Diclofenac Sodium

Manufacturer
Central Packaging | Central Packaging, LLC
Effective date
2021-02-24
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 20:35:42

Label at a glance#

ProductDiclofenac Sodium
Active ingredientDICLOFENAC SODIUM
Label structure3 sections

Label contents#

Full prescribing information#

DOSAGE & ADMINISTRATION SECTION

Solution - A clear, homogeneous liquid1 dosage form that contains one or more chemical substances dissolved in a solvent or mixture of mutually miscible solvents.

Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.

SPL MEDGUIDE SECTION

Medication Guide for Nonsteroidal Anti-inflammatory Drugs (NSAIDs) What is the most important information I should know about medicines called Nonsteroidal Anti-inflammatory Drugs (NSAIDs)? NSAIDs can cause serious side effects, including: Increased risk of a heart attack or stroke that can lead to death. This risk may happen early in treatment and may increase: with increasing doses of NSAIDs with longer use of NSAIDs Do not take NSAIDs right before or after a heart surgery called a "coronary artery bypass graft (CABG)." Avoid taking NSAIDs after a recent heart attack, unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack. Increased risk of bleeding, ulcers, and tears (perforation) of the esophagus (tube leading from the mouth to the stomach), stomach and intestines: anytime during use without warning symptoms that may cause death The risk of getting an ulcer or bleeding increases with: past history of stomach ulcers, or stomach or intestinal bleeding with use of NSAIDs taking medicines called "corticosteroids", "anticoagulants", "SSRIs", or "SNRIs" increasing doses of NSAIDs longer use of NSAIDs smoking drinking alcohol older age poor health advanced liver disease bleeding problems NSAIDs should only be used: exactly as prescribed at the lowest dose possible for your treatment for the shortest time needed What are NSAIDs? NSAIDs are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as different types of arthritis, menstrual cramps, and other types of short-term pain. Who should not take NSAIDs? Do not take NSAIDs: if you have had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAIDs. right before or after heart bypass surgery. Before taking NSAIDs, tell your healthcare provider about all of your medical conditions, including if you: have liver or kidney problems have high blood pressure have asthma are pregnant or plan to become pregnant. Talk to your healthcare provider if you are considering taking NSAIDs during pregnancy. You should not take NSAIDs after 29 weeks of pregnancy. are breastfeeding or plan to breast feed. Tell your healthcare provider about all of the medicines you take, including prescription or over-the-counter medicines, vitamins or herbal supplements. NSAIDs and some other medicines can interact with each other and cause serious side effects. Do not start taking any new medicine without talking to your healthcare provider first. What are the possible side effects of NSAIDs? NSAIDs can cause serious side effects, including: See "WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT MEDICINES CALLED NONSTEROIDAL ANTI-INFLAMMATORY DRUGS (NSAIDS)?" new or worse high blood pressure liver problems including liver failure low red blood cells (anemia) life-threatening allergic reactions heart failure kidney problems including kidney failure life-threatening skin reactions Other side effects of NSAIDs include: stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting, and dizziness. Get emergency help right away if you get any of the following symptoms: shortness of breath or trouble breathing chest pain weakness in one part or side of your body slurred speech swelling of the face or throat Stop taking your NSAID and call your healthcare provider right away if you get any of the following symptoms: nausea more tired or weaker than usual diarrhea itching your skin or eyes look yellow indigestion or stomach pain flu-like symptoms vomit blood there is blood in your bowel movement or it is black and sticky like tar unusual weight gain skin rash or blisters with fever swelling of the arms, legs, hands and feet If you take too much of your NSAID, call your healthcare provider or get medical help right away. These are not all the possible side effects of NSAIDs. For more information, ask your healthcare provider or pharmacist about NSAIDs. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. Other information about NSAIDs Aspirin is an NSAID but it does not increase the chance of a heart attack. Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines. Some NSAIDs are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days. General information about the safe and effective use of NSAIDs Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use NSAIDs for a condition for which it was not prescribed. Do not give NSAIDs to other people, even if they have the same symptoms that you have. It may harm them. If you would like more information about NSAIDs, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about NSAIDs that is written for health professionals. Manufactured by: Taro Pharmaceuticals Inc., Brampton, Ontario, Canada L6T 1C1 Distributed by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 Revised: July 2019 PK-6853-2 56 For more information, call 1-866-923-4914

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Diclofenac SodiumDiclofenac Sodium

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
857700diclofenac sodium 1.5 % Topical SolutionPSN1
857700diclofenac sodium 15 MG/ML Topical SolutionSCD1
857700diclofenac sodium 1.5 % (as diclofenac sodium 16.05 MG/ML) Topical SolutionSY1
857700diclofenac sodium 16.05 MG per 1 ML Topical SolutionSY1

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80175-1358-0Diclofenac Sodium1 in 1 CARTONSOLUTION11
80175-1358-0Diclofenac Sodium150 mL in 1 BOTTLE, DROPPERSOLUTION1501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80175-1358DICLOFENAC SODIUM SOLUTION [CENTRAL PACKAGING]1Legacy NDC, 2 package rows20210225_bc185822-4754-ff6c-e053-2995a90a7c0e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-1358-2ML - Milliliter51672-13583cbc277c-c918-43ae-bce6-4cff117c87f912015-04-03

Products#

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

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
80175-135880175-1358-0
51672-1358

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

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
A203818-001DICLOFENAC SODIUMDICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
A203818-001AT

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.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2684e616aacf4f…
2026-08-18 06:07:402026-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2631067a03dcf5…
2025-08-23 18:47 UTC2025-08A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-266a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-262680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-261e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-268072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-264b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-2674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-2687673890dc5c…
2021-03-12 10:30 UTC2021-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-265aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-268869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-26c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-263f01610625f2…
2019-09-15 20:21 UTC2019-09A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-26b00525d2431f…
2019-07-19 19:46 UTC2019-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALAT2014-11-26ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-266a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-261c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-269b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-263f0d92c62455…
2023-05-13 08:27 UTC2023-05A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26053a50430f4f…
2023-01-26 05:58 UTC2023-01A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-263bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-263a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203818-001DICLOFENAC SODIUM1.5%SOLUTION / TOPICALATRS2014-11-26f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08A203818-001AT184e616aacf4f…
2026-08-18 06:07:402026-07A203818-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A203818-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A203818-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08A203818-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A203818-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A203818-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A203818-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A203818-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A203818-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A203818-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A203818-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A203818-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A203818-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A203818-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05A203818-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A203818-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A203818-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A203818-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A203818-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03A203818-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A203818-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A203818-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03A203818-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A203818-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11A203818-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12A203818-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09A203818-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07A203818-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A203818-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A203818-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12A203818-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A203818-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A203818-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A203818-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A203818-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05A203818-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01A203818-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A203818-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A203818-001AT1f41ea6bd6efb…

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Diclofenac SodiumDICLOFENAC SODIUMSun Pharmaceutical Industries, Inc.fae53d24-acf1-4250-888d-b8d965ffc3d32026-02-18Boxed warning, Warnings, Adverse reactionsExact identifier
ndc (product): 51672-1358
bc185822-4755-ff6c-e053-2995a90a7c0ebc185822-4754-ff6c-e053-2995a90a7c0e2021-02-24Exact identifier
spl id: bc185822-4755-ff6c-e053-2995a90a7c0e
spl set id: bc185822-4754-ff6c-e053-2995a90a7c0e

Reported adverse events (FAERS/openFDA)#

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