FDA.reportPublic FDA data

GenTeal

Product NDC
0078-0429
11-digit product format
000780429
Labeler code
0078
Product ID
0078-0429_2f179d51-adb1-43f8-b17e-bebff4c0fe84
Type
HUMAN OTC DRUG
Nonproprietary name
HYPROMELLOSE
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Novartis Pharmaceuticals Corporation
Application
part349
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2009-09-14
Marketing end
2021-08-31
Substance
HYPROMELLOSE 2910 (4000 MPA.S)
Active strength
0 g/g
NDC exclude flag
No
Listing certified through
0000-00-00
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 · 4 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded productproduct0078-0429DDiscontinued by firm2026-08-10
excluded packagepackage0078-04290078-0429-47DDiscontinued by firm2026-08-10
excluded packagepackage0078-04290078-0429-57DDiscontinued by firm2026-08-10
excluded packagepackage0078-04290078-0429-97DDiscontinued by firm2026-08-10

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 · 48 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05excluded productproductd630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0078-0429-57d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0078-0429-47d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-05excluded packagepackage0078-0429-97d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26excluded productproductf5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0078-0429-57f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0078-0429-47f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-26excluded packagepackage0078-0429-97f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-31excluded productproduct2ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0078-0429-572ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0078-0429-472ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-31excluded packagepackage0078-0429-972ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28excluded productproducta1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0078-0429-57a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0078-0429-47a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-28excluded packagepackage0078-0429-97a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21excluded productproductcfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0078-0429-57cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0078-0429-47cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-21excluded packagepackage0078-0429-97cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10excluded productproductcdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0078-0429-57cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0078-0429-47cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-10excluded packagepackage0078-0429-97cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0078-0429-57302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0078-0429-47302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage0078-0429-97302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0078-0429-57ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0078-0429-47ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage0078-0429-97ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0078-0429-570efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0078-0429-470efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage0078-0429-970efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08excluded productproductad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0078-0429-57ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0078-0429-47ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-08excluded packagepackage0078-0429-97ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03excluded productproduct367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0078-0429-57367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0078-0429-47367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-03excluded packagepackage0078-0429-97367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09excluded productproduct557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0078-0429-57557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0078-0429-47557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-09excluded packagepackage0078-0429-97557ba5c1ecfa…9c80585c8c6e…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0078-0429-47GM - Gram0078-04293b0a313f-7f6a-4ea1-ae11-168a20fb370912012-07-24
0078-0429-57GM - Gram0078-0429e803f12c-547c-406f-8364-a7d9a4bca15412016-07-19
0078-0429-97GM - Gram0078-04298ba22af6-8ee3-476b-949e-d1718c13fb5d12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
HYPROMELLOSE 2910 (4000 MPA.S)ACTIVE INGREDIENTRN3152OP35GENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3
HYPROMELLOSE 2910 (4000 MPA.S)ACTIVE MOIETYRN3152OP35GENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3
PHOSPHORIC ACIDINACTIVE INGREDIENTE4GA8884NNGENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3
SODIUM HYDROXIDEINACTIVE INGREDIENT55X04QC32IGENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3
SODIUM PERBORATEINACTIVE INGREDIENTY52BK1W96CGENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3
SORBITOLINACTIVE INGREDIENT506T60A25RGENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3
WATERINACTIVE INGREDIENT059QF0KO0RGENTEAL SEVERE (HYPROMELLOSE) GEL [NOVARTIS PHARMACEUTICALS CORPORATION]3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0078-0429-47000780429471 TUBE in 1 CARTON (0078-0429-47) > 10 g in 1 TUBE1 tube2009-09-142021-08-31NoNoCurrent