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NDC 00536-1254-94 Sodium Chlorode Hypertonicity Ophthalmic Solution 50 mg/mL Details

Sodium Chlorode Hypertonicity Ophthalmic Solution 50 mg/mL

Sodium Chlorode Hypertonicity Ophthalmic Solution is a OPHTHALMIC SOLUTION in the HUMAN OTC DRUG category. It is labeled and distributed by Rugby Laboratories. The primary component is SODIUM CHLORIDE.

Product Information

NDC	00536-1254
Product ID	0536-1254_822d25c0-71b3-421d-b702-4cded0c4ca32
Associated GPIs	86804030102005
GCN Sequence Number	007739
GCN Sequence Number Description	sodium chloride DROPS 5 % OPHTHALMIC
HIC3	Q6A
HIC3 Description	OPHTHALMIC PREPARATIONS, MISCELLANEOUS
GCN	31923
HICL Sequence Number	003389
HICL Sequence Number Description	SODIUM CHLORIDE
Brand/Generic	Generic
Proprietary Name	Sodium Chlorode Hypertonicity Ophthalmic Solution
Proprietary Name Suffix	n/a
Non-Proprietary Name	sodium chloride
Product Type	HUMAN OTC DRUG
Dosage Form	SOLUTION
Route	OPHTHALMIC
Active Ingredient Strength	50
Active Ingredient Units	mg/mL
Substance Name	SODIUM CHLORIDE
Labeler Name	Rugby Laboratories
Pharmaceutical Class	Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC]
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part349
Listing Certified Through	2024-12-31

Package

Package Images

NDC 00536-1254-94 (00536125494)

Pricing Information
NDC Package Code	0536-1254-94
Billing NDC	00536125494
Package	1 BOTTLE in 1 CARTON (0536-1254-94) / 15 mL in 1 BOTTLE
Marketing Start Date	2020-09-17
NDC Exclude Flag	N
Price Per Unit	0.26936
Pricing Unit	ML
Effective Date	2024-02-21
NDC Description	SODIUM CHLORIDE 5% EYE DROP
Pharmacy Type Indicator	C/I
OTC	Y
Explanation Code	1, 5
Classification for Rate Setting	G
As of Date	2024-02-21

This pricing file, entitled the NADAC (National Average Drug Acquisition Cost) files, provide state Medicaid agencies with covered outpatient drug prices by averaging survey invoice prices from retail community pharmacies across the United States. These pharmacies include independent retail community pharmacies and chain pharmacies. The prices are updated on a weekly and monthly basis

Standard Product Labeling (SPL)/Prescribing Information SPL 822d25c0-71b3-421d-b702-4cded0c4ca32 Details

Drug Facts

Active ingredients

Sodium chloride 5%

Purpose

Hypertonicity agent

Uses

temporary relief of corneal edema

Warnings

Do not use

•: except under the advice and supervision of a doctor
•: if solution changes color or becomes cloudy

When using this product

•: it may cause temporary burning and irritation
•: to avoid contamination do not touch tip of container to any surface
•: replace cap after use

Stop use and ask a doctor if

•: condition worsens or persists for more than 72 hours
•: you experience eye pain, changes in vision, continued redness or irritation of the eye

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

: instill 1 or 2 drops in the affected eye(s) every 3 or 4 hours, or as directed by a physician.

Other information

•: store upright at 15° - 25°C (59° - 77°F)
•: keep tightly closed
•: serious side effects associated with use of the product may be reported to the phone number provided below

Inactive ingredients

boric acid, hypromellose, propylene glycol, purified water, sodium borate. Hydrochloric acid and/or sodium hydroxide may be added to adjust pH. PRESERVATIVES ADDED: methylparaben 0.023%, propylparaben 0.01%.

Questions?

[phone icon] Call 1-800-645-2158

Package/Label Principal Display Panel – carton

NDC 0536-1254-94

Rugby®

Sodium Chloride

Hypertonicity

Ophthalmic

Solution, 5%

STERILE

1/2 FL. OZ. (15 mL)

INGREDIENTS AND APPEARANCE

SODIUM CHLORODE HYPERTONICITY OPHTHALMIC SOLUTION

sodium chloride solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:0536-1254
Route of Administration	OPHTHALMIC

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)	SODIUM CHLORIDE	50 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
BORIC ACID (UNII: R57ZHV85D4)
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)
HYDROCHLORIC ACID (UNII: QTT17582CB)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:0536-1254-94	1 in 1 CARTON	09/17/2020
1		15 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/17/2020

Labeler - Rugby Laboratories (079246066)

Name	Address	ID/FEI	Business Operations
Establishment
Bausch & Lomb Incorporated		079587625	MANUFACTURE(0536-1254)

Revised: 9/2020

Document Id: 822d25c0-71b3-421d-b702-4cded0c4ca32

Set id: 822d25c0-71b3-421d-b702-4cded0c4ca32

Version: 1

Effective Time: 20200917