Home NDC 49348-522 sunmark
Product NDC 49348-522
11-digit product format 493480522
Labeler code 49348
Product ID 49348-522_395c6919-b999-dbae-e063-6294a90af187
Type HUMAN OTC DRUG
Nonproprietary name Hydrocortisone
Dosage form OINTMENT
Route TOPICAL
Labeler Strategic Sourcing Services LLC
Application M017
Marketing category OTC MONOGRAPH DRUG
Marketing start 1989-10-03
Marketing end 2027-05-31
Substance HYDROCORTISONE
Active strength 1 g/100g
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
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 sunmark
Brand name suffix Hydrocortisone Active Ingredients# Ingredient, Strength table Ingredient Strength HYDROCORTISONE 1 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 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 49348-522-72 sunmarkHydrocortisone 1 in 1 CARTON OINTMENT 1 4 49348-522-72 sunmarkHydrocortisone 28.4 g in 1 TUBE OINTMENT 28.4 4
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-522 SUNMARK HYDROCORTISONE (HYDROCORTISONE) OINTMENT [STRATEGIC SOURCING SERVICES LLC] 3 Current NDC, Legacy NDC, 2 package rows 20241109_210079e9-3d2f-4489-b468-b96b145034ed.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 8 of 156 · 3,115 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 49348-522-72 49348052272 1 TUBE in 1 CARTON (49348-522-72) / 28.4 g in 1 TUBE 1 tube 2013-02-13 2027-05-31 No No Current