FDA.reportPublic FDA data

Isopto Tears

Product NDC
0998-0408
Requested package NDC
0998-0408-15
11-digit product format
009980408
Labeler code
0998
Product ID
0998-0408_3a17eeaa-75f7-48c1-94be-baf49067b9d5
Type
HUMAN OTC DRUG
Nonproprietary name
Hypromellose 2910
Dosage form
SOLUTION
Route
OPHTHALMIC
Labeler
Alcon Laboratories, Inc.
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
1990-09-30
Marketing end
0000-00-00
Substance
HYPROMELLOSE 2910 (4000 MPA.S)
Active strength
5 mg/mL
NDC exclude flag
No
Listing certified through
2023-12-31
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 packagepackage0998-04080998-0408-15DDiscontinued by firm2026-08-11

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 · 9 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…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0998-0408-15ML - Milliliter0998-0408d8e71ea3-1a7d-482a-aecb-a4afdc60e69812014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Hypromellose 2910 (4000 Mpa.s)ACTIVE INGREDIENTRN3152OP35ISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
Hypromellose 2910 (4000 Mpa.s)ACTIVE MOIETYRN3152OP35ISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7ISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8XISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
Sodium Phosphate, DibasicINACTIVE INGREDIENTGR686LBA74ISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
Sodium Phosphate, MonobasicINACTIVE INGREDIENT3980JIH2SWISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1
WaterINACTIVE INGREDIENT059QF0KO0RISOPTO TEARS (HYPROMELLOSE 2910) SOLUTION [ALCON LABORATORIES, INC.]1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0998-0408-150099804081515 mL in 1 BOTTLE, DROPPER (0998-0408-15) 15 ml1990-09-300000-00-00NoNoCurrent