LICART

Product NDC
71858-0305
11-digit product format
718580305
Labeler code
71858
Product ID
71858-0305_4e7d176c-1593-6214-e063-6394a90a4042
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
diclofenac epolamine
Dosage form
SYSTEM
Route
TOPICAL
Labeler
IBSA Pharma Inc.
Application
NDA206976
Marketing category
NDA
Marketing start
2020-09-01
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
2027-12-31
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206976-001LICARTDICLOFENAC EPOLAMINE1.3%SYSTEM / TOPICALRLD, RS2018-12-19

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206976-001113445202035-02-20U-33932022-06-29
N206976-001113511332035-02-20U-33932022-06-29

Orange Book exclusivity#

Current exclusivity rows page 1 of 1 · 1 matching rows.

Application-product, Exclusivity code, Expiration table
Application-productExclusivity codeExpiration
N206976-001NPP2029-03-27

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
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-1931067a03dcf5…
2025-08-23 18:47 UTC2025-08N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-196a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-1903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-192680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-195bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-1979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-191e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-198072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-195c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-195d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-194b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206976-001LICART1.3%SYSTEM / TOPICALRLD2018-12-1974a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206976-001LICART1.3%SYSTEM / TOPICALRLD2018-12-193f01610625f2…
2019-09-15 20:21 UTC2019-09N206976-001LICART1.3%SYSTEM / TOPICALRLD2018-12-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N206976-001LICART1.3%SYSTEM / TOPICALRLD2018-12-19ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-196a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-191c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-199b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-193f0d92c62455…
2023-05-13 08:27 UTC2023-05N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19053a50430f4f…
2023-01-26 05:58 UTC2023-01N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-193bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-193a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N206976-001LICART1.3%SYSTEM / TOPICALRLD, RS2018-12-19cb3db0bc1861…

Observed Orange Book patent history#

Patent history page 1 of 2 · 56 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-02-19 14:30 UTC2026-02N206976-001113445202035-02-20U-33932022-06-29011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206976-001113511332035-02-20U-33932022-06-29011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206976-001113445202035-02-20U-33932022-06-2931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206976-001113511332035-02-20U-33932022-06-2931067a03dcf5…
2025-08-23 18:47 UTC2025-08N206976-001113445202035-02-20U-33932022-06-296a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206976-001113511332035-02-20U-33932022-06-296a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206976-001113445202035-02-20U-33932022-06-29fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206976-001113511332035-02-20U-33932022-06-29fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206976-001113445202035-02-20U-33932022-06-29b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206976-001113511332035-02-20U-33932022-06-29b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206976-001113445202035-02-20U-33932022-06-2903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206976-001113511332035-02-20U-33932022-06-2903ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206976-001113445202035-02-20U-33932022-06-292680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206976-001113511332035-02-20U-33932022-06-292680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206976-001113445202035-02-20U-33932022-06-295bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206976-001113511332035-02-20U-33932022-06-295bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206976-001113445202035-02-20U-33932022-06-29d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206976-001113511332035-02-20U-33932022-06-29d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206976-001113445202035-02-20U-33932022-06-29d06236e962d9…
2024-10-29 15:01 UTC2024-10N206976-001113511332035-02-20U-33932022-06-29d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206976-001113445202035-02-20U-33932022-06-2979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206976-001113511332035-02-20U-33932022-06-2979d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206976-001113445202035-02-20U-33932022-06-29301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206976-001113511332035-02-20U-33932022-06-29301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206976-001113445202035-02-20U-33932022-06-291e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206976-001113511332035-02-20U-33932022-06-291e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206976-001113445202035-02-20U-33932022-06-298072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206976-001113511332035-02-20U-33932022-06-298072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206976-001113445202035-02-20U-33932022-06-296a51e52b5d6a…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N206976-001113511332035-02-20U-33932022-06-296a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N206976-001113445202035-02-20U-33932022-06-291c564ffb4f44…
2024-02-18 07:12 UTC2024-02N206976-001113511332035-02-20U-33932022-06-291c564ffb4f44…
2023-12-20 04:57 UTC2023-12N206976-001113445202035-02-20U-33932022-06-29ea1830bbd6c7…
2023-12-20 04:57 UTC2023-12N206976-001113511332035-02-20U-33932022-06-29ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206976-001113445202035-02-20U-33932022-06-29a72a2bbeb626…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N206976-001113511332035-02-20U-33932022-06-29a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206976-001113445202035-02-20U-33932022-06-299b2671bbb829…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N206976-001113511332035-02-20U-33932022-06-299b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206976-001113445202035-02-20U-33932022-06-29a67488948f0b…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N206976-001113511332035-02-20U-33932022-06-29a67488948f0b…

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
CapturedEditionApplication-productExclusivity codeExpirationSource SHA-256
2019-12-13 00:20 UTC2019-12N206976-001NP2021-12-1974a2ff9319b5…
2021-12-28 21:50 UTC2021-12N206976-001NP2021-12-19782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N206976-001NP2021-12-1987673890dc5c…
2021-03-12 10:30 UTC2021-03N206976-001NP2021-12-195aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N206976-001NP2021-12-198869cabd3fbd…
2020-11-12 02:37 UTC2020-11N206976-001NP2021-12-19c0c555d07b60…
2019-12-14 00:12 UTC2019-12N206976-001NP2021-12-193f01610625f2…
2019-09-15 20:21 UTC2019-09N206976-001NP2021-12-19b00525d2431f…
2019-07-19 19:46 UTC2019-07N206976-001NP2021-12-19ea99ee380514…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206976-001NPP2029-03-27a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
LICART
Listing expiration
2027-12-31

Active Ingredients#

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

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
X5F8EKL9ZGInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2372911Internal RxNorm lookup
2385117Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
851c8b39-6056-4bbc-812e-b9b13977c1acAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fac74f96-3910-44b9-8551-036880fbb1fbProduct name120260108
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
2c999b01-2a13-4eff-8eb4-00b87316ef79Product name120231116
855d63c3-b090-4636-8fc7-6d39ad23c44fProduct name120230829
bb58f410-04be-65dd-9211-e89ead899698Product name620230323
0fcbc38a-8b29-3348-1cef-5222ea53484fProduct name420220516
c4e1eedc-aca2-4551-8382-89144ed9d049Product name320220126
8d368a34-1453-43ea-828d-0dbcd72b8794Product name820210622
05193eb6-d122-ab0b-603b-d9dd92599836Product name220210204
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2e5437ef-ff80-c9c2-2f66-5b7c771080beProduct name920180201
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316
ae28a785-50d8-477d-a268-dffdfdd7504bProduct name120150305
0c878822-66ca-456d-c17d-0894b04fa473Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71858-0305-1LICART2 in 1 POUCHSYSTEM215
71858-0305-2LICART1 in 1 CARTONSYSTEM115
71858-0305-4LICART5 in 1 POUCHSYSTEM515
71858-0305-5LICART3 in 1 CARTONSYSTEM315

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71858-0305-2EA - Each71858-030504a16a93-66fb-454b-a738-4cbb3773b48a12020-07-13
71858-0305-4EA - Each71858-0305a13300d9-a67f-4ce6-b09e-a6272dc160de12020-07-13
71858-0305-5EA - Each71858-0305004b98cd-9034-45b7-a4d7-36783d01390a12020-07-13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71858-0305LICART (DICLOFENAC EPOLAMINE) SYSTEM [IBSA PHARMA INC.]13Current NDC, Legacy NDC, 4 package rows20241201_851c8b39-6056-4bbc-812e-b9b13977c1ac.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.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
LICARTDICLOFENAC EPOLAMINEIBSA Pharma Inc.851c8b39-6056-4bbc-812e-b9b13977c1ac2026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (NDA): 206976
application number: NDA206976
ndc (product): 71858-0305

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2385117diclofenac epolamine 1.3 % Once-Daily Medicated PatchPSN851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Licart 1.3 % Once-Daily Medicated PatchPSN851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Once-Daily diclofenac epolamine 0.013 MG/MG Medicated Patch [Licart]SBD851c8b39-6056-4bbc-812e-b9b13977c1ac15
2385117Once-Daily diclofenac epolamine 0.013 MG/MG Medicated PatchSCD851c8b39-6056-4bbc-812e-b9b13977c1ac15
2385117diclofenac epolamine 1.3 % Once-Daily Medicated PatchSY851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Licart 1.3 % Once-Daily Medicated PatchSY851c8b39-6056-4bbc-812e-b9b13977c1ac15
2372911Once-Daily Licart 0.013 MG/MG Medicated PatchSY851c8b39-6056-4bbc-812e-b9b13977c1ac15

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71858-0305-1718580305012 in 1 POUCHHistorical
71858-0305-2718580305021 POUCH in 1 CARTON (71858-0305-2) / 2 SYSTEM in 1 POUCH (71858-0305-1) 1 pouch2020-09-010000-00-00YesNoCurrent
71858-0305-4718580305045 in 1 POUCHHistorical
71858-0305-5718580305053 POUCH in 1 CARTON (71858-0305-5) / 5 SYSTEM in 1 POUCH (71858-0305-4) 3 pouch2020-09-010000-00-00NoNoCurrent