Rugby Lubricating Drops

Product NDC: 0536-1325
Requested package NDC: 0536-1325-94
11-digit product format: 005361325
Labeler code: 0536
Product ID: 0536-1325_c0549236-9a47-3306-e053-2995a90a2011
Type: HUMAN OTC DRUG
Nonproprietary name: Polyvinyl Alcohol
Dosage form: SOLUTION/ DROPS
Route: OPHTHALMIC
Labeler: Rugby
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2021-04-19
Marketing end: 0000-00-00
Substance: POLYVINYL ALCOHOL
Active strength: 14 mg/mL
NDC exclude flag: No
Listing certified through: 2022-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0536-1325	0536-1325-94	D	Discontinued by firm		2026-10-05

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 8 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Code, Status table
Captured / source date	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	D	Discontinued by firm	`f5e01cc5f278…`	`a2eaf40c39c3…`
2024-11-09 02:27 UTC · source 2024-11-08	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	I	Inactivated by FDA	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	I	Inactivated by FDA	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	I	Inactivated by FDA	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	I	Inactivated by FDA	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0536-1325-94	2024-11-20	C162847	48780-1	1030e365-54d8-111a-e063-dadaa90a10e2	Rugby Lubricating Eye Drops
0536-1325-94	2024-01-30	C162847	48780-1	1030e365-54d8-111a-e063-dadaa90a10e2	Rugby Lubricating Eye Drops

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1325-94	ML - Milliliter	0536-1325	156bc4a3-a756-4307-8d9a-c7ce60d977f9	1	2021-12-08

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	PSN	f2e26f85-4081-425b-9c81-ac2a079a5743	4
142004	polyvinyl alcohol 0.014 ML/ML Ophthalmic Solution	SCD	f2e26f85-4081-425b-9c81-ac2a079a5743	4
142004	polyvinyl alcohol 1.4 % Ophthalmic Solution	SY	f2e26f85-4081-425b-9c81-ac2a079a5743	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0536-1325-94	00536132594	15 mL in 1 BOTTLE (0536-1325-94)	15 ml	2021-04-19	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Rugby Lubricating Eye Drops	Rugby Laboratories	2024-11-20	HUMAN OTC DRUG LABEL	2
Rugby Lubricating Eye Drops	A-S Medication Solutions	2023-11-10	HUMAN OTC DRUG LABEL	4