Naftifine Hydrochloride 1% Cream

Manufacturer: Renaissance Pharma, Inc.
Effective date: 2015-05-28
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 00:23:26

Label at a glance#

ProductNaftifine Hydrochloride

Active ingredientNAFTIFINE HYDROCHLORIDE

Label structure12 sections

Indications and uses

Naftifine Hydrochloride Cream, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

Dosage and administration

A sufficient quantity of Naftifine Hydrochloride Cream, 1% should be gently massaged into the affected and surrounding skin areas once a day. The hands should be washed after application. If no clinical improvement is seen after four weeks of treatment with Naftifine Hydrochloride Cream, 1%, the patient should be re-evaluated.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Rx Only

DESCRIPTION

DESCRIPTION SECTION

Naftifine Hydrochloride Cream, 1% contains the synthetic, broad-spectrum, antifungal agent naftifine hydrochloride. Naftifine Hydrochloride Cream, 1% is for topical use only.

SPL UNCLASSIFIED SECTION

Chemical Name

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

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

SPL UNCLASSIFIED SECTION

Active Ingredient: Naftifine hydrochloride 1%

Inactive Ingredients: benzyl alcohol, cetyl alcohol, cetyl esters wax, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, and stearyl alcohol. Hydrochloric acid may be added to adjust pH.

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. Naftifine Hydrochloride Cream, 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 a single topical application of 1% naftifine cream to the skin of healthy subjects, systemic absorption of naftifine was approximately 6% of the applied dose. 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

Naftifine Hydrochloride Cream, 1% is indicated for the topical treatment of tinea pedis, tinea cruris and tinea corporis caused by the organisms Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Naftifine Hydrochloride Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its components.

WARNINGS

WARNINGS SECTION

Naftifine Hydrochloride Cream, 1% is for topical use only and not for ophthalmic use.

PRECAUTIONS

PRECAUTIONS SECTION

General

GENERAL PRECAUTIONS SECTION

Naftifine Hydrochloride Cream, 1% is for external use only. If irritation or sensitivity develops with the use of Naftifine Hydrochloride Cream, 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 Naftifine Hydrochloride Cream, 1% away from the eyes, nose, mouth and other mucous membranes.

Carcinogenesis, mutagenesis, impairment of fertility

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY SECTION

Long-term animal studies to evaluate the carcinogenic potential of Naftifine Hydrochloride Cream, 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 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 Naftifine Hydrochloride Cream, 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 Naftifine Hydrochloride Cream, 1%, the incidence of adverse reactions was as follows: burning/stinging (6%), dryness (3%), erythema (2%), itching (2%), local irritation (2%).

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

HOW SUPPLIED

HOW SUPPLIED SECTION

Naftifine Hydrochloride 1% Cream is supplied in the following sizes:

30g—NDC 40085-201-30 (tube)
60g—NDC 40085-201-60 (tube)
90g—NDC 40085-201-90 (tube)

STORAGE AND HANDLING SECTION

Tubes: Store below 30° (86°F).

SPL UNCLASSIFIED SECTION

Manufactured for: Renaissance Pharma, Inc. Newtown, PA 18940
Manufactured by: DPT Laboratories, Ltd., San Antonio, TX 78215
140364
Printed in U.S.A.
Iss. 10/2014

PRINCIPAL DISPLAY PANEL - 90 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 40085-201-90

Naftifine HCl 1% Cream

For Topical Use Only
Not for Ophthalmic Use

Renaissance
Pharma

90 g Cream

Rx Only

PRINCIPAL DISPLAY PANEL - 90 g Tube Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
40085-201-60	GM - Gram	40085-201	8bc3e124-ddff-470d-9589-d4b323caffaf	1	2015-07-20
40085-201-90	GM - Gram	40085-201	e692c6e4-45f2-4ff9-bba0-5d490606d5e1	1	2015-07-20

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
NAFTIFINE HYDROCHLORIDE	ACTIVE INGREDIENT	25UR9N9041	1
NAFTIFINE	ACTIVE MOIETY	4FB1TON47A	1
Benzyl Alcohol	INACTIVE INGREDIENT	LKG8494WBH	1
Cetyl Alcohol	INACTIVE INGREDIENT	936JST6JCN	1
Cetyl Esters Wax	INACTIVE INGREDIENT	D072FFP9GU	1
Isopropyl Myristate	INACTIVE INGREDIENT	0RE8K4LNJS	1
Polysorbate 60	INACTIVE INGREDIENT	CAL22UVI4M	1
Sorbitan Monostearate	INACTIVE INGREDIENT	NVZ4I0H58X	1
Stearyl Alcohol	INACTIVE INGREDIENT	2KR89I4H1Y	1
Water	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Naftifine Hydrochloride
NAFTIFINE
Water
Isopropyl Myristate
Polysorbate 60
Stearyl Alcohol
Cetyl Alcohol
Cetyl Esters Wax
Sorbitan Monostearate
Benzyl Alcohol

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
40085-201	40085-201-60, 40085-201-90

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
NAFTIFINE HYDROCHLORIDE	25UR9N9041	ACTIB
Water	059QF0KO0R	IACT
Isopropyl Myristate	0RE8K4LNJS	IACT
Polysorbate 60	CAL22UVI4M	IACT
Stearyl Alcohol	2KR89I4H1Y	IACT
Cetyl Alcohol	936JST6JCN	IACT
Cetyl Esters Wax	D072FFP9GU	IACT
Sorbitan Monostearate	NVZ4I0H58X	IACT
Benzyl Alcohol	LKG8494WBH	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 · 129 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	POWDER, FOR SUSPENSION / ORAL	NA		Exact identifier — unii candidate 5 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / SUBCUTANEOUS	0.95 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	TABLET, FILM COATED, EXTENDED RELEASE / ORAL		120 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	CREAM / VAGINAL		200 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	LOTION / TOPICAL		89 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	OINTMENT / TOPICAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 12 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRAVENOUS		400 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SHAMPOO / TOPICAL	14.55 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 12 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / VAGINAL	0.03 mg		Exact identifier — unii candidate 13 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUPPOSITORY / RECTAL	129 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SOLUTION / INTRAMUSCULAR		54 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Stearyl Alcohol	STEARYL ALCOHOL	2KR89I4H1Y	POWDER / ORAL	0.11 mg		Exact identifier — unii candidate 12 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRAVENOUS		1620 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / SOFT TISSUE		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	OINTMENT / TOPICAL	2 %w/w		Exact identifier — unii candidate 13 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / AURICULAR (OTIC)	1 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	SUSPENSION / AURICULAR (OTIC)	0.02 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SUSPENSION / ORAL		125 mg	Exact identifier — unii candidate 13 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	144 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / TOPICAL	2.15 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SHAMPOO / TOPICAL	1.25 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	AEROSOL, FOAM / TOPICAL	0.55 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL, FOAM / VAGINAL	0.75 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	GEL / RECTAL		124 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SUSPENSION / TOPICAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SOLUTION / INTRA-ARTICULAR		23 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	TABLET / ORAL	1.06 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	SPRAY, METERED / NASAL	5 mg/1ml		Exact identifier — unii candidate 50 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	OINTMENT / TOPICAL	7 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	SUPPOSITORY / RECTAL	0.05 mg/mg		Exact identifier — unii candidate 13 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL / TOPICAL	9.3 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	LOTION / TOPICAL		50 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SPRAY / TOPICAL	4.58 %w/w		Exact identifier — unii candidate 11 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	GEL / TOPICAL		29 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / OPHTHALMIC	0.5 %w/v		Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CREAM / VAGINAL	1 %w/w		Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / SUBCONJUNCTIVAL		252 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	LIQUID / INTRAVENOUS	1.04 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, FOAM / TOPICAL		144 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Esters Wax	CETYL ESTERS WAX	D072FFP9GU	CREAM / TOPICAL	10.3 %w/w		Exact identifier — unii candidate 5 equally ranked IID candidates
Isopropyl Myristate	ISOPROPYL MYRISTATE	0RE8K4LNJS	AEROSOL, SPRAY / TOPICAL	6.89 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	CAPSULE, DELAYED RELEASE / ORAL		59 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION / INTRA-ARTICULAR	1 %w/v		Exact identifier — unii candidate 50 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / VAGINAL		100 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	LOTION / TOPICAL		1140 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED / ORAL	NA		Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS		18 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Cetyl Alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, ORALLY DISINTEGRATING / ORAL		9 mg	Exact identifier — unii candidate 20 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, SUSPENSION / INTRAMUSCULAR		40 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	CREAM / TOPICAL		177 mg	Exact identifier — unii candidate 11 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	INJECTION, EMULSION / INTRAMUSCULAR		225 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CAPSULE / ORAL		450 mg	Exact identifier — unii candidate 50 equally ranked IID candidates
Benzyl Alcohol	BENZYL ALCOHOL	LKG8494WBH	CAPSULE, EXTENDED RELEASE / ORAL	1.23 mg		Exact identifier — unii candidate 50 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUSPENSION / ORAL	62.5 mg/5ml		Exact identifier — unii candidate 11 equally ranked IID candidates
Polysorbate 60	POLYSORBATE 60	CAL22UVI4M	TABLET, COATED / ORAL	NA		Exact identifier — unii candidate 13 equally ranked IID candidates
Sorbitan Monostearate	SORBITAN MONOSTEARATE	NVZ4I0H58X	SUPPOSITORY / VAGINAL	NA		Exact identifier — unii candidate 11 equally ranked IID candidates

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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
N019599-001	NAFTIN	NAFTIFINE HYDROCHLORIDE	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29
N019599-002	NAFTIN	NAFTIFINE HYDROCHLORIDE	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019599-002	AB

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 3 · 86 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	RLD / RS	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019599-001	NAFTIN	1% Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons	CREAM / TOPICAL		RLD	1988-02-29	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019599-001	NAFTIN	1%	CREAM / TOPICAL		RLD	1988-02-29	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019599-001	NAFTIN	1%	CREAM / TOPICAL		RLD	1988-02-29	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019599-001	NAFTIN	1%	CREAM / TOPICAL		RLD	1988-02-29	`74a2ff9319b5…`
2019-12-13 00:20 UTC	2019-12	N019599-002	NAFTIN	2%	CREAM / TOPICAL	AB	RLD, RS	2012-01-13	`74a2ff9319b5…`

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N019599-002	AB	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N019599-002	AB	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N019599-002	AB	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N019599-002	AB	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N019599-002	AB	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N019599-002	AB	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N019599-002	AB	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N019599-002	AB	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N019599-002	AB	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N019599-002	AB	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N019599-002	AB	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N019599-002	AB	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N019599-002	AB	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N019599-002	AB	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N019599-002	AB	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N019599-002	AB	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N019599-002	AB	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N019599-002	AB	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N019599-002	AB	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N019599-002	AB	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N019599-002	AB	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N019599-002	AB	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N019599-002	AB	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N019599-002	AB	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N019599-002	AB	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N019599-002	AB	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N019599-002	AB	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019599-002	AB	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019599-002	AB	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N019599-002	AB	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N019599-002	AB	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N019599-002	AB	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N019599-002	AB	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N019599-002	AB	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N019599-002	AB	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N019599-002	AB	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N019599-002	AB	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N019599-002	AB	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N019599-002	AB	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N019599-002	AB	1	`f41ea6bd6efb…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2019-12-13 00:20 UTC	2019-12	N019599-002	M-191	2019-11-10	`74a2ff9319b5…`
2019-12-14 00:12 UTC	2019-12	N019599-002	M-191	2019-11-10	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N019599-002	M-191	2019-11-10	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N019599-002	M-191	2019-11-10	`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
00484c06-4cd0-4788-a4ce-1e21e50d6ae3			ee46c902-8a59-40f7-ac99-e96a8b981d60	2015-05-28	Warnings, Adverse reactions	Exact identifier spl id: 00484c06-4cd0-4788-a4ce-1e21e50d6ae3 spl set id: ee46c902-8a59-40f7-ac99-e96a8b981d60

Reported adverse events (FAERS/openFDA)#

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