MOTRIN ARTHRITIS PAIN

Manufacturer: Kenvue Brands LLC
Effective date: 2024-11-08
Label type: HUMAN OTC DRUG LABEL
Version: 10
Source: full-release
Hydrated at: 2026-06-01 00:36:18

Label at a glance#

ProductMOTRIN ARTHRITIS PAIN

Active ingredientDICLOFENAC SODIUM

Label structure10 sections

Indications and uses

for the temporary relief of arthritis pain ONLY in the following areas: hand, wrist, elbow (upper body areas) foot, ankle, knee (lower body areas) this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Dosage and administration

Use up to 21 days unless directed by your doctor Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries. Daily Per Dose For your arthritis pain: Use 4 times per day every day Do not use on more than 2 body areas at the same time Use ENCLOSED DOSING CARD to measure a dose For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 ...

Storage and handling

store at 20-25°C (68-77°F). Keep from freezing. read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-962-5357

PhoneLabel contact215-273-8755

Websitewww.motrin.com

www.motrin.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Diclofenac sodium (NSAID*) 1% (equivalent to 0.93% diclofenac)

*nonsteroidal anti-inammatory drug

Purpose

OTC - PURPOSE SECTION

Arthritis pain reliever

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of arthritis pain ONLY in the following areas:
hand, wrist, elbow (upper body areas)
foot, ankle, knee (lower body areas)
this product may take up to 7 days to work for arthritis pain; it is not for immediate relief. If no pain relief in 7 days, stop use.

Warnings

WARNINGS SECTION

For external use only

Allergy alert

SPL UNCLASSIFIED SECTION

Diclofenac may cause a severe allergic reaction, especially in people allergic to aspirin.

Symptoms may include:

hives
asthma (wheezing)
skin reddening
blisters
facial swelling
shock
rash

If an allergic reaction occurs, stop use and seek medical help right away.

Liver warning

SPL UNCLASSIFIED SECTION

This product contains diclofenac. Liver damage may occur if you apply

more or for a longer time than directed
when using other drugs containing diclofenac

Stomach bleeding warning

SPL UNCLASSIFIED SECTION

This product contains an NSAID, which may cause severe stomach bleeding. The chance is small but higher if you

are age 60 or older
have had stomach ulcers or bleeding problems
take a blood thinning (anticoagulant) or steroid drug
take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others)
have 3 or more alcoholic drinks every day while using this product
apply more or for longer than directed

Heart attack and stroke warning

SPL UNCLASSIFIED SECTION

NSAIDs, except aspirin, increase the risk of heart attack, heart failure, and stroke. These can be fatal. The risk is higher if you use more than directed or for longer than directed.

Do not use

OTC - DO NOT USE SECTION

if you have ever had an allergic reaction to any other pain reliever or to a fever reducer
for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.
right before or after heart surgery
on more than 2 body areas at the same time
in the eyes, nose or mouth

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you have problems or serious side effects from taking pain relievers or fever reducers
stomach bleeding warning applies to you
you have a history of stomach problems, such as heartburn
you have high blood pressure, heart disease, liver cirrhosis, kidney disease, asthma, or had a stroke
you are taking a diuretic
you are under age 18 years. It is not known if this drug works or is safe in children under age 18 years.

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

under a doctor’s care for any serious condition
taking any other drug

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes, nose, or mouth
if eye contact occurs, rinse thoroughly with water

Stop use and ask a doctor if

OTC - STOP USE SECTION

pain gets worse or lasts more than 21 days
redness or swelling is present in the painful area
fever occurs
skin irritation occurs
any new symptoms appear. These could be signs of a serious condition.
you experience any of the following signs of stomach bleeding:
feel faint
have bloody or black stools
vomit blood
have stomach pain that does not get better
you have symptoms of heart problems or stroke:
chest pain
trouble breathing
leg swelling
weakness in one part or side of body
slurred speech

If pregnant or breast-feeding,

OTC - DO NOT USE SECTION

ask a health professional before use. It is especially important not to use diclofenac at 20 weeks or later in pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

Use up to 21 days unless directed by your doctor

Not for strains, sprains, bruises or sports injuries. This product has not been shown to work for these types of injuries.

Daily

Per Dose

For your arthritis pain:

Use 4 times per day every day
Do not use on more than 2 body areas at the same time

Use ENCLOSED DOSING CARD to measure a dose

For each upper body area (hand, wrist, or elbow) – Squeeze out 2.25 inches (2 grams)
For each lower body area (foot, ankle or knee) – Squeeze out 4.5 inches (4 grams)

Read the enclosed User Guide for complete instructions:

use only as directed
do not use more than directed or for longer than directed
apply only to clean, dry skin that does not have any cuts, open wounds, infections or rashes
do not apply in same area as any other product
do not apply with external heat such as heating pad
do not apply a bandage over the treated area
store ENCLOSED DOSING CARD with your Motrin® Arthritis Pain product. The dosing card is re-usable.

Other information

STORAGE AND HANDLING SECTION

store at 20-25°C (68-77°F). Keep from freezing.
read all product information before using. Keep the dosing card, this carton and accompanying User Guide for important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer homopolymer Type C, cocoyl caprylocaprate, isopropyl alcohol, mineral oil, polyoxyl 20 cetostearyl ether, propylene glycol, purified water, strong ammonia solution

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-962-5357 (toll-free) or 215-273-8755 (collect) or visit www.motrin.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50580-574-02

Original

Prescription

Strength

New!

Different Ingredient
Diclofenac Sodium

Motrin ^®

ARTHRITIS PAIN

Diclofenac Sodium

Topical Gel, 1% (NSAID)

ARTHRITIS PAIN RELIEVER

Anti-inflammatory

For daily treatment of

arthritis pain

Fragrance

Free**

For external use only

NET WT. 3.53 OZ (100 g)

motrin-01

USER GUIDE

INSTRUCTIONS FOR USE SECTION

User Guide

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DICLOFENAC Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20190118

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
111d457e-3138-4512-b0ba-d0cd760c4055	Product name	3	20250225
0426261e-1bb9-b78b-abd2-80da765a7e3e	Product name	2	20240513
7b6158ae-c3f4-3d73-c35f-6f5d18b9efd7	Product name	5	20240320
0ac2f11f-f58d-baf2-71a0-680993b48a61	Product name	2	20231211
855d63c3-b090-4636-8fc7-6d39ad23c44f	Product name	1	20230829
bb58f410-04be-65dd-9211-e89ead899698	Product name	6	20230323
0fcbc38a-8b29-3348-1cef-5222ea53484f	Product name	4	20220516
c4e1eedc-aca2-4551-8382-89144ed9d049	Product name	3	20220126
8d368a34-1453-43ea-828d-0dbcd72b8794	Product name	8	20210622
d6bab9d2-edce-a213-4796-226ab15472c3	Product name	6	20200616
2487e6ef-d419-42fc-aaf8-7acc805d2370	Product name	2	20170718
e071c814-e5e7-e7ed-ec76-428765d9c66b	Product name	2	20151120
93148e06-b8d7-4e6c-853e-62f807d17fbb	Product name	1	20151014
dbb00be6-fb1c-4b0a-a770-31f7e05e247e	Product name	1	20150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50580-574-01	MOTRIN ARTHRITIS PAIN	50 g in 1 TUBE	GEL	50	10
50580-574-01	MOTRIN ARTHRITIS PAIN	1 in 1 CARTON	GEL	1	10
50580-574-02	MOTRIN ARTHRITIS PAIN	1 in 1 CARTON	GEL	1	10
50580-574-02	MOTRIN ARTHRITIS PAIN	100 g in 1 TUBE	GEL	100	10

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50580-574	MOTRIN ARTHRITIS PAIN (DICLOFENAC SODIUM) GEL [KENVUE BRANDS LLC]	10	Current NDC, Legacy NDC, 4 package rows	20241109_db5b4288-13ec-826b-e053-2995a90a275e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
50580-574-01	GM - Gram	50580-574	8682732e-fdd8-473e-add4-301dac76a123	1	2022-08-04
50580-574-02	GM - Gram	50580-574	ba8dba1f-69e0-4609-a996-138d330e3d4c	1	2022-08-04

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

MOTRIN ARTHRITIS PAIN
Diclofenac sodium
WATER
CARBOMER HOMOPOLYMER TYPE C
COCOYL CAPRYLOCAPRATE
ISOPROPYL ALCOHOL
AMMONIA
MINERAL OIL
POLYOXYL 20 CETOSTEARYL ETHER
PROPYLENE GLYCOL
DICLOFENAC

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
50580-574	50580-574-01, 50580-574-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
WATER	059QF0KO0R	IACT
CARBOMER HOMOPOLYMER TYPE C	4Q93RCW27E	IACT
COCOYL CAPRYLOCAPRATE	8D9H4QU99H	IACT
ISOPROPYL ALCOHOL	ND2M416302	IACT
AMMONIA	5138Q19F1X	IACT
MINERAL OIL	T5L8T28FGP	IACT
POLYOXYL 20 CETOSTEARYL ETHER	YRC528SWUY	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
DICLOFENAC SODIUM	QTG126297Q	ACTIB

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-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211253-001	DICLOFENAC SODIUM	DICLOFENAC SODIUM	1%	GEL / TOPICAL			2019-05-16

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
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL	AB	2019-05-16	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A211253-001	DICLOFENAC SODIUM	1%	GEL / TOPICAL		2019-05-16	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2019-12-13 00:20 UTC	2019-12	A211253-001	AB	1	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	A211253-001	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A211253-001	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A211253-001	AB	1	`ea99ee380514…`

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
MOTRIN ARTHRITIS PAIN	DICLOFENAC SODIUM	Kenvue Brands LLC	db5b4288-13ec-826b-e053-2995a90a275e	2024-11-08	Warnings	Exact identifier ndc (package): 50580-574-01 ndc (package): 50580-574-02 ndc (product): 50580-574 ndc11 (package): 50580057402 ndc11 (package): 50580057401 spl id: 21aceda5-2c35-23df-e063-6394a90acb09 spl set id: db5b4288-13ec-826b-e053-2995a90a275e

Reported adverse events (FAERS/openFDA)#

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