FDA.reportPublic FDA data

Diclofenac Sodium

Product NDC
76420-861
11-digit product format
764200861
Labeler code
76420
Product ID
76420-861_239fc4df-8f2c-e524-e063-6394a90a2bae
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Diclofenac Sodium
Dosage form
SOLUTION
Route
TOPICAL
Labeler
Asclemed USA, Inc
Application
ANDA213040
Marketing category
ANDA
Marketing start
2023-02-03
Substance
DICLOFENAC SODIUM
Active strength
20 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
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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A213040-001DICLOFENAC SODIUMDICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A213040-001AB

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-02-19 14:30 UTC2026-02A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-0331067a03dcf5…
2025-08-23 18:47 UTC2025-08A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-036a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-0303ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-032680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-035bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-0379d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-031e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-038072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-036a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-031c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-039b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-033f0d92c62455…
2023-05-13 08:27 UTC2023-05A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213040-001DICLOFENAC SODIUM2%SOLUTION / TOPICALAB2023-02-03a50c72e98297…

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-02-19 14:30 UTC2026-02A213040-001AB1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A213040-001AB131067a03dcf5…
2025-08-23 18:47 UTC2025-08A213040-001AB16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A213040-001AB1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A213040-001AB1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A213040-001AB103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A213040-001AB12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A213040-001AB15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A213040-001AB1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A213040-001AB1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A213040-001AB179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A213040-001AB1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A213040-001AB11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A213040-001AB18072bd15b7f6…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A213040-001AB16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A213040-001AB11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A213040-001AB1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A213040-001AB1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A213040-001AB19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A213040-001AB1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A213040-001AB13f0d92c62455…
2023-05-13 08:27 UTC2023-05A213040-001AB1053a50430f4f…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06A213040-001AB1a50c72e98297…

Additional Listing Data#

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DICLOFENAC SODIUM20 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
1487074Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2e3e6de9-7e07-4df3-9fea-ac50ddcde840Available 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
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
76420-861-04Diclofenac Sodium112 g in 1 BOTTLESOLUTION1121
76420-861-04Diclofenac Sodium1 in 1 CARTONSOLUTION11

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-861-04GM - Gram76420-86144807c34-6a88-4a47-8f6f-0125ae353cc512025-01-14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-861DICLOFENAC SODIUM SOLUTION [ASCLEMED USA, INC]1Current NDC, 2 package rows20241127_2e3e6de9-7e07-4df3-9fea-ac50ddcde840.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 · 8 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMAurolife Pharma LLCdfb7afdf-5c05-4487-9044-936e151e5ba62026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
Diclofenac SodiumDICLOFENAC SODIUMPreferred Pharmaceuticals Inc.15b280a1-4964-4636-833b-3db44044d2892026-04-02Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
Diclofenac SodiumDICLOFENAC SODIUMA-S Medication Solutionsca0f9295-4933-48d6-9387-90345fd5dcaa2025-08-20Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
Diclofenac SodiumDICLOFENAC SODIUMNorthStar Rx LLCfd467c1a-6463-4d92-9960-3e308c733edb2025-01-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPba4677e4-00f8-44f6-a69b-e88ca28f6b2b2024-11-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
Diclofenac SodiumDICLOFENAC SODIUMAsclemed USA, Inc2e3e6de9-7e07-4df3-9fea-ac50ddcde8402024-10-04Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
ndc (product): 76420-861
Diclofenac Sodium Topical SolutionDICLOFENAC SODIUM TOPICAL SOLUTIONDirect_Rx15c2cd6d-b7c2-d927-e063-6394a90aa63e2024-04-10Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040
Diclofenac SodiumDICLOFENAC SODIUMProficient Rx LPf104f8fb-066f-4bbf-8894-3b3ed1b8266d2024-03-01Boxed warning, Warnings, Adverse reactionsExact identifier
application applno (ANDA): 213040
application number: ANDA213040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1487074diclofenac sodium 2 % Topical SolutionPSN2e3e6de9-7e07-4df3-9fea-ac50ddcde8401
1487074diclofenac sodium 20 MG/ML Topical SolutionSCD2e3e6de9-7e07-4df3-9fea-ac50ddcde8401
1487074diclofenac sodium 2 % Topical SolutionSY2e3e6de9-7e07-4df3-9fea-ac50ddcde8401

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
76420-861-04764200861041 BOTTLE in 1 CARTON (76420-861-04) / 112 g in 1 BOTTLE1 bottle2024-10-04NoNoCurrent