FDA.reportPublic FDA data

Diclofenac Sodium

Manufacturer
Two Hip Consulting, LLC
Effective date
2019-02-06
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 20:27:45

Label at a glance#

ProductDiclofenac Sodium
Active ingredientDICLOFENAC SODIUM
Label structure6 sections

Label contents#

Full prescribing information#

INDICATIONS & USAGE SECTION

INDICATIONS: For the topical treatmentof active keratosis.

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

HYALURONATE SODIU, BENZYL ALCOHOL, POLYETHYLENE GLYCOL MONOMETHYL ETHER, PURIFIED WATER.

USUAL ADULT DOSAGE

DOSAGE & ADMINISTRATION SECTION

0.5G OF GEL (SIZE OF A PEA APPLIED TO AFFECTED AREA AND SMOOTHED INTO SKIN GENTLY, OR AS DIRECTED BY YOUR PHYSICIAN. THE USUAL DURATION OF THERAPY IS FROM 60 TO 90 DAYS.

WARNING

WARNINGS SECTION

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

OTHER SAFETY INFORMATION

Please see package insert for full prescribing information. Store at 20 to 25 degrees C (68 to 77 degrees F): excursions permitted to 15 – 30 C (59 – 86 degrees F) Protect from heat. Avoid freezing. See crimp of tube and/or carton for lot number and expiration date.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Medi-Sulting-Diclofenac Label Rx NDC-1Medi-Sulting-Diclofenac Label Rx NDC-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
855642diclofenac sodium 3 % Topical GelPSN4
855642diclofenac sodium 0.03 MG/MG Topical GelSCD4
855642diclofenac sodium 3 % Topical GelSY4

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DICLOFENAC Pharmacologic Class Indexing2Indexing - Pharmacologic Class20190118

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
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
76074-501-112021-01-29C16284748780-1ba0f9c33-0fcd-a910-e053-dadaa90a0b8544b76125-05bd-42fe-a3e8-1d8ec39984e5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76074-501-11Diclofenac Sodium100 g in 1 TUBEGEL1004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76074-501DICLOFENAC SODIUM GEL [TWO HIP CONSULTING, LLC]4Legacy NDC, 1 package rows20190207_44b76125-05bd-42fe-a3e8-1d8ec39984e5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76074-501-11GM - Gram76074-5010fbb1db6-9c89-46dc-a5e3-d61a16e2eb9012016-06-14

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76074-50176074-501-11

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
DICLOFENAC SODIUMQTG126297QACTIB
HYALURONATE SODIUMYSE9PPT4THIACT
BENZYL ALCOHOLLKG8494WBHIACT
METHOXY PEG-406AXS45P1QUIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
b4e24953-24ad-4bbd-8ed0-21484936a84344b76125-05bd-42fe-a3e8-1d8ec39984e52019-02-06WarningsExact identifier
spl id: b4e24953-24ad-4bbd-8ed0-21484936a843
spl set id: 44b76125-05bd-42fe-a3e8-1d8ec39984e5

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.