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 150 of 153 · 3,057 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join DIRT Pain Relieving Gel MENTHOL PURIVITAE, LLC e43e2cbd-d114-4b11-8baf-7a775881cd97 2023-11-06 Warnings Exact identifier application number: M017 Celadrin Joint and Muscle Pain Relieving MENTHOL Factors Group of Nutritional Products 6396e4b6-2130-433b-bdb3-97c76dbe685c 2023-11-06 Warnings Exact identifier application number: M017 Atomic Balm METHYL SALICYLATE, CAPSAICIN The Hygenic Company, LLC d10028f3-ae6a-7b01-e053-2995a90a5a84 2023-11-05 Warnings Exact identifier application number: M017 HEMPCIN Advanced Topical Pain Relief Cream MENTHOL Pedicis Research, LLC 97f5e300-b780-4694-a681-60d5e0cfad65 2023-11-05 Warnings Exact identifier application number: M017 Point Relief cold Spot Pain Relieving roll-on MENTHOL Fabrication Enterprises 3f1db0ad-aaa8-4e14-9349-45057e0fb4a6 2023-11-05 Warnings Exact identifier application number: M017 LidoStat LIDOCAINE HCL Clinical Therapeutic Solutions 1825885b-9141-4515-bb69-a1c4a39fb10d 2023-11-05 Warnings Exact identifier application number: M017 Point Relief Cold Spot Pain Relieving MENTHOL Fabrication Enterprises 391af69f-74aa-48cf-bc96-75e5c4e0e445 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS NATURAL PAIN MENTHOL The Feel Good Lab 778b62a1-ebd3-4a30-8f76-6d6773b698c5 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL The Feel Good Lab 103c5e33-42fb-41ac-957e-bb46d85e204c 2023-11-05 Warnings Exact identifier application number: M017 INSTA RELIEF DM LIDOCAINE HYDROCHLORIDE, MENTHOL DM LAB CORP 6ef66fb9-9f49-409d-9503-175c7555ee9e 2023-11-05 Warnings Exact identifier application number: M017 DR. MIKES Ponos Pain Relief Cream Roll-On HISTAMINE DIHYDROCHLORIDE, MENTHOL Dr. Mike's Vitamins, LLC fcc45464-f1fe-4244-95a7-9b4288b0ce45 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Pain Relief MENTHOL Innovations for Wellness, LLC 7f222a4f-85a8-4f3d-aa97-5c695d4da37f 2023-11-05 Warnings Exact identifier application number: M017 Ana Cool Rapid Soothing Cooling Formula HYDROCORTISONE Ana-Cool, LLC 64b80cc2-e2d8-4535-aaf8-c031f4159cd1 2023-11-05 Warnings Exact identifier application number: M017 FEEL GOOD LABS SPORT RECOVERY MENTHOL THE FEEL GOOD LAB, LLC 19b08cbf-5f43-4f07-8f4d-8cddb1492ab8 2023-11-05 Warnings Exact identifier application number: M017 PlayMakar Roll On Cool Pain Relief MENTHOL PlayMakar Inc. a12c16e7-561f-45a7-93c6-34d693ffdc7c 2023-11-05 Warnings Exact identifier application number: M017 AcuPlus Advanced Therapy for Pain and Recovery MENTHOL INNOVATIONS FOR WELLNESS, LLC 840cfd15-4ea1-49bf-8c4f-86c12461d860 2023-11-05 Warnings Exact identifier application number: M017 SCLERA CARE Topical Anesthetic Gel LIDOCAINE HYDROCHLORIDE ScleraCare, LLC 488ace02-fc0b-4d13-ab89-0e1640e915e5 2023-11-05 Warnings Exact identifier application number: M017 IRELIEV ROLL ON COOL PAIN RELIEF MENTHOL Excel Health, Inc dab94995-7393-4d9c-b295-72611a90919b 2023-11-05 Warnings Exact identifier application number: M017 URIFLEX Fast Acting Analgesic Pain Relief MENTHOL Rejuvica LLC fb78f705-b838-461d-b42c-8c98d3ca5d09 2023-11-05 Warnings Exact identifier application number: M017 365 Medicated Lip Balm MEDICATED LIP BALM Whole Foods Market, Inc. 48309a7d-d2da-483c-8bf8-f59d9ad0bb73 2023-11-03 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