FDA.reportPublic FDA data

Rugby Artificial Tears

Product NDC
0536-1086
Requested package NDC
0536-1086-91
11-digit product format
005361086
Labeler code
0536
Product ID
0536-1086_7cf217ce-89d0-1dac-e053-2991aa0ae9bb
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral oil and White petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Rugby Laboratories, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2015-09-10
Marketing end
0000-00-00
Substance
MINERAL OIL; PETROLATUM
Active strength
150 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2020-12-31
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
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0536-10860536-1086-91DDiscontinued by firm2026-10-05

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 · 12 matching rows.

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

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0536-1086-91GM - Gram0536-10865217c8c4-edc1-41d5-8298-45ec6b86e7b512016-02-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MINERAL OILACTIVE INGREDIENTT5L8T28FGPRUGBY ARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [RUGBY LABORATORIES, INC.]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9URUGBY ARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [RUGBY LABORATORIES, INC.]1
MINERAL OILACTIVE MOIETYT5L8T28FGPRUGBY ARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [RUGBY LABORATORIES, INC.]1
PETROLATUMACTIVE MOIETY4T6H12BN9URUGBY ARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [RUGBY LABORATORIES, INC.]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HERUGBY ARTIFICIAL TEARS (MINERAL OIL AND WHITE PETROLATUM) OINTMENT [RUGBY LABORATORIES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0536-1086-91005361086911 TUBE in 1 CARTON (0536-1086-91) > 3.5 g in 1 TUBE1 tube2016-11-080000-00-00NoNoCurrent