optic splash

Generic: naphazoline hydrochloride, glycerin

Labeler: sato pharmaceutical, co., ltd.
NDC Directory HUMAN OTC DRUG OTC MONOGRAPH DRUG Inactive Finished

Drug Facts

Product Profile

Brand Name optic splash
Generic Name naphazoline hydrochloride, glycerin
Labeler sato pharmaceutical, co., ltd.
Dosage Form SOLUTION/ DROPS
Routes
OPHTHALMIC
Active Ingredients

glycerin 200 mg/100mL, naphazoline hydrochloride 20 mg/100mL

Manufacturer
Sato Pharmaceutical, Co., Ltd.

Identifiers & Regulatory

Product NDC 49873-501
Product ID 49873-501_0bb98362-089f-f332-e063-6394a90ad51f
Product Type HUMAN OTC DRUG
Marketing Category OTC MONOGRAPH DRUG
Application Number M018
Listing Expiration 2026-12-31
Marketing Start 2008-01-22

Pharmacologic Class

Established (EPC)
non-standardized chemical allergen [epc]
Chemical Structure
allergens [cs] glycerol [cs]
Physiologic Effect
increased histamine release [pe] cell-mediated immunity [pe] increased igg production [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 49873501
Hyphenated Format 49873-501

Supplemental Identifiers

RxCUI
1243999
UPC
0349873502014
UNII
PDC6A3C0OX MZ1131787D
NUI
N0000185370 N0000175629 N0000184306 N0000185001 M0000728 M0009417

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 optic splash (source: ndc)
Generic Name naphazoline hydrochloride, glycerin (source: ndc)
Application Number M018 (source: ndc)
Routes
OPHTHALMIC
source: ndc

Resolved Composition

Strengths
  • 200 mg/100mL
  • 20 mg/100mL
source: ndc
Packaging
  • 1 BOTTLE in 1 CARTON (49873-501-01) / 15 mL in 1 BOTTLE
source: ndc

Packages (1)

49873-501-01 1 BOTTLE in 1 CARTON (49873-501-01) / 15 mL in 1 BOTTLE

Ingredients (2)

glycerin (200 mg/100mL) naphazoline hydrochloride (20 mg/100mL)

Linked Drug Pages (1)

Optic Splash ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["OPHTHALMIC"], "spl_id": "0bb98362-089f-f332-e063-6394a90ad51f", "openfda": {"nui": ["N0000185370", "N0000175629", "N0000184306", "N0000185001", "M0000728", "M0009417"], "upc": ["0349873502014"], "unii": ["PDC6A3C0OX", "MZ1131787D"], "rxcui": ["1243999"], "spl_set_id": ["e3d60c20-7cbc-4728-8e42-441b64608b88"], "pharm_class_cs": ["Allergens [CS]", "Glycerol [CS]"], "pharm_class_pe": ["Increased Histamine Release [PE]", "Cell-mediated Immunity [PE]", "Increased IgG Production [PE]"], "pharm_class_epc": ["Non-Standardized Chemical Allergen [EPC]"], "manufacturer_name": ["Sato Pharmaceutical, Co., Ltd."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "1 BOTTLE in 1 CARTON (49873-501-01)  / 15 mL in 1 BOTTLE", "package_ndc": "49873-501-01", "marketing_start_date": "20080122"}], "brand_name": "Optic Splash", "product_id": "49873-501_0bb98362-089f-f332-e063-6394a90ad51f", "dosage_form": "SOLUTION/ DROPS", "pharm_class": ["Allergens [CS]", "Cell-mediated Immunity [PE]", "Glycerol [CS]", "Increased Histamine Release [PE]", "Increased IgG Production [PE]", "Non-Standardized Chemical Allergen [EPC]"], "product_ndc": "49873-501", "generic_name": "naphazoline hydrochloride, glycerin", "labeler_name": "Sato Pharmaceutical, Co., Ltd.", "product_type": "HUMAN OTC DRUG", "brand_name_base": "Optic Splash", "active_ingredients": [{"name": "GLYCERIN", "strength": "200 mg/100mL"}, {"name": "NAPHAZOLINE HYDROCHLORIDE", "strength": "20 mg/100mL"}], "application_number": "M018", "marketing_category": "OTC MONOGRAPH DRUG", "marketing_start_date": "20080122", "listing_expiration_date": "20261231"}