TheraTears
- Product NDC
- 58790-003
- 11-digit product format
- 587900003
- Labeler code
- 58790
- Product ID
- 58790-003_87b4fa69-d73c-46d8-9083-cf2b2eddd5e3
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- carboxymethylcellulose sodium
- Dosage form
- GEL
- Route
- OPHTHALMIC
- Labeler
- MEDTECH PRODUCTS INC
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2018-12-07
- Substance
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
- Active strength
- 10 mg/mL
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- TheraTears
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM | 10 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | K679OBS311 |
| Rxcui | 579907, 998666 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 58790-003-30 | TheraTears | 5 in 1 POUCH | GEL | 5 | | 11 |
| 58790-003-30 | TheraTears | 6 in 1 CARTON | GEL | 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 |
|---|
| 58790-003 | THERATEARS (CARBOXYMETHYLCELLULOSE SODIUM) GEL [MEDTECH PRODUCTS INC] | 10 | Current NDC, Legacy NDC, 2 package rows | 20241212_17a01236-130f-495b-9f8d-92b6a23b2dc5.zip |
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 |
|---|
| 58790-003-30 | 58790000330 | 6 POUCH in 1 CARTON (58790-003-30) / 5 VIAL in 1 POUCH / .6 mL in 1 VIAL | 6 pouch | 2018-12-07 | 0000-00-00 | No | No | Current |