Home NDC 80489-088 Drs. Hydrocortisone Aloe Vera
Product NDC 80489-088
11-digit product format 804890088
Labeler code 80489
Product ID 80489-088_56369475-40fb-74e4-e063-6394a90a7a7e
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form CREAM
Route TOPICAL
Labeler OL PHARMA TECH,LLC
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2021-01-01
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 Drs. Hydrocortisone Aloe Vera
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# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-088-01 Drs. Hydrocortisone Aloe Vera 28.3 g in 1 TUBE CREAM 28.3 1 80489-088-01 Drs. Hydrocortisone Aloe Vera 1 in 1 CARTON CREAM 1 1 80489-088-02 Drs. Hydrocortisone Aloe Vera 1 in 1 CARTON CREAM 1 1 80489-088-02 Drs. Hydrocortisone Aloe Vera 49.5 g in 1 TUBE CREAM 49.5 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-088 DRS. HYDROCORTISONE ALOE VERA (HYDROCORTISONE) CREAM [OL PHARMA TECH,LLC] 1 Current NDC, 4 package rows 20240102_0df06415-5d32-7ef8-e063-6294a90a6e5a.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 28 of 68 · 1,357 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 80489-088-01 80489008801 1 TUBE in 1 CARTON (80489-088-01) / 28.3 g in 1 TUBE 1 tube 2021-01-01 No No Current 80489-088-02 80489008802 1 TUBE in 1 CARTON (80489-088-02) / 49.5 g in 1 TUBE 1 tube 2021-01-01 No No Current