Home NDC 51672-2010 Hydrocortisone
Product NDC 51672-2010
11-digit product format 516722010
Labeler code 51672
Product ID 51672-2010_390d0eb8-c4dc-e391-e063-6394a90a7333
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler Sun Pharmaceutical Industries, Inc.
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2001-09-13
Substance HYDROCORTISONE
Active strength .5 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
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 Hydrocortisone
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE .5 g/100g
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 198707 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 51672-2010-2 Hydrocortisone 1 in 1 CARTON CREAM 1 4 51672-2010-2 Hydrocortisone 28.4 g in 1 TUBE CREAM 28.4 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Hydrocortisone ACTIVE INGREDIENT WI4X0X7BPJ HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 Hydrocortisone ACTIVE MOIETY WI4X0X7BPJ HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 cetostearyl alcohol INACTIVE INGREDIENT 2DMT128M1S HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 citric acid monohydrate INACTIVE INGREDIENT 2968PHW8QP HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 glycerin INACTIVE INGREDIENT PDC6A3C0OX HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 glyceryl monostearate INACTIVE INGREDIENT 230OU9XXE4 HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 methylparaben INACTIVE INGREDIENT A2I8C7HI9T HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 mineral oil INACTIVE INGREDIENT T5L8T28FGP HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 paraffin INACTIVE INGREDIENT I9O0E3H2ZE HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 propylparaben INACTIVE INGREDIENT Z8IX2SC1OH HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 sodium cetostearyl sulfate INACTIVE INGREDIENT 7ZBS06BH4B HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 sodium lauryl sulfate INACTIVE INGREDIENT 368GB5141J HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 stearyl alcohol INACTIVE INGREDIENT 2KR89I4H1Y HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1 water INACTIVE INGREDIENT 059QF0KO0R HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51672-2010 HYDROCORTISONE CREAM [TARO PHARMACEUTICALS U.S.A., INC.] 3 Current NDC, Legacy NDC, 2 package rows 20241222_2ada9ec2-1c28-4da2-8639-07b3193ffb32.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 81 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PROHEAL HYDROCORTISONE 1% MAXIMUM STRENGTH PLUS ALOE HYDROCORTISONE Click Industries LLC 328c389c-7e05-4892-a9b3-b6a753f4935a 2025-08-25 Warnings Exact identifier application number: M017 Yeheal CAMPHOR, MENTHOL, ISOPROPYL ALCOHOL Shenzhen Yeheal Biotechnology Co., Ltd 3cf1bc74-3060-6d63-e063-6294a90a9f5c 2025-08-22 Warnings Exact identifier application number: M017 Dermedial Anti-Ouch MENTHOL Natures Formulae Health Products Ltd. 3ce29160-3964-e435-e063-6394a90abb38 2025-08-21 Warnings Exact identifier application number: M017 SUGARLOAF ORGANICS MENTHOL REVIVE MENTHOL RENU LABORATORIES, LLC fa2f9539-b703-a00b-e053-6394a90ae309 2025-08-21 Warnings Exact identifier application number: M017 Camphor 4% Plus Menthol 10% CAMPHOR 4% PLUS MENTHOL 10% PureTek Corporation 3cab26e4-e377-f26a-e063-6394a90a17af 2025-08-20 Warnings Exact identifier application number: M017 Capsaicin 0.035% Cream CAPSAICIN 0.035% CREAM Puretekcorp 3cbc73b6-8c58-8f23-e063-6394a90a71a3 2025-08-20 Warnings Exact identifier application number: M017 Game On MENTHOL, METHYL SALICYLATE Natural Essentials, Inc. 3cd20f1f-033f-f698-e063-6294a90a89eb 2025-08-20 Warnings Exact identifier application number: M017 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
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 51672-2010-2 51672201002 1 TUBE in 1 CARTON (51672-2010-2) / 28.4 g in 1 TUBE 1 tube 2001-09-13 0000-00-00 No No Current