LEADER ORIGINAL FORMULA EYE DROPS
- Product NDC
- 11716-4708
- 11-digit product format
- 117164708
- Labeler code
- 11716
- Product ID
- 11716-4708_312b0852-6077-491f-ae04-3a079d9bb885
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- TETRAHYDROZOLINE HYDROCHLORIDE
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- HANLIM PHARM. CO., LTD.
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2010-03-22
- Marketing end
- 0000-00-00
- Substance
- TETRAHYDROZOLINE HYDROCHLORIDE
- Active strength
- 1 mg/mL
- DEA schedule
- CIV
- NDC exclude flag
- E
- Listing certified through
- 2018-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Product Concepts#
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 27945931-b6e2-158e-d615-4ef21e2af974 | Product name | 1 | 20140508 |
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 11716-4708-8 | 2020-01-31 | C162847 | 48780-1 | 9d75b9d0-a351-f424-e053-dadaa90a57ce | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 11716-4708-8 | LEADER ORIGINAL FORMULA EYE DROPS | 15 mL in 1 BOTTLE | SOLUTION/ DROPS | 15 | 5 | |
| 11716-4708-8 | LEADER ORIGINAL FORMULA EYE DROPS | 1 in 1 CARTON | SOLUTION/ DROPS | 1 | 5 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|---|---|---|---|---|
| TETRAHYDROZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | 0YZT43HS7D | LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 5 | |
| TETRAHYDROZOLINE | ACTIVE MOIETY | S9U025Y077 | LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 5 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 5 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 5 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 5 |
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 11716-4708 | LEADER ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HYDROCHLORIDE) SOLUTION/ DROPS [HANLIM PHARM. CO., LTD.] | 5 | Legacy NDC, 2 package rows | 20100405_c815b41d-811f-4e4c-929a-383727074f91.zip |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 1052943 | tetrahydrozoline HCl 0.05 % Ophthalmic Solution | PSN | c815b41d-811f-4e4c-929a-383727074f91 | 5 |
| 1052943 | tetrahydrozoline hydrochloride 0.5 MG/ML Ophthalmic Solution | SCD | c815b41d-811f-4e4c-929a-383727074f91 | 5 |
| 1052943 | tetrahydrozoline hydrochloride 0.05 % Eye Drops | SY | c815b41d-811f-4e4c-929a-383727074f91 | 5 |
| 1052943 | tetrahydrozoline hydrochloride 0.05 % Ophthalmic Solution | SY | c815b41d-811f-4e4c-929a-383727074f91 | 5 |
Packages#
| Package NDC | 11-digit format | Description | Units | Status |
|---|---|---|---|---|
| 11716-4708-8 | 11716470808 | 15 mL in 1 BOTTLE | 15 ml | Historical |