FDA.reportPublic FDA data

Diclofenac sodium

Product NDC
49035-269
11-digit product format
490350269
Labeler code
49035
Product ID
49035-269_6657f28e-6f37-4499-9695-bcded504f1b6
Type
HUMAN OTC DRUG
Nonproprietary name
Diclofenac sodium
Dosage form
GEL
Route
TOPICAL
Labeler
EQUATE (Wal-Mart Stores, Inc.) (see also WAL-MART INC)
Application
ANDA208077
Marketing category
ANDA
Marketing start
2021-05-03
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
Listing certified through
2026-12-31
Current FDA listing
Yes

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 Identifiers#

Field, Values table
FieldValues
UniiQTG126297Q
Rxcui855633

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
49035-269-17Diclofenac sodium1 in 1 CARTONGEL112
49035-269-17Diclofenac sodium50 g in 1 TUBEGEL5012
49035-269-35Diclofenac sodium100 g in 1 TUBEGEL10012
49035-269-35Diclofenac sodium1 in 1 CARTONGEL112
49035-269-53Diclofenac sodium1 in 1 CARTONGEL112
49035-269-53Diclofenac sodium150 g in 1 TUBEGEL15012

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49035-269-17GM - Gram49035-2697ff42370-8d04-4ad3-a2cc-9e7b93e7e2d912023-03-13
49035-269-35GM - Gram49035-269b049494c-46ed-4948-91b6-6d559547a97712024-03-12
49035-269-53GM - Gram49035-2699527b5e9-bdd3-4982-9f38-289185d4fbdb12024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-269DICLOFENAC SODIUM GEL [EQUATE (WAL-MART STORES, INC.) (SEE ALSO WAL-MART INC)]12Current NDC, Legacy NDC, 6 package rows20230222_2a7019e9-e20f-4897-9b8e-942a7f2b34f6.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
855633diclofenac sodium 1 % Topical GelPSN2a7019e9-e20f-4897-9b8e-942a7f2b34f612
855633diclofenac sodium 0.01 MG/MG Topical GelSCD2a7019e9-e20f-4897-9b8e-942a7f2b34f612
855633diclofenac sodium 1 % Topical GelSY2a7019e9-e20f-4897-9b8e-942a7f2b34f612

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
49035-269-17490350269171 TUBE in 1 CARTON (49035-269-17) / 50 g in 1 TUBE1 tube2021-05-030000-00-00NoNoCurrent
49035-269-35490350269351 TUBE in 1 CARTON (49035-269-35) / 100 g in 1 TUBE1 tube2021-05-03NoNoHistorical
49035-269-53490350269531 TUBE in 1 CARTON (49035-269-53) / 150 g in 1 TUBE1 tube2021-05-03NoNoHistorical