Home NDC 80489-001 Hydrocortisone
Product NDC 80489-001
11-digit product format 804890001
Labeler code 80489
Product ID 80489-001_48fe7e3f-613b-4f28-e063-6294a90aa4e0
Type HUMAN OTC DRUG
Nonproprietary name Drs. 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 Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 6 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2022-08-30 03:57 UTC · source 2022-08-29 excluded product product fb8cb913e6d1…eb8c232b6be0…2022-08-30 03:57 UTC · source 2022-08-29 excluded package package 80489-001-01 fb8cb913e6d1…eb8c232b6be0…2022-04-09 23:13 UTC · source 2022-04-08 excluded product product 86f5da6cb304…a595104c45d7…2022-04-09 23:13 UTC · source 2022-04-08 excluded package package 80489-001-01 86f5da6cb304…a595104c45d7…2022-04-04 05:40 UTC · source 2022-04-01 excluded product product bd6a592717d7…303034d00443…2022-04-04 05:40 UTC · source 2022-04-01 excluded package package 80489-001-01 bd6a592717d7…303034d00443…
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 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# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 80489-001-01 Hydrocortisone 28.3 g in 1 TUBE CREAM 28.3 6 80489-001-01 Hydrocortisone 1 in 1 CARTON CREAM 1 6 80489-001-02 Hydrocortisone 1 in 1 CARTON CREAM 1 6 80489-001-02 Hydrocortisone 49.5 g in 1 TUBE CREAM 49.5 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 80489-001 HYDROCORTISONE (DRS. HYDROCORTISONE) CREAM [OL PHARMA TECH,LLC] 5 Current NDC, Legacy NDC, 4 package rows 20250112_b0eac8f3-bb80-6563-e053-2995a90a83c9.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 Marketing end Sample Exclude flag Status 80489-001-01 80489000101 1 TUBE in 1 CARTON (80489-001-01) / 28.3 g in 1 TUBE 1 tube 2021-01-01 0000-00-00 No No Current 80489-001-02 80489000102 1 TUBE in 1 CARTON (80489-001-02) / 49.5 g in 1 TUBE 1 tube 2021-01-01 No No Current