Home NDC 51316-165 CVS Health Maximum Strength Hydrocortisone
Product NDC 51316-165
11-digit product format 513160165
Labeler code 51316
Product ID 51316-165_6b751987-9fe6-4417-aca9-067a147cd93f
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone Ointment
Dosage form OINTMENT
Route TOPICAL
Labeler CVS Health
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-06-01
Substance HYDROCORTISONE
Active strength 10 mg/g
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 CVS Health Maximum Strength Hydrocortisone
Listing expiration 2026-12-31 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 203105 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 51316-165-28 CVS Health Maximum Strength Hydrocortisone 1 in 1 CARTON OINTMENT 1 2 51316-165-28 CVS Health Maximum Strength Hydrocortisone 28 g in 1 TUBE OINTMENT 28 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 51316-165 CVS HEALTH MAXIMUM STRENGTH HYDROCORTISONE (HYDROCORTISONE OINTMENT) OINTMENT [CVS HEALTH] 2 Current NDC, 2 package rows 20240805_ee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf3.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 Sample Exclude flag Status 51316-165-28 51316016528 1 TUBE in 1 CARTON (51316-165-28) / 28 g in 1 TUBE 1 tube 2024-06-01 No No Current