Optic Splash
- Product NDC
- 49873-501
- 11-digit product format
- 498730501
- Labeler code
- 49873
- Product ID
- 49873-501_b7c12f8f-0494-7d53-e053-2a95a90ae02e
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- naphazoline hydrochloride, glycerin
- Dosage form
- SOLUTION/ DROPS
- Route
- OPHTHALMIC
- Labeler
- Sato Pharmaceutical, Co., Ltd.
- Application
- part349
- Marketing category
- OTC MONOGRAPH FINAL
- Marketing start
- 2008-01-22
- Marketing end
- 0000-00-00
- Substance
- NAPHAZOLINE HYDROCHLORIDE; GLYCERIN
- Active strength
- 20 mg/100mL; mg/100mL
- NDC exclude flag
- No
- Listing certified through
- 2021-12-31
- Current FDA listing
- Historical FDA.report record
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| GLYCERIN | ACTIVE INGREDIENT | PDC6A3C0OX | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| NAPHAZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | MZ1131787D | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| GLYCERIN | ACTIVE MOIETY | PDC6A3C0OX | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| NAPHAZOLINE | ACTIVE MOIETY | H231GF11BV | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| CAMPHOR (SYNTHETIC) | INACTIVE INGREDIENT | 5TJD82A1ET | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| LEVOMENTHOL | INACTIVE INGREDIENT | BZ1R15MTK7 | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| POTASSIUM CHLORIDE | INACTIVE INGREDIENT | 660YQ98I10 | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| SODIUM CHLORIDE | INACTIVE INGREDIENT | 451W47IQ8X | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 1 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 49873-501 | OPTIC SPLASH (NAPHAZOLINE HYDROCHLORIDE, GLYCERIN) SOLUTION/ DROPS [SATO PHARMACEUTICAL, CO., LTD.] | 4 | Legacy NDC | 20231205_e3d60c20-7cbc-4728-8e42-441b64608b88.zip |
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 49873-501-01 | 49873050101 | 1 BOTTLE in 1 CARTON (49873-501-01) > 15 mL in 1 BOTTLE | 1 bottle | 2008-01-22 | 0000-00-00 | No | No | Current |