Home NDC 58790-002 TheraTears
Product NDC 58790-002
11-digit product format 587900002
Labeler code 58790
Product ID 58790-002_7fa25608-0b89-4e34-a2d8-1e64b46db208
Type HUMAN OTC DRUG
Nonproprietary name carboxymethylcellulose sodium
Dosage form GEL
Route OPHTHALMIC
Labeler MEDTECH PRODUCTS INC
Application part349
Marketing category OTC MONOGRAPH FINAL
Marketing start 2002-12-01
Marketing end 0000-00-00
Substance CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
Active strength 10 mg/mL
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 58790-002-28 TheraTears 7 in 1 CARTON GEL 7 11 58790-002-28 TheraTears 0.6 mL in 1 POUCH GEL 0.6 11
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded carboxymethylcellulose sodium ACTIVE INGREDIENT K679OBS311 THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 carboxymethylcellulose ACTIVE MOIETY 05JZI7B19X THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 boric acid INACTIVE INGREDIENT R57ZHV85D4 THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 calcium chloride INACTIVE INGREDIENT M4I0D6VV5M THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 magnesium chloride INACTIVE INGREDIENT 02F3473H9O THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 potassium chloride INACTIVE INGREDIENT 660YQ98I10 THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 sodium bicarbonate INACTIVE INGREDIENT 8MDF5V39QO THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 sodium borate INACTIVE INGREDIENT 91MBZ8H3QO THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 sodium chloride INACTIVE INGREDIENT 451W47IQ8X THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 sodium phosphate INACTIVE INGREDIENT SE337SVY37 THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1 water INACTIVE INGREDIENT 059QF0KO0R THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [ADVANCED VISION RESEARCH (SUBSIDIARY OF AKORN, INC.)] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 58790-002 THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [MEDTECH PRODUCTS INC] 10 Legacy NDC, 2 package rows 20241212_17a01236-130f-495b-9f8d-92b6a23b2dc5.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 1 of 1 · 1 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 58790-002-28 58790000228 7 POUCH in 1 CARTON (58790-002-28) > .6 mL in 1 POUCH 7 pouch 2002-12-01 0000-00-00 No No Current