Home NDC 11980-228 FML FORTE
Product NDC 11980-228
11-digit product format 119800228
Labeler code 11980
Product ID 11980-228_45789d76-a9c1-4ac5-84a1-fa2f9db729d9
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name fluorometholone
Dosage form SUSPENSION/ DROPS
Route OPHTHALMIC
Labeler Allergan, Inc.
Application NDA019216
Marketing category NDA
Marketing start 1986-05-01
Substance FLUOROMETHOLONE
Active strength 2.5 mg/mL
Pharmacologic classes Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 42 .
Orange Book products# Current product rows page 1 of 1 · 1 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019216-001 FML FORTE FLUOROMETHOLONE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23
Observed Orange Book product history# Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.
Product history page 1 of 2 · 42 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-08-18 06:07:40 2026-07 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 87673890dc5c…2021-03-12 10:30 UTC 2021-03 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 3f01610625f2…2019-09-15 20:21 UTC 2019-09 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 b00525d2431f…2019-07-19 19:46 UTC 2019-07 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 053a50430f4f…2023-01-26 05:58 UTC 2023-01 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 f41ea6bd6efb…2022-09-29 23:25 UTC 2022-09 N019216-001 FML FORTE 0.25% SUSPENSION/DROPS / OPHTHALMIC RLD, RS 1986-04-23 e64feba35796…
Additional Listing Data#
Finished product Yes
Brand name base FML FORTE
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength FLUOROMETHOLONE 2.5 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SV0CSG527L Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 208420 Internal RxNorm lookup 310376 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11980-228-05 FML FORTE 5 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 5 16 11980-228-05 FML FORTE 1 in 1 CARTON SUSPENSION/ DROPS 1 16 11980-228-10 FML FORTE 1 in 1 CARTON SUSPENSION/ DROPS 1 16 11980-228-10 FML FORTE 10 mL in 1 BOTTLE, DROPPER SUSPENSION/ DROPS 10 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded fluorometholone ACTIVE INGREDIENT SV0CSG527L FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 fluorometholone ACTIVE MOIETY SV0CSG527L FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 benzalkonium chloride INACTIVE INGREDIENT F5UM2KM3W7 FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 edetate disodium INACTIVE INGREDIENT 7FLD91C86K FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 polysorbate 80 INACTIVE INGREDIENT 6OZP39ZG8H FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 polyvinyl alcohol INACTIVE INGREDIENT 532B59J990 FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 sodium chloride INACTIVE INGREDIENT 451W47IQ8X FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 sodium hydroxide INACTIVE INGREDIENT 55X04QC32I FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 sodium phosphate, dibasic INACTIVE INGREDIENT GR686LBA74 FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 sodium phosphate, monobasic INACTIVE INGREDIENT 3980JIH2SW FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4 water INACTIVE INGREDIENT 059QF0KO0R FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11980-228 FML FORTE (FLUOROMETHOLONE) SUSPENSION/ DROPS [ALLERGAN, INC.] 16 Current NDC, Legacy NDC, 4 package rows 20250223_b810b4c3-ac7a-4ba5-85bf-ebfaf3b1dabf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 1 of 1 · 1 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 11980-228-05 11980022805 1 BOTTLE, DROPPER in 1 CARTON (11980-228-05) / 5 mL in 1 BOTTLE, DROPPER 1986-05-01 0000-00-00 No No Current 11980-228-10 11980022810 1 BOTTLE, DROPPER in 1 CARTON (11980-228-10) / 10 mL in 1 BOTTLE, DROPPER 1986-05-01 0000-00-00 No No Current