Home NDC 58790-007 TheraTears Extra
Product NDC 58790-007
11-digit product format 587900007
Labeler code 58790
Product ID 58790-007_bf94724f-8ab9-45c2-855f-b7f37e3d6504
Type HUMAN OTC DRUG
Nonproprietary name Carboxymethylcellulose Sodium, Unspecified Form
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler MEDTECH PRODUCTS INC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-04-16
Substance CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Active strength 2.5 mg/mL
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 TheraTears Extra
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination K679OBS311 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1547948 Internal RxNorm lookup 2106821 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 58790-007-15 TheraTears Extra 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 5 58790-007-15 TheraTears Extra 1 in 1 CARTON SOLUTION/ DROPS 1 5 58790-007-16 TheraTears Extra 2 in 1 CARTON SOLUTION/ DROPS 2 5 58790-007-16 TheraTears Extra 15 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 15 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58790-007 THERATEARS EXTRA (CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM) SOLUTION/ DROPS [MEDTECH PRODUCTS INC] 5 Current NDC, Legacy NDC, 4 package rows 20241212_77f504c1-b8e0-4371-ac3e-9d453d84714b.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 58790-007-15 58790000715 1 BOTTLE, DROPPER in 1 CARTON (58790-007-15) / 15 mL in 1 BOTTLE, DROPPER 2018-04-16 0000-00-00 No No Current 58790-007-16 58790000716 2 BOTTLE, DROPPER in 1 CARTON (58790-007-16) / 15 mL in 1 BOTTLE, DROPPER 2020-12-01 0000-00-00 No No Current