FLECTOR

Product NDC: 61919-566
11-digit product format: 619190566
Labeler code: 61919
Product ID: 61919-566_4418b335-8108-1395-e054-00144ff88e88
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: FLECTOR
Dosage form: PATCH
Route: TOPICAL
Labeler: DIRECT RX
Application: NDA021234
Marketing category: NDA
Marketing start: 2014-01-01
Marketing end: 0000-00-00
Substance: DICLOFENAC EPOLAMINE
Active strength: 180 mg/1
Pharmacologic classes: Cyclooxygenase Inhibitors [MoA],Decreased Prostaglandin Production [PE],Anti-Inflammatory Agents, Non-Steroidal [CS],Nonsteroidal Anti-inflammatory Drug [EPC]
NDC exclude flag: E
Listing certified through: 2017-12-31
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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	61919-566		U	Excluded because listing certification expired		2026-08-03
excluded package	package	61919-566	61919-566-30	U	Excluded because listing certification expired		2026-08-03

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 · 44 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	61919-566-30	U	Excluded because listing certification expired	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	61919-566-30	E	Excluded after deficient or non-compliant submission was not corrected	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	61919-566-30	E	Excluded after deficient or non-compliant submission was not corrected	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	61919-566-30	E	Excluded after deficient or non-compliant submission was not corrected	`110d247fa046…`	`a55b01930146…`

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…`

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	Strength	SPL version
61919-566-30	FLECTOR	30 in 1 CARTON	PATCH	30		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
61919-566-30	EA - Each	61919-566	663e7788-d204-4c93-b637-21087459908e	1	2016-04-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Diclofenac Epolamine	ACTIVE INGREDIENT	X5F8EKL9ZG	FLECTOR PATCH [DIRECT RX]	1
DICLOFENAC	ACTIVE MOIETY	144O8QL0L1	FLECTOR PATCH [DIRECT RX]	1
Butylene Glycol	INACTIVE INGREDIENT	3XUS85K0RA	FLECTOR PATCH [DIRECT RX]	1
Dihydroxyaluminum Aminoacetate	INACTIVE INGREDIENT	DO250MG0W6	FLECTOR PATCH [DIRECT RX]	1
Edetate Disodium	INACTIVE INGREDIENT	7FLD91C86K	FLECTOR PATCH [DIRECT RX]	1
Gelatin	INACTIVE INGREDIENT	2G86QN327L	FLECTOR PATCH [DIRECT RX]	1
Kaolin	INACTIVE INGREDIENT	24H4NWX5CO	FLECTOR PATCH [DIRECT RX]	1
Methylparaben	INACTIVE INGREDIENT	A2I8C7HI9T	FLECTOR PATCH [DIRECT RX]	1
Polysorbate 80	INACTIVE INGREDIENT	6OZP39ZG8H	FLECTOR PATCH [DIRECT RX]	1
Povidones	INACTIVE INGREDIENT	FZ989GH94E	FLECTOR PATCH [DIRECT RX]	1
Propylene Glycol	INACTIVE INGREDIENT	6DC9Q167V3	FLECTOR PATCH [DIRECT RX]	1
Propylparaben	INACTIVE INGREDIENT	Z8IX2SC1OH	FLECTOR PATCH [DIRECT RX]	1
Sorbitol	INACTIVE INGREDIENT	506T60A25R	FLECTOR PATCH [DIRECT RX]	1
Tartaric Acid	INACTIVE INGREDIENT	W4888I119H	FLECTOR PATCH [DIRECT RX]	1
Titanium Dioxide	INACTIVE INGREDIENT	15FIX9V2JP	FLECTOR PATCH [DIRECT RX]	1
Water	INACTIVE INGREDIENT	059QF0KO0R	FLECTOR PATCH [DIRECT RX]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
61919-566	FLECTOR PATCH [DIRECT RX]	4	Legacy NDC, 1 package rows	20161220_0f11e37c-1aa4-455a-98b8-6aae72294a25.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
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	0f11e37c-1aa4-455a-98b8-6aae72294a25	4
855626	Twice-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch	SCD	0f11e37c-1aa4-455a-98b8-6aae72294a25	4
855626	diclofenac epolamine 1.3 % Twice-Daily Medicated Patch	SY	0f11e37c-1aa4-455a-98b8-6aae72294a25	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Status
61919-566-30	61919056630	30 in 1 CARTON	Historical