FDA.reportPublic FDA data

3% Diclofenac Spray, 118ml

Manufacturer
Shoreline Pharmaceuticals, Inc.
Effective date
2016-03-10
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 20:22:04

Label at a glance#

ProductDiclofenac Sodium
Active ingredientDICLOFENAC SODIUM
Label structure2 sections

Label contents#

Full prescribing information#

GENERAL PRECAUTIONS SECTION

Diclofenac sodium 3% spray

Use as directed.

Qty 118

No refills

Shoreline Pharmaceuticals, Inc.

16530 Ventura Blvd, Suite 610

Encino, CA 91436

310.464.9170

Rx 616194

N Dr:

Date

Discard by

For External Use Only

Compounded by Shoreline Pharmaceuticals

Toll Free: 877-817-1885

You may report side effects to FDA at 1-800-FDA-1088

NDC69621-300-10

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC69621-300-10NDC69621-300-10

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69621-300-012020-01-31C16284748780-19d75b9cf-db6b-f424-e053-dadaa90a57ce3% Diclofenac Spray, 118ml

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69621-300-01Diclofenac Sodium1 mL in 1 BOTTLE, SPRAYAEROSOL, METERED13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69621-300DICLOFENAC SODIUM (3% DICLOFENAC SPRAY) AEROSOL, METERED [SHORELINE PHARMACEUTICALS, INC.]3Legacy NDC, 1 package rows20160311_278748fb-a004-4802-e054-00144ff8d46c.zip

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69621-30069621-300-01

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
DICLOFENAC SODIUMQTG126297QACTIB

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
2db8f138-1910-179e-e054-00144ff8d46c278748fb-a004-4802-e054-00144ff8d46c2016-03-10Exact identifier
spl id: 2db8f138-1910-179e-e054-00144ff8d46c
spl set id: 278748fb-a004-4802-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

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