Home NDC 24208-457 Diclofenac Sodium
Product NDC 24208-457
11-digit product format 242080457
Labeler code 24208
Product ID 24208-457_4965dd94-e9f5-0494-e063-6294a90ac40f
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name Diclofenac Sodium
Dosage form SOLUTION/ DROPS
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application ANDA078792
Marketing category ANDA
Marketing start 2007-12-28
Substance DICLOFENAC SODIUM
Active strength 1 mg/mL
Pharmacologic classes Anti-Inflammatory Agents, Non-Steroidal [CS], Cyclooxygenase Inhibitors [MoA], Decreased Prostaglandin Production [PE], Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 43 .
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 A078792-001 DICLOFENAC SODIUM DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 1 matching rows.
Application-product, TE code table Application-product TE code A078792-001 AT
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 · 43 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 2026-09-14 22:38:34 2026-08 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 84e616aacf4f…2026-08-18 06:07:40 2026-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 caaa826d4ba7…2026-02-19 14:30 UTC 2026-02 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 782e0a99824c…2021-05-05 16:15 UTC · 3 captures of this ZIP 2021-05 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 87673890dc5c…2021-03-12 10:30 UTC 2021-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 5aa47cf7b7d7…2020-12-22 03:56 UTC 2020-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 8869cabd3fbd…2020-11-12 02:37 UTC 2020-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 c0c555d07b60…2019-12-14 00:12 UTC 2019-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 3f01610625f2…2019-09-15 20:21 UTC 2019-09 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 b00525d2431f…2019-07-19 19:46 UTC 2019-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT 2007-12-28 ea99ee380514…2024-03-16 18:09 UTC · 4 captures of this ZIP 2024-03 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 6a51e52b5d6a…2024-02-18 07:12 UTC 2024-02 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 1c564ffb4f44…2023-12-20 04:57 UTC 2023-12 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 ea1830bbd6c7…2023-11-28 05:40 UTC · 2 captures of this ZIP 2023-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 a72a2bbeb626…2023-10-25 00:34 UTC · 2 captures of this ZIP 2023-10 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 9b2671bbb829…2023-07-15 15:27 UTC · 2 captures of this ZIP 2023-07 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 a67488948f0b…2023-06-13 01:57 UTC · 3 captures of this ZIP 2023-06 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 3f0d92c62455…2023-05-13 08:27 UTC 2023-05 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 053a50430f4f…2023-01-26 05:58 UTC 2023-01 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 3bdfa0b2c4d7…2022-11-12 20:34 UTC · 5 captures of this ZIP 2022-11 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 3a93d1ddd44b…2022-10-28 04:53 UTC 2022-10 A078792-001 DICLOFENAC SODIUM 0.1% SOLUTION/DROPS / OPHTHALMIC AT RS 2007-12-28 f41ea6bd6efb…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 2 · 43 observed states.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Diclofenac Sodium
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DICLOFENAC SODIUM 1 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination QTG126297Q Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 854801 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 24208-457-05 Diclofenac Sodium 1 in 1 CARTON SOLUTION/ DROPS 1 14 24208-457-05 Diclofenac Sodium 5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 5 14 24208-457-25 Diclofenac Sodium 2.5 mL in 1 BOTTLE, DROPPER SOLUTION/ DROPS 2.5 14 24208-457-25 Diclofenac Sodium 1 in 1 CARTON SOLUTION/ DROPS 1 14
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 SORBIC ACID INACTIVE INGREDIENT X045WJ989B DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 WATER INACTIVE INGREDIENT 059QF0KO0R DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 5 DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 SORBIC ACID INACTIVE INGREDIENT X045WJ989B DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 WATER INACTIVE INGREDIENT 059QF0KO0R DICLOFENAC SODIUM SOLUTION/ DROPS [PHYSICIANS TOTAL CARE, INC.] 2 DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 DICLOFENAC SODIUM ACTIVE INGREDIENT QTG126297Q DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 DICLOFENAC ACTIVE MOIETY 144O8QL0L1 DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 BORIC ACID INACTIVE INGREDIENT R57ZHV85D4 DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 EDETATE DISODIUM INACTIVE INGREDIENT 7FLD91C86K DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 POLYOXYL 35 CASTOR OIL INACTIVE INGREDIENT 6D4M1DAL6O DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 SORBIC ACID INACTIVE INGREDIENT X045WJ989B DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DICLOFENAC SODIUM SOLUTION/ DROPS [H.J. HARKINS COMPANY, INC.] 1 WATER INACTIVE INGREDIENT 059QF0KO0R DICLOFENAC SODIUM SOLUTION/ DROPS [REBEL DISTRIBUTORS CORP] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-457 DICLOFENAC SODIUM SOLUTION/ DROPS [BAUSCH & LOMB INCORPORATED] 12 Current NDC, Legacy NDC, 4 package rows 20240726_39dfffb0-612a-48f3-8db5-1a59899b91e9.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 · 2 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 24208-457-05 24208045705 1 BOTTLE, DROPPER in 1 CARTON (24208-457-05) / 5 mL in 1 BOTTLE, DROPPER 2007-12-28 0000-00-00 No No Current 24208-457-25 24208045725 1 BOTTLE, DROPPER in 1 CARTON (24208-457-25) / 2.5 mL in 1 BOTTLE, DROPPER 2007-12-28 0000-00-00 No No Current