Odynia-U

Manufacturer: Ursh Pharmaceutical Inc.
Effective date: 2015-05-14
Label type: HUMAN OTC DRUG LABEL
Version: 7
Source: full-release
Hydrated at: 2026-05-31 22:42:33

Label at a glance#

ProductOdynia-U

Active ingredientLIDOCAINE, CAPSICUM

Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Lidocaine 4 %

Capsicum 0.03 %

OTC - PURPOSE SECTION

Purpose

Topical Analgesic

External Analgesic

INDICATIONS & USAGE SECTION

Uses temporarily relieves minor aches and pains associated with: -arthritis -simple backache --bursitis --tendonitis

--muscle strains --sprains --bruises --cramps

WARNINGS SECTION

Warnings

For external use only

When using this product -use only as directed -do not bandage tightly or use with a heating pad

-avoid contact with eyes and mucus membranes -do not apply to wounds or damaged, broken or irritated skin

OTC - STOP USE SECTION

Stop use and ask a doctor if -condition worsens -redness is present -irritation develops

-symptoms persist for more than 7 days or clear up and occur again within a few days

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask a health professional before use

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

DOSAGE & ADMINISTRATION SECTION

Directions

adults and children over 12 years:

-remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

-carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area

-once exposed portion of patch is positioned, carefully remove remaining backing to completely

apply patch to affected area

-wear one Icy Hot Patch up to 8 hours

-repeat as necessary, but no more than 3 times daily

children under 12 years or younger: ask a doctor

INACTIVE INGREDIENT SECTION

Inactive ingredients aluminum hydroxide, carmellose sodium, glycerin, isopropyl myristate, methyl

acrylate / 2 -ethylhexyl acrylate copolymer, nonoxynol-30, polyacryic acid, polysorbate 80, sodium polyacrylate, sorbitan

sesquioleate, starch / acrylic acid graft copolymer sodium salt, talc, tartaric acid, titanium dioxide, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

copy of label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1605695	Capsicum extract 0.03 % / lidocaine 4 % Medicated Patch	PSN	7
1605695	Capsicum extract 0.0003 MG/MG / lidocaine 0.04 MG/MG Medicated Patch	SCD	7
1605695	Capsicum extract 0.03 % / lidocaine 4 % Medicated Patch	SY	7

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
CAPSICUM Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
69647-003-01	2020-01-31	C162847	48780-1	9d75b9d0-c8ad-f424-e053-dadaa90a57ce	Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
69647-003-01	Odynia-U	15 in 1 BOX	PATCH	15		7
69647-003-01	Odynia-U	10 g in 1 PATCH	PATCH	10		7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
69647-003	ODYNIA-U (LIDOCAINE, CAPSICUM) PATCH [URSH PHARMACEUTICAL INC.]	7	Legacy NDC, 2 package rows	20150517_ee8d953d-ecc4-4013-8227-fa18e6d6d24f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
CAPSICUM	ACTIVE INGREDIENT	00UK7646FG	7
LIDOCAINE	ACTIVE INGREDIENT	98PI200987	7
CAPSICUM	ACTIVE MOIETY	00UK7646FG	7
LIDOCAINE	ACTIVE MOIETY	98PI200987	7
2-ETHYLHEXYL ACRYLATE	INACTIVE INGREDIENT	HR49R9S6XG	7
ACRYLIC ACID	INACTIVE INGREDIENT	J94PBK7X8S	7
ALUMINUM HYDROXIDE	INACTIVE INGREDIENT	5QB0T2IUN0	7
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	INACTIVE INGREDIENT	K679OBS311	7
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	7
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	7
METHYL ACRYLATE	INACTIVE INGREDIENT	WC487PR91H	7
NONOXYNOL-30	INACTIVE INGREDIENT	JJX07DG188	7
POLYACRYLIC ACID (250000 MW)	INACTIVE INGREDIENT	9G2MAD7J6W	7
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	7
SODIUM	INACTIVE INGREDIENT	9NEZ333N27	7
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	7
SODIUM POLYACRYLATE (2500000 MW)	INACTIVE INGREDIENT	05I15JNI2J	7
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	7
TALC	INACTIVE INGREDIENT	7SEV7J4R1U	7
TARTARIC ACID	INACTIVE INGREDIENT	W4888I119H	7
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	7
WATER	INACTIVE INGREDIENT	059QF0KO0R	7

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

Odynia-U
LIDOCAINE, CAPSICUM
LIDOCAINE
CAPSICUM
ALUMINUM HYDROXIDE
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM
GLYCERIN
ISOPROPYL MYRISTATE
METHYL ACRYLATE
2-ETHYLHEXYL ACRYLATE
NONOXYNOL-30
POLYACRYLIC ACID (250000 MW)
POLYSORBATE 80
SODIUM POLYACRYLATE (2500000 MW)
SORBITAN SESQUIOLEATE
ACRYLIC ACID
SODIUM
SODIUM CHLORIDE
TALC
TARTARIC ACID
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
69647-003	69647-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE	98PI200987	ACTIB
CAPSICUM	00UK7646FG	ACTIB
ALUMINUM HYDROXIDE	5QB0T2IUN0	IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	K679OBS311	IACT
GLYCERIN	PDC6A3C0OX	IACT
ISOPROPYL MYRISTATE	0RE8K4LNJS	IACT
METHYL ACRYLATE	WC487PR91H	IACT
2-ETHYLHEXYL ACRYLATE	HR49R9S6XG	IACT
NONOXYNOL-30	JJX07DG188	IACT
POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
SODIUM POLYACRYLATE (2500000 MW)	05I15JNI2J	IACT
SORBITAN SESQUIOLEATE	0W8RRI5W5A	IACT
ACRYLIC ACID	J94PBK7X8S	IACT
SODIUM	9NEZ333N27	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
TALC	7SEV7J4R1U	IACT
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 456 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / AURICULAR (OTIC)	0.05 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	TABLET, COATED / ORAL	10 mg		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / INTRAMUSCULAR	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	INJECTION, SOLUTION / SUBCUTANEOUS		18 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / VAGINAL	0.4 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / NASAL	25 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION, GEL FORMING, EXTENDED RELEASE / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / AURICULAR (OTIC)		18 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SYRUP / ORAL		40 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SUSPENSION / ORAL		1080 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	CAPSULE, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION, CONCENTRATE / ORAL	200 mg/1ml		Exact identifier — unii candidate 75 equally ranked IID candidates
ALUMINUM HYDROXIDE	ALUMINUM HYDROXIDE	5QB0T2IUN0	CREAM / TOPICAL	5 %w/w		Exact identifier — unii candidate 4 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	SOLUTION / ORAL		3480 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRATYMPANIC		2 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	PASTE / DENTAL		249 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / SUBCUTANEOUS		1486 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION / OPHTHALMIC		58 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / ORAL		206 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / EPIDURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM, AUGMENTED / TOPICAL		55 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	DOUCHE / VAGINAL	1 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	AEROSOL, FOAM / VAGINAL	0.2 %w/w		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRAVENOUS	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SHAMPOO / TOPICAL	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PERINEURAL		648 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	SYSTEM / TRANSDERMAL		113 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / SUBCUTANEOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, COATED / ORAL		18 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / VAGINAL	3 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / OPHTHALMIC		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL		20 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, CHEWABLE / ORAL		12 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, CHEWABLE / ORAL		20 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE PARTICLES / ORAL		56 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	INJECTION, SUSPENSION / SOFT TISSUE		15 mg	Exact identifier — unii candidate 44 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS	225 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	ENEMA / RECTAL	0.01 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	GRANULE, FOR SUSPENSION / ORAL	15.63 mg/5ml		Exact identifier — unii candidate 44 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL		42 mg	Exact identifier — unii candidate 40 equally ranked IID candidates
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM	CARBOXYMETHYLCELLULOSE SODIUM	K679OBS311	LOTION / TOPICAL	NA		Exact identifier — unii candidate 44 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
TARTARIC ACID	TARTARIC ACID	W4888I119H	PELLET / ORAL		354 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / TOPICAL	0.18 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
TALC	TALC	7SEV7J4R1U	TABLET, DELAYED RELEASE / ORAL		349 mg	Exact identifier — unii candidate 35 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	CREAM / TOPICAL		65000 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
ISOPROPYL MYRISTATE	ISOPROPYL MYRISTATE	0RE8K4LNJS	OINTMENT / TOPICAL	35 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / RESPIRATORY (INHALATION)	5 %w/w		Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	GEL / TOPICAL	0.06 %w/w		Exact identifier — unii candidate 40 equally ranked IID candidates

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
874fcddd-1ceb-49a1-9487-fe199923f046			ee8d953d-ecc4-4013-8227-fa18e6d6d24f	2015-05-14	Warnings	Exact identifier spl id: 874fcddd-1ceb-49a1-9487-fe199923f046 spl set id: ee8d953d-ecc4-4013-8227-fa18e6d6d24f

Reported adverse events (FAERS/openFDA)#

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