DICLOFENAC SODIUM

Product NDC: 85534-0089
Requested package NDC: 85534-0089-0
11-digit product format: 855340089
Labeler code: 85534
Product ID: 85534-0089_566cbcc2-290d-9b1f-e063-6294a90a9c2e
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: diclofenac sodium
Dosage form: GEL
Route: TOPICAL
Labeler: HAWAII REPACK, INC
Application: ANDA208301
Marketing category: ANDA
Marketing start: 2016-09-13
Substance: DICLOFENAC SODIUM
Active strength: 30 mg/g
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
A208301-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB		2016-09-13

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A208301-001	AB

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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208301-001	DICLOFENAC SODIUM	3%	GEL / TOPICAL	AB	2016-09-13	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A208301-001	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A208301-001	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A208301-001	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A208301-001	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A208301-001	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A208301-001	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A208301-001	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A208301-001	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A208301-001	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A208301-001	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A208301-001	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A208301-001	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A208301-001	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A208301-001	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A208301-001	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A208301-001	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A208301-001	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A208301-001	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A208301-001	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A208301-001	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A208301-001	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A208301-001	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A208301-001	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A208301-001	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A208301-001	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A208301-001	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A208301-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A208301-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A208301-001	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A208301-001	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A208301-001	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A208301-001	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A208301-001	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A208301-001	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A208301-001	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A208301-001	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A208301-001	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A208301-001	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A208301-001	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A208301-001	AB	1	`f41ea6bd6efb…`

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	30 mg/g

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
855642	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
ea113a58-c7ed-4768-9777-93d9b166dfbe	Available on FDA.report

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 · 9 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DICLOFENAC SODIUM	DICLOFENAC SODIUM	HAWAII REPACK, INC	ea113a58-c7ed-4768-9777-93d9b166dfbe	2026-07-12	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301 ndc (package): 85534-0089-0 ndc (product): 85534-0089 ndc11 (package): 85534008900
DICLOFENAC SODIUM	DICLOFENAC SODIUM	REMEDYREPACK INC.	96f8c42c-db34-43b0-a891-33dd8e39e74f	2026-04-08	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Preferred Pharmaceuticals Inc.	5d0a4b41-afbf-45e7-bb1c-587d72314ee0	2026-04-02	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
Diclofenac Sodium Gel	DICLOFENAC SODIUM GEL	Direct_Rx	e82e4d34-bdaa-b950-e053-2995a90a29f1	2026-03-17	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	NuCare Pharmaceuticals,Inc.	06862cf2-9537-6661-e063-6294a90a2084	2026-02-16	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	GLENMARK PHARMACEUTICALS INC., USA	dab3ae60-0135-43b3-a1d0-8752720af82a	2025-10-27	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
Diclofenac Sodium	DICLOFENAC SODIUM	Advanced Rx Pharmacy of Tennessee, LLC	f1892aae-7267-3b4c-e053-2995a90a8802	2024-12-31	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Proficient Rx LP	f19bf286-f4dd-4491-90c3-9f8713071903	2023-12-01	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301
DICLOFENAC SODIUM	DICLOFENAC SODIUM	Asclemed USA, Inc.	57d8513a-820a-46c5-b0c8-5aa1811b0e88	2020-10-30	Boxed warning, Warnings, Adverse reactions	Exact identifier application applno (ANDA): 208301 application number: ANDA208301

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
QTG126297Q	DICLOFENAC SODIUM	15307-79-6	DICLOFENAC SODIUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
85534-0089-0	85534008900	1 TUBE in 1 CARTON (85534-0089-0) / 100 g in 1 TUBE	1 tube	2026-07-12	No	No	Current