbb 2025-08-18 Warnings Exact identifier application number: M017 Orythia Maximum Strength Lidocaine Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. 6d6b59f9-f614-4e3c-b07b-32b4591d39f2 2025-08-18 Warnings Exact identifier application number: M017 Ocean Potion Suncare Ice Plus Pain Relieving Soothing LIDOCAINE GNL BRANDS INTERNATIONAL, LLC 3c69654c-cba6-dfef-e063-6394a90ad479 2025-08-15 Warnings Exact identifier application number: M017 Earth Mama Medicated Herbal Lip Balm MENTHOL Eleeo Brands LLC 3c6c16bb-1f4b-b851-e063-6294a90a7404 2025-08-15 Warnings Exact identifier application number: M017 Lidocaine Hydrochloride LIDOCAINE HYDROCHLORIDE Cintas First Aid & Safety 96f17095-31f3-4b8a-ab22-0caaefaa7476 2025-08-15 Warnings Exact identifier application number: M017 MedPride Cold Ice Analgesic Gel MENTHOL SHIELD LINE LLC 860a2c86-b240-4e0e-e053-2a91aa0a333a 2025-08-15 Warnings Exact identifier application number: M017 MedPride Medicated Body Powder Powder MENTHOL, ZINC OXIDE Shield Line LLC cdb2fa5b-cf04-c876-e053-2a95a90a187c 2025-08-15 Warnings Exact identifier application number: M017 Burn LIDOCAINE HART Health c5ff392a-e788-43e0-91ea-5e0f8420586c 2025-08-15 Warnings Exact identifier application number: M017 Stopain Clinical MENTHOL Troy Manufacturing, Inc. 40df30ba-41ba-42b7-93fe-4183b57bdb00 2025-08-14 Warnings Exact identifier application number: M017 Signature Care Aloe Vera Gel with Lidocaine LIDOCAINE Safeway, Inc. d5069622-97b1-ba12-e053-2a95a90a7268 2025-08-14 Warnings Exact identifier application number: M017 METHYL SALICYLATE 25% METHYL SALICYLATE Oncora Pharma, LLC 3c4bc55d-6582-3b5e-e063-6394a90a994c 2025-08-13 Warnings Exact identifier application number: M017 Lidocaine 3% LIDOCAINE HCL 3% PureTek Corporation 3bc94d52-fe52-9fd6-e063-6294a90a4340 2025-08-12 Warnings Exact identifier application number: M017 Fast Freeze MENTHOL Natural Essentials Inc. d8c42c8d-6ce0-43bf-b165-41979f3d8f79 2025-08-12 Warnings Exact identifier application number: M017 Careland X-large Lidocaine 4 Pain Relieving LIDOCAINE Planet (Anhui) Pharmaceutical Co., Ltd. a6867506-4a46-47b1-b5b6-bfedb59dfde6 2025-08-11 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Saje Natural Business Inc. 3c194b8f-cfa5-11e3-e063-6394a90a92de 2025-08-11 Warnings Exact identifier application number: M017 Thera Plus Extra Strength Muscle Rub Topical Analgesic MENTHOL FOURSTAR GROUP USA, INC. 8a3b6adf-afbb-4d77-a19b-a6514ebd3b50 2025-08-11 Warnings Exact identifier application number: M017 EARTHS CARE ARTHRITIS CAPSAICIN DLC Laboratories, Inc. 9460674b-057e-40b9-a0f9-ca3d92068d4f 2025-08-11 Warnings Exact identifier application number: M017
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