FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
63981-211
11-digit product format
639810211
Labeler code
63981
Product ID
63981-211_9954b340-4783-4387-a9da-2f36b4cf8089
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
Costco Wholesale
Application
ANDA208077
Marketing category
ANDA
Marketing start
2022-12-31
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
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
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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-01 22:54:322026-06A208077-001DICLOFENAC SODIUM1%GEL / TOPICAL2016-03-18a50c72e98297…

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated 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
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
ndc (product): 63981-211
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

Additional Listing Data#

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

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
141b6693-6d6c-45c6-9b82-ee1afcfca12aAvailable 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
63981-211-15Diclofenac sodium150 g in 1 TUBEGEL1501
63981-211-15Diclofenac sodium3 in 1 CARTONGEL31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63981-211DICLOFENAC SODIUM GEL [COSTCO WHOLESALE]1Current NDC, 2 package rows20230129_141b6693-6d6c-45c6-9b82-ee1afcfca12a.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN141b6693-6d6c-45c6-9b82-ee1afcfca12a1
855633diclofenac sodium 0.01 MG/MG Topical GelSCD141b6693-6d6c-45c6-9b82-ee1afcfca12a1
855633diclofenac sodium 1 % Topical GelSY141b6693-6d6c-45c6-9b82-ee1afcfca12a1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
63981-211-15639810211153 TUBE in 1 CARTON (63981-211-15) / 150 g in 1 TUBE3 tube2022-12-31NoNoCurrent