Diclofenac Epolamine

Product NDC: 82347-0405
11-digit product format: 823470405
Labeler code: 82347
Product ID: 82347-0405_41a96431-3fd8-a73e-e063-6294a90a5ec5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Diclofenac Epolamine
Dosage form: SYSTEM
Route: TOPICAL
Labeler: YARAL Pharma Inc.
Application: NDA021234
Marketing category: NDA AUTHORIZED GENERIC
Marketing start: 2022-11-18
Substance: DICLOFENAC EPOLAMINE
Active strength: .013 g/1
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: 2026-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

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
N021234-001	FLECTOR	DICLOFENAC EPOLAMINE	1.3%	SYSTEM / TOPICAL		RLD, RS	2007-01-31

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	RLD / RS	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021234-001	FLECTOR	1.3%	PATCH / TOPICAL	RLD, RS	2007-01-31	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N021234-001	FLECTOR	1.3%	SYSTEM / TOPICAL	RLD, RS	2007-01-31	`cb3db0bc1861…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Coverage / status	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N021234-001	5607690	2019-04-13	Drug product	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N021234-001	5607690	2019-04-13	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N021234-001	5607690	2019-04-13	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N021234-001	5607690	2019-04-13	Drug product	`ea99ee380514…`

Additional Listing Data#

Finished product: Yes
Brand name base: Diclofenac Epolamine
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
DICLOFENAC EPOLAMINE	.013 g/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
X5F8EKL9ZG	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
855626	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
2d9bfacc-1b0c-4fab-b949-cd0c914089f9	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316
6084a4f4-5437-c9a5-caec-5361ee075a59	Product name	1	20140508
90c5639a-61b0-88d6-ddcf-21888e94869a	Product name	1	20140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
82347-0405-4	Diclofenac Epolamine	5 in 1 POUCH	SYSTEM	5	8
82347-0405-5	Diclofenac Epolamine	6 in 1 CARTON	SYSTEM	6	8
82347-0405-6	Diclofenac Epolamine	3 in 1 CARTON	SYSTEM	3	8

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
82347-0405-4	EA - Each	82347-0405	2dff4cf4-c3fe-4cc8-8985-304357ad4ad7	1	2023-01-09
82347-0405-5	EA - Each	82347-0405	edd00c0b-439d-4855-8a62-4edc83f3d34f	1	2023-01-09
82347-0405-6	EA - Each	82347-0405	00726a8d-0aa4-4a83-be2c-016a07018ed1	1	2026-04-20

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
82347-0405	DICLOFENAC EPOLAMINE SYSTEM [YARAL PHARMA INC.]	7	Current NDC, Legacy NDC, 3 package rows	20241201_2d9bfacc-1b0c-4fab-b949-cd0c914089f9.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 · 12 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	HAWAII REPACK, INC.	861907f7-a338-41c4-899e-48bd9a7e4749	2026-07-03	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Preferred Pharmaceuticals Inc.	1a5c4d2d-a819-4749-b4d4-7f2c099175a4	2026-06-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclox Patch 30CT	DICLOFENAC EPOLAMINE 1.3% PATCH	Injecta Medcial LLC	526cfe9e-0e22-60c5-e063-6294a90a697f	2026-05-22	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	Teva Pharmaceuticals USA Inc.	d7bfe17d-e88e-4792-bfba-cea56ed96c3b	2026-01-05	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
FLECTOR	DICLOFENAC EPOLAMINE	IBSA Pharma Inc.	1f19a016-c4fc-43c5-9990-e5f2e2776a82	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	YARAL Pharma Inc.	2d9bfacc-1b0c-4fab-b949-cd0c914089f9	2025-10-21	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234 ndc (product): 82347-0405
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Phoenix RX LLC	3fa49554-d85f-a1d5-e063-6294a90a8baf	2025-09-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	ASCLEMED USA INC.	f4471245-83d0-49f5-9cd5-3f7e76c799c4	2025-06-25	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	Advanced Rx of Tennessee, LLC	08b8737f-b6d2-77da-e063-6294a90a1a3e	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
diclofenac epolamine	DICLOFENAC EPOLAMINE	Quality Care Products, LLC	73182d59-97ad-44d4-ad9e-680dc575ab86	2024-12-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Advanced Rx Pharmacy of Tennessee, LLC	1b563e42-3b06-5320-e063-6294a90a30e5	2024-06-19	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234
Diclofenac Epolamine	DICLOFENAC EPOLAMINE	Asclemed USA, Inc.	45e191b6-c6c9-45f9-96d5-cf30f8aa910c	2024-02-26	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (NDA): 021234 application number: NDA021234

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
X5F8EKL9ZG	DICLOFENAC EPOLAMINE	119623-66-4	DICLOFENAC EPOLAMINE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	PSN	2d9bfacc-1b0c-4fab-b949-cd0c914089f9	8
855626	Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch	SCD	2d9bfacc-1b0c-4fab-b949-cd0c914089f9	8
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	SY	2d9bfacc-1b0c-4fab-b949-cd0c914089f9	8
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	PSN	1b563e42-3b06-5320-e063-6294a90a30e5	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	PSN	3fa49554-d85f-a1d5-e063-6294a90a8baf	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	PSN	45e191b6-c6c9-45f9-96d5-cf30f8aa910c	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	PSN	526cfe9e-0e22-60c5-e063-6294a90a697f	1
855626	Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch	SCD	1b563e42-3b06-5320-e063-6294a90a30e5	1
855626	Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch	SCD	3fa49554-d85f-a1d5-e063-6294a90a8baf	1
855626	Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch	SCD	45e191b6-c6c9-45f9-96d5-cf30f8aa910c	1
855626	Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch	SCD	526cfe9e-0e22-60c5-e063-6294a90a697f	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	SY	1b563e42-3b06-5320-e063-6294a90a30e5	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	SY	3fa49554-d85f-a1d5-e063-6294a90a8baf	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	SY	45e191b6-c6c9-45f9-96d5-cf30f8aa910c	1
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	SY	526cfe9e-0e22-60c5-e063-6294a90a697f	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
82347-0405-4	82347040504	5 in 1 POUCH						Historical
82347-0405-5	82347040505	6 POUCH in 1 CARTON (82347-0405-5) / 5 SYSTEM in 1 POUCH (82347-0405-4)	6 pouch	2022-11-18	0000-00-00	No	No	Current
82347-0405-6	82347040506	3 POUCH in 1 CARTON (82347-0405-6) / 5 SYSTEM in 1 POUCH (82347-0405-4)	3 pouch	2025-01-15		No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Diclofenac Epolamine - HAWAII REPACK, INC.	HAWAII REPACK, INC.	2026-07-03	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Epolamine - Preferred Pharmaceuticals Inc.	Preferred Pharmaceuticals Inc.	2026-06-08	HUMAN PRESCRIPTION DRUG LABEL	1
Diclox Patch 30CT	Injecta Medcial LLC	2026-05-22	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Epolamine - YARAL Pharma Inc.	YARAL Pharma Inc.	2025-10-21	HUMAN PRESCRIPTION DRUG LABEL	8
Diclofenac Epolamine - Phoenix RX LLC	Phoenix RX LLC	2025-09-25	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Epolamine - Advanced Rx Pharmacy of Tennessee, LLC	Advanced Rx Pharmacy of Tennessee, LLC	2024-06-19	HUMAN PRESCRIPTION DRUG LABEL	1
Diclofenac Epolamine - Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	Asclemed USA, Inc. \| ASCLEMED USA INC. DBA ENOVACHEM	2024-02-26	HUMAN PRESCRIPTION DRUG LABEL	1