NAFTIN ® NAFTIFINE HCl 1% GEL

Manufacturer: Physicians Total Care, Inc.
Effective date: 2013-03-04
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 2
Source: full-release
Hydrated at: 2026-05-31 20:16:38

Label at a glance#

ProductNaftin

Active ingredientNAFTIFINE HYDROCHLORIDE

Label structure12 sections

Indications and uses

Naftin ® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans Efficacy for this organism in this organ system was studied in fewer than 10 infections. and Epidermophyton floccosum.

Dosage and administration

A sufficient quantity of Naftin ® Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftin ® Gel, 1%, the patient should be re-evaluated.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

DESCRIPTION SECTION

Naftin^® Gel, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftin^® Gel, 1% is for topical use only.

Chemical Name

SPL UNCLASSIFIED SECTION

(E)-N-Cinnamyl-N-methyl-1-naphthalenemethylamine hydrochloride.

Naftifine hydrochloride has an empirical formula of C₂₁H₂₁N•HCl and a molecular weight of 323.86.

Contains

SPL UNCLASSIFIED SECTION

Active Ingredient
Naftifine hydrochloride	1%

Inactive Ingredients
polysorbate 80, carbomer 934P, diisopropanolamine, edetate disodium, alcohol (52%v/v) and purified water.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Naftifine hydrochloride is a synthetic allylamine derivative. The following in vitro data are available, but their clinical significance is unknown. Naftifine hydrochloride has been shown to exhibit fungicidal activity in vitro against a broad spectrum of organisms, including Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Epidermophyton floccosum, Microsporum canis, Microsporum audouini, and Microsporum gypseum; and fungistatic activity against Candida species, including Candida albicans. Naftin^® Gel, 1% has only been shown to be clinically effective against the disease entities listed in the INDICATIONS AND USAGE section.

Although the exact mechanism of action against fungi is not known, naftifine hydrochloride appears to interfere with sterol biosynthesis by inhibiting the enzyme squalene 2, 3-epoxidase. This inhibition of enzyme activity results in decreased amounts of sterols, especially ergosterol, and a corresponding accumulation of squalene in the cells.

Pharmacokinetics

PHARMACOKINETICS SECTION

In vitro and in vivo bioavailability studies have demonstrated that naftifine penetrates the stratum corneum in sufficient concentration to inhibit the growth of dermatophytes.

Following single topical applications of ³H-labeled naftifine gel 1% to the skin of healthy subjects, up to 4.2% of the applied dose was absorbed. Naftifine and/or its metabolites are excreted via the urine and feces with a half-life of approximately two to three days.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Naftin^® Gel, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans¹ and Epidermophyton floccosum.¹

1 Efficacy for this organism in this organ system was studied in fewer than 10 infections.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Naftin^® Gel, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS

WARNINGS SECTION

Naftin^® Gel, 1% is for topical use only and not for ophthalmic use.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Naftin^® Gel, 1% is for external use only. If irritation or sensitivity develops with the use of Naftin^® Gel, 1%, treatment should be discontinued and appropriate therapy instituted. Diagnosis of the disease should be confirmed either by direct microscopic examination of a mounting of infected tissue in a solution of potassium hydroxide or by culture on an appropriate medium.

Information for patients

INFORMATION FOR PATIENTS SECTION

The patient should be told to:

Avoid the use of occlusive dressings or wrappings unless otherwise directed by the physician.
Keep Naftin^® Gel, 1% away from the eyes, nose, mouth and other mucous membranes.

Carcinogenesis, mutagenesis, impairment of fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term studies to evaluate the carcinogenic potential of Naftin^® Gel, 1% have not been performed. In vitro and animal studies have not demonstrated any mutagenic effect or effect on fertility.

Pregnancy

PREGNANCY SECTION

Teratogenic Effects

TERATOGENIC EFFECTS SECTION

Pregnancy Category B

SPL UNCLASSIFIED SECTION

Reproduction studies have been performed in rats and rabbits (via oral administration) at doses 150 times or more than the topical human dose and have revealed no evidence of impaired fertility or harm to the fetus due to naftifine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Nursing mothers

NURSING MOTHERS SECTION

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Naftin^® Gel, 1% is administered to a nursing woman.

Pediatric use

PEDIATRIC USE SECTION

Safety and effectiveness in pediatric patients have not been established.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

During clinical trials with Naftin^® Gel, 1%, the incidence of adverse reactions was as follows: burning/stinging (5.0%), itching (1.0%), erythema (0.5%), rash (0.5%), skin tenderness (0.5%).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

A sufficient quantity of Naftin^® Gel, 1% should be gently massaged into the affected and surrounding skin areas twice a day in the morning and evening. The hands should be washed after application.

If no clinical improvement is seen after four weeks of treatment with Naftin^® Gel, 1%, the patient should be re-evaluated.

HOW SUPPLIED

HOW SUPPLIED SECTION

Naftin^® (naftifine hydrochloride) 1% Gel is supplied in collapsible tubes in the following sizes:

40 gram

NDC 54868-2185-2

STORAGE AND HANDLING SECTION

Note: Store at room temperature.

SPL UNCLASSIFIED SECTION

Manufactured for: Merz Pharmaceuticals, Greensboro, NC 27410

5011343
© 2009 Merz Pharmaceuticals
Rev 2/09 Printed in U.S.A.

Relabeling of "Additional Barcode" by:
Physicians Total Care, Inc.
Tulsa, OK 74146

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NAFTIN^®

NAFTIFINE HCl 1% GEL

Rx Only

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
896106	naftifine HCl 1 % Topical Gel	PSN	2
896108	NAFTIN 1 % Topical Gel	PSN	2
896108	naftifine hydrochloride 0.01 MG/MG Topical Gel [Naftin]	SBD	2
896106	naftifine hydrochloride 0.01 MG/MG Topical Gel	SCD	2
896106	naftifine hydrochloride 1 % Topical Gel	SY	2
896108	Naftin 0.01 MG/MG Topical Gel	SY	2
896108	Naftin 1 % Topical Gel	SY	2

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
NAFTIFINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
8f630d5a-8a28-4ac5-8ede-8b54b7617055	Product name	3	20210512
6aca302d-6492-4ac9-8829-e023cb64c91c	Product name	1	20190627
ba2e3195-29b1-b94a-4345-149632e97b51	Product name	3	20161117
7ac69d99-c06d-0e83-7872-6229bc9878f9	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54868-2185-2	2019-09-24	C162847	48780-1	9350213a-4709-c013-e053-90daa90a1393	NAFTIN ® NAFTIFINE HCl 1% GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54868-2185-2	Naftin	1 in 1 CARTON	GEL	1		2
54868-2185-2	Naftin	40 g in 1 TUBE	GEL	40		2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54868-2185	NAFTIN (NAFTIFINE HYDROCHLORIDE) GEL [PHYSICIANS TOTAL CARE, INC.]	2	2 package rows	20130315_c8c13708-b35c-40bf-a911-12e4cffef2a7.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54868-2185-1	GM - Gram	54868-2185	f6b90bab-cbd4-425b-bf18-9fbfa3d215a7	1	2012-07-24
0259-4770-40	GM - Gram	0259-4770	bfdb2f03-6d25-49a7-8b9b-b576ae5b555e	1	2012-07-24
0259-4770-60	GM - Gram	0259-4770	c379db0d-5ca2-4ace-bdcb-1028772b2b56	1	2012-07-24
0259-4770-90	GM - Gram	0259-4770	cfe1e85b-e20f-4e5b-bdb0-39eeac612874	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAFTIFINE HYDROCHLORIDE	ACTIVE INGREDIENT	25UR9N9041	2
NAFTIFINE	ACTIVE MOIETY	4FB1TON47A	2
CARBOMER 934	INACTIVE INGREDIENT	Z135WT9208	2
DIISOPROPANOLAMINE	INACTIVE INGREDIENT	0W44HYL8T5	2
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	2
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

Naftin
naftifine hydrochloride
NAFTIFINE
POLYSORBATE 80
CARBOMER 934
DIISOPROPANOLAMINE
EDETATE DISODIUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
54868-2185	54868-2185-2
0259-4770

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
Name	UNII	Kind
NAFTIFINE HYDROCHLORIDE	25UR9N9041	ACTIB
POLYSORBATE 80	6OZP39ZG8H	IACT
CARBOMER 934	Z135WT9208	IACT
DIISOPROPANOLAMINE	0W44HYL8T5	IACT
EDETATE DISODIUM	7FLD91C86K	IACT

Source Document#

Source XML

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 3 · 172 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVITREAL	0.02 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION/ DROPS / OPHTHALMIC	0.25 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRA-ARTICULAR	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	GRANULE, FOR SUSPENSION / ORAL		240 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, EFFERVESCENT / ORAL		32 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION/ DROPS / ORAL		23 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SPRAY / NASAL	0.01 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, ORALLY DISINTEGRATING / ORAL		1 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	AEROSOL, FOAM / TOPICAL	0.98 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION / ORAL		30 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRALESIONAL	0.05 %w/v		Exact identifier — unii candidate 77 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	INJECTION, SOLUTION / INTRAVENOUS		1170 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, CHEWABLE / ORAL		84 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, COATED / ORAL	0.21 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		900 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / ORAL	0.5 mg/1ml		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / SOFT TISSUE		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LIQUID / INTRAVENOUS		720 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / INTRAVENOUS	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION, EXTENDED RELEASE / ORAL		40 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / VAGINAL	28 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SPRAY, METERED / NASAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM / TOPICAL		14 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CAPSULE, COATED / ORAL	0.04 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SOFT TISSUE		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SOLUTION / INTRAMUSCULAR	5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	ENEMA / RECTAL	0.24 %w/v		Exact identifier — unii candidate 14 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / ORAL		907 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, ORALLY DISINTEGRATING / ORAL		3 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	POWDER, FOR SUSPENSION / ORAL		396 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	LOTION / TOPICAL	15 %w/w		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / OPHTHALMIC		1 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / RECTAL		315 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRALESIONAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / INTRAVENOUS	0.5 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRA-ARTICULAR		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LIQUID / INTRAVENOUS	0.03 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	OINTMENT / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, DELAYED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	TABLET, EXTENDED RELEASE / ORAL		90 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUPPOSITORY / RECTAL	72.15 mg		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	LOTION / TOPICAL		22 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAVENOUS		7 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION / INTRAVENOUS		4680 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
DIISOPROPANOLAMINE	DIISOPROPANOLAMINE	0W44HYL8T5	GEL / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 3 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	SOLUTION / OPHTHALMIC		8 mg	Exact identifier — unii candidate 78 equally ranked IID candidates
CARBOMER 934	CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)	Z135WT9208	SOLUTION / TOPICAL		10 mg	Exact identifier — unii candidate 14 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CONCENTRATE / ORAL		20 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	POWDER, FOR SUSPENSION / ORAL		285 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	INJECTION, SUSPENSION / SUBCUTANEOUS	0.3 %w/v		Exact identifier — unii candidate 78 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	TABLET, FILM COATED / ORAL	24 mg		Exact identifier — unii candidate 78 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
f96d2943-9a0e-47b5-8c05-3d61ded6b051			c8c13708-b35c-40bf-a911-12e4cffef2a7	2013-03-04	Warnings, Adverse reactions	Exact identifier spl id: f96d2943-9a0e-47b5-8c05-3d61ded6b051 spl set id: c8c13708-b35c-40bf-a911-12e4cffef2a7

Reported adverse events (FAERS/openFDA)#

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