rohto max strength

Generic: naphazoline hydrochloride, polysorbate 80

Labeler: the mentholatum company
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name rohto max strength
Generic Name naphazoline hydrochloride, polysorbate 80
Labeler the mentholatum company
Dosage Form LIQUID
Routes
OPHTHALMIC
Active Ingredients

naphazoline hydrochloride .3 mg/mL, polysorbate 80 2 mg/mL

Manufacturer
The Mentholatum Company

Identifiers & Regulatory

Product NDC 10742-8158
Product ID 10742-8158_2978d1db-836a-05d4-e063-6294a90a6943
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2021-05-12

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 107428158
Hyphenated Format 10742-8158

Supplemental Identifiers

RxCUI
1535485
UNII
MZ1131787D 6OZP39ZG8H

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name rohto max strength (source: ndc)
Generic Name naphazoline hydrochloride, polysorbate 80 (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • .3 mg/mL
  • 2 mg/mL
source: ndc
Packaging
  • 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR
  • 2 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-2) / 13 mL in 1 BOTTLE, WITH APPLICATOR
source: ndc

Packages (2)

10742-8158-1 1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-1) / 13 mL in 1 BOTTLE, WITH APPLICATOR 10742-8158-2 2 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-2) / 13 mL in 1 BOTTLE, WITH APPLICATOR

Ingredients (2)

naphazoline hydrochloride (.3 mg/mL) polysorbate 80 (2 mg/mL)

Linked Drug Pages (1)

Rohto Max Strength ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "2978d1db-836a-05d4-e063-6294a90a6943", "openfda": {"unii": ["MZ1131787D", "6OZP39ZG8H"], "rxcui": ["1535485"], "spl_set_id": ["e4b49550-1ca3-4bd7-854d-409b53fa5e26"], "manufacturer_name": ["The Mentholatum Company"], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-1)  / 13 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "10742-8158-1", "marketing_start_date": "20210512"}, {"sample": false, "description": "2 BOTTLE, WITH APPLICATOR in 1 CARTON (10742-8158-2)  / 13 mL in 1 BOTTLE, WITH APPLICATOR", "package_ndc": "10742-8158-2", "marketing_start_date": "20210512"}], "brand_name": "Rohto Max Strength", "product_id": "10742-8158_2978d1db-836a-05d4-e063-6294a90a6943", "dosage_form": "LIQUID", "product_ndc": "10742-8158", "generic_name": "Naphazoline hydrochloride, Polysorbate 80", "labeler_name": "The Mentholatum Company", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Rohto", "brand_name_suffix": "Max Strength", "active_ingredients": [{"name": "NAPHAZOLINE HYDROCHLORIDE", "strength": ".3 mg/mL"}, {"name": "POLYSORBATE 80", "strength": "2 mg/mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20210512", "listing_expiration_date": "20261231"}