Rohto
- Product NDC
- 10742-8142
- 11-digit product format
- 107428142
- Labeler code
- 10742
- Product ID
- 10742-8142_2978e70a-6498-3b0d-e063-6394a90a88fd
- Type
- HUMAN OTC DRUG
- Nonproprietary name
- Naphazoline hydrochloride, Polysorbate 80
- Dosage form
- LIQUID
- Route
- OPHTHALMIC
- Labeler
- The Mentholatum Company
- Application
- M018
- Marketing category
- OTC MONOGRAPH DRUG
- Marketing start
- 2001-08-21
- Substance
- NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
- Active strength
- .12; 2 mg/mL; 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
- Rohto
- Brand name suffix
- Cool
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPHAZOLINE HYDROCHLORIDE | .12 mg/mL |
| POLYSORBATE 80 | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MZ1131787D, 6OZP39ZG8H |
| Rxcui | 1098362 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 10742-8142-1 | RohtoCool | 1 in 1 CARTON | LIQUID | 1 | | 15 |
| 10742-8142-1 | RohtoCool | 13 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 13 | | 15 |
DailyMed Socrata Ingredients#
Ingredient, Type, UNII table| Ingredient | Type | UNII | DailyMed label | SPL version | Uploaded |
|---|
| NAPHAZOLINE HYDROCHLORIDE | ACTIVE INGREDIENT | MZ1131787D | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| POLYSORBATE 80 | ACTIVE INGREDIENT | 6OZP39ZG8H | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| NAPHAZOLINE | ACTIVE MOIETY | H231GF11BV | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| POLYSORBATE 80 | ACTIVE MOIETY | 6OZP39ZG8H | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| ALCOHOL | INACTIVE INGREDIENT | 3K9958V90M | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| BENZALKONIUM CHLORIDE | INACTIVE INGREDIENT | F5UM2KM3W7 | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| BORIC ACID | INACTIVE INGREDIENT | R57ZHV85D4 | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| CHLOROBUTANOL | INACTIVE INGREDIENT | HM4YQM8WRC | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| EDETATE DISODIUM | INACTIVE INGREDIENT | 7FLD91C86K | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| MENTHOL | INACTIVE INGREDIENT | L7T10EIP3A | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| SODIUM BORATE | INACTIVE INGREDIENT | 91MBZ8H3QO | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 6 | |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10742-8142 | ROHTO COOL (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 15 | Current NDC, Legacy NDC, 2 package rows | 20241219_69166dec-fb86-4c76-9efe-88c3bb12a8f0.zip |
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 |
|---|
| 10742-8142-1 | 10742814201 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8142-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR | 2001-08-21 | 0000-00-00 | No | No | Current |