Diclofenac sodium

Product NDC
21130-028
11-digit product format
211300028
Labeler code
21130
Product ID
21130-028_bcc10716-da68-4299-b95c-5222c7d46c1b
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Safeway, Inc.
Application
ANDA208077
Marketing category
ANDA
Marketing start
2021-05-03
Marketing end
2027-05-03
Substance
DICLOFENAC SODIUM
Active strength
10 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
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
A208077-001DICLOFENAC SODIUMDICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18

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 UTC2026-02A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1831067a03dcf5…
2025-08-23 18:47 UTC2025-08A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-186a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-182680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-181e350fbaab3a…
2024-05-31 18:47 UTC2024-05A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-188072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-184b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-1874a2ff9319b5…
2022-03-09 01:35 UTC2022-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-1887673890dc5c…
2021-03-12 10:30 UTC2021-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-185aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-188869cabd3fbd…
2020-11-12 02:37 UTC2020-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18c0c555d07b60…
2019-12-14 00:12 UTC2019-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-183f01610625f2…
2019-09-15 20:21 UTC2019-09A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-18b00525d2431f…
2019-07-19 19:46 UTC2019-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICALAB2016-03-18ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-186a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-181c564ffb4f44…
2023-12-20 04:57 UTC2023-12A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-189b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-183f0d92c62455…
2023-05-13 08:27 UTC2023-05A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18053a50430f4f…
2023-01-26 05:58 UTC2023-01A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-183bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-183a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18f41ea6bd6efb…
2022-09-29 23:25 UTC2022-09A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18cb3db0bc1861…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2019-12-13 00:20 UTC2019-12A208077-001AB174a2ff9319b5…
2019-12-14 00:12 UTC2019-12A208077-001AB13f01610625f2…
2019-09-15 20:21 UTC2019-09A208077-001AB1b00525d2431f…
2019-07-19 19:46 UTC2019-07A208077-001AB1ea99ee380514…

Additional Listing Data#

Finished product
Yes
Brand name base
Diclofenac sodium

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM10 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
QTG126297QInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
855633Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
196d8af7-739f-4d2c-8c4e-9d33e6d722abAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
111d457e-3138-4512-b0ba-d0cd760c4055Product name320250225
0426261e-1bb9-b78b-abd2-80da765a7e3eProduct name220240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7Product name520240320
0ac2f11f-f58d-baf2-71a0-680993b48a61Product name220231211
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
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
d6bab9d2-edce-a213-4796-226ab15472c3Product name620200616
2487e6ef-d419-42fc-aaf8-7acc805d2370Product name220170718
e071c814-e5e7-e7ed-ec76-428765d9c66bProduct name220151120
93148e06-b8d7-4e6c-853e-62f807d17fbbProduct name120151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247eProduct name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-028-10Diclofenac sodium1 in 1 CARTONGEL17
21130-028-10Diclofenac sodium100 g in 1 TUBEGEL1007
21130-028-50Diclofenac sodium50 g in 1 TUBEGEL507
21130-028-50Diclofenac sodium1 in 1 CARTONGEL17

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-028DICLOFENAC SODIUM GEL [SAFEWAY, INC.]5Current NDC, Legacy NDC, 4 package rows20240920_196d8af7-739f-4d2c-8c4e-9d33e6d722ab.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 2 · 21 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac sodiumDICLOFENAC SODIUMCVS Pharmacy591cc2ed-e667-4779-a426-8a2e6f8735732026-07-22WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMCARDINAL HEALTH 110, LLC. DBA LEADER 70000081b43f9-f594-4b1e-8564-7dbbea6fa5bd2026-05-26WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMWalgreens33a37e3d-0463-428c-9169-240eeb77af2b2026-04-21WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMRugby Laboratories95f3c70c-eded-4d24-b9b0-cfa0b7902d6e2026-02-10WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMFamily Dollar (FAMILY WELLNESS)03ddf347-a3a3-4313-87d1-a246c1d4e0b42026-01-29WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMSportpharm LLCac631742-119f-408a-8b36-b041bab743e22026-01-14WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMQUALITY CHOICE (Chain Drug Marketing Association)98f94aa2-6bc2-4c07-81c8-63b2c262cf392026-01-06WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMSafeway, Inc.196d8af7-739f-4d2c-8c4e-9d33e6d722ab2025-12-23WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
ndc (product): 21130-028
Diclofenac sodiumDICLOFENAC SODIUMBest Choice (Valu Merchandisers Company)4ea809a9-387a-4193-a176-d8b22eaa55e62025-08-21WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMChain Drug Consortium, LLC8879a2ed-6c66-4489-8adc-9f160241cc7d2025-06-25WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENACScholl's Wellness Company8dcbce69-945b-4913-a279-ee10871f65802024-11-14WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
SalonpasDICLOFENAC SODIUMHisamitsu America, Inc.f439445d-046e-4220-a4a7-13d750ee09492024-11-14WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENACAmneal Pharmaceuticals NY LLC1084e0c3-6d75-4090-84dc-02a18e0299b92023-12-29WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMCare One (Retail Business Services, LLC.)4484a332-aab1-46a9-aca8-159e7a09439f2023-11-17WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMCVS PHARMACY, INC4808015d-cfee-4f4d-a84b-82099f0b48682023-10-04WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMAmerisourceBergen (Good Neighbor Pharmacy) 4612230e1f589-b322-48b7-9a97-502afe2a1baa2023-08-09WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMEQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)2a7019e9-e20f-4897-9b8e-942a7f2b34f62023-02-21WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMCostco Wholesale141b6693-6d6c-45c6-9b82-ee1afcfca12a2023-01-27WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Arthritis Pain RelieverDICLOFENAC SODIUMP & L Development, LLC2596645a-b736-4d3c-82a0-00713f1b6fbd2022-12-15WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077
Diclofenac sodiumDICLOFENAC SODIUMCostco Wholesaledbe33463-fa5c-4dc9-9d98-4d553fa434652022-10-11WarningsExact identifier
application applno (ANDA): 208077
application number: ANDA208077

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN196d8af7-739f-4d2c-8c4e-9d33e6d722ab7
855633diclofenac sodium 0.01 MG/MG Topical GelSCD196d8af7-739f-4d2c-8c4e-9d33e6d722ab7
855633diclofenac sodium 1 % Topical GelSY196d8af7-739f-4d2c-8c4e-9d33e6d722ab7

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-028-10211300028101 TUBE in 1 CARTON (21130-028-10) / 100 g in 1 TUBE1 tube2021-05-032027-05-03NoNoCurrent
21130-028-50211300028501 TUBE in 1 CARTON (21130-028-50) / 50 g in 1 TUBE1 tube2021-05-032027-05-03NoNoCurrent