Home NDC 49348-037 Sunmark Eye Drops Original Formula
Product NDC 49348-037
11-digit product format 493480037
Labeler code 49348
Product ID 49348-037_0d295927-09c8-5b68-e063-6394a90a965f
Type HUMAN OTC DRUG
Nonproprietary name Tetrahydrozoline HCl
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Strategic Sourcing Services LLC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2007-03-01
Substance TETRAHYDROZOLINE HYDROCHLORIDE
Active strength .05 g/100mL
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 Sunmark Eye Drops Original Formula
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength TETRAHYDROZOLINE HYDROCHLORIDE .05 g/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 0YZT43HS7D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1052943 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 49348-037-29 Sunmark Eye Drops Original Formula 15 mL in 1 BOTTLE, PLASTIC SOLUTION/ DROPS 15 5 49348-037-29 Sunmark Eye Drops Original Formula 1 in 1 CARTON SOLUTION/ DROPS 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49348-037 SUNMARK EYE DROPS ORIGINAL FORMULA (TETRAHYDROZOLINE HCL) SOLUTION/ DROPS [STRATEGIC SOURCING SERVICES LLC] 5 Current NDC, Legacy NDC, 2 package rows 20240103_33efa7e9-4c3a-4d72-af31-c5e35095c2ff.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 6 of 25 · 494 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 49348-037-29 49348003729 1 BOTTLE, PLASTIC in 1 CARTON (49348-037-29) / 15 mL in 1 BOTTLE, PLASTIC 2007-03-01 0000-00-00 No No Current