Rohto
- Product NDC
- 10742-8158
- 11-digit product format
- 107428158
- Labeler code
- 10742
- Product ID
- 10742-8158_2978d1db-836a-05d4-e063-6294a90a6943
- 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
- 2021-05-12
- Substance
- NAPHAZOLINE HYDROCHLORIDE; POLYSORBATE 80
- Active strength
- .3; 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
- Max Strength
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| NAPHAZOLINE HYDROCHLORIDE | .3 mg/mL |
| POLYSORBATE 80 | 2 mg/mL |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | MZ1131787D, 6OZP39ZG8H |
| Rxcui | 1535485 |
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 |
|---|
| 10742-8158-1 | RohtoMax Strength | 1 in 1 CARTON | LIQUID | 1 | | 4 |
| 10742-8158-1 | RohtoMax Strength | 13 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 13 | | 4 |
| 10742-8158-2 | RohtoMax Strength | 13 mL in 1 BOTTLE, WITH APPLICATOR | LIQUID | 13 | | 4 |
| 10742-8158-2 | RohtoMax Strength | 2 in 1 CARTON | LIQUID | 2 | | 4 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 10742-8158 | ROHTO MAX STRENGTH (NAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80) LIQUID [THE MENTHOLATUM COMPANY] | 4 | Current NDC, Legacy NDC, 4 package rows | 20241219_e4b49550-1ca3-4bd7-854d-409b53fa5e26.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 |
|---|
| 10742-8158-1 | 10742815801 | 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR | 2021-05-12 | 0000-00-00 | No | No | Current |
| 10742-8158-2 | 10742815802 | 2 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-2) / 13 mL in 1 BOTTLE, WITH APPLICATOR | 2021-05-12 | 0000-00-00 | No | No | Current |