TERAZOL ® 7 (terconazole) Vaginal Cream 0.4%, TERAZOL ® 3 (terconazole) Vaginal Cream 0.8% and TERAZOL ® 3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
One full applicator (5 g) of TERAZOL ® 7 Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days. One full applicator (5 g) of TERAZOL ® 3 Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days. One TERAZOL ® 3 Vaginal Suppository (80 mg terconazole) should be administered intravaginal...
TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is a white to off-white, water washable cream for intravaginal administration containing 0.4% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.
TERAZOL® 3 (terconazole) Vaginal Cream 0.8% is a white to off-white, water washable cream for intravaginal administration containing 0.8% of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, compounded in a cream base consisting of butylated hydroxyanisole, cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl alcohol, and purified water.
TERAZOL® 3 (terconazole) Vaginal Suppositories are white to off-white suppositories for intravaginal administration containing 80 mg of the antifungal agent terconazole, cis-1-[p-[[2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]-4-isopropylpiperazine, in triglycerides derived from coconut and/or palm kernel oil (a base of hydrogenated vegetable oils) and butylated hydroxyanisole.
The structural formula of terconazole is as follows:
Terconazole, a triazole derivative, is a white to almost white powder with a molecular weight of 532.47. It is insoluble in water; sparingly soluble in ethanol; and soluble in butanol.
Following a single intravaginal application of a suppository containing 240 mg 14C-terconazole to healthy women, approximately 70% (range: 64–76%) of terconazole remains in the vaginal area during the suppository retention period (16 hours); approximately 10% (range: 5–16%) of the administered radioactivity was absorbed systemically over 7 days. Maximum plasma concentrations of terconazole occur 5 to 10 hours after intravaginal application of the cream or suppository. Systemic exposure to terconazole is approximately proportional to the applied dose, whether as the cream or suppository. The rate and extent of absorption of terconazole are similar in patients with vulvovaginal candidiasis (pregnant or non-pregnant) and healthy subjects.
Terconazole is highly protein bound (94.9%) in human plasma and the degree of binding is independent of drug concentration over the range of 0.01 to 5.0 mcg/mL.
Systemically absorbed terconazole is extensively metabolized (>95%).
Across various studies in healthy women, after single or multiple intravaginal administration of terconazole as the cream or suppository/ovule, the mean elimination half-life of unchanged terconazole ranged from 6.4 to 8.5 hours. Following a single intravaginal administration of a suppository containing 240 mg 14C-terconazole to hysterectomized or tubal ligated women, approximately 3 to 10% (mean ± SD: 5.7 ± 3.0%) of the administered radioactivity was eliminated in the urine and 2 to 6% (mean ± SD: 4.2 ± 1.6%) was eliminated in the feces during the 7-day collection period.
There is no significant increase in maximum plasma concentration or overall exposure (AUC) after multiple daily applications of the cream for 7 days or suppositories for 3 days.
Photosensitivity reactions were observed in some normal volunteers following repeated dermal application of terconazole 2.0% and 0.8% creams under conditions of filtered artificial ultraviolet light.
Photosensitivity reactions have not been observed in U.S. and foreign clinical trials in patients who were treated with terconazole suppositories or vaginal cream (0.4% and 0.8%).
Terconazole, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha-lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the antifungal activity of terconazole. Mammalian cell demethylation is less sensitive to terconazole inhibition.
Terconazole exhibits antifungal activity in vitro against Candida albicans and other Candida species. The MIC values of terconazole against most Lactobacillus spp. typically found in the human vagina were ≥128 mcg/mL; therefore these beneficial bacteria are not affected by drug treatment.
TERAZOL® 7 (terconazole) Vaginal Cream 0.4%, TERAZOL® 3 (terconazole) Vaginal Cream 0.8% and TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg are indicated for the local treatment of vulvovaginal candidiasis (moniliasis). As these products are effective only for vulvovaginitis caused by the genus Candida, the diagnosis should be confirmed by KOH smears and/or cultures.
Patients known to be hypersensitive to terconazole or to any of the components of the cream or suppositories.
Anaphylaxis and toxic epidermal necrolysis have been reported during terconazole therapy. TERAZOL® therapy should be discontinued if anaphylaxis or toxic epidermal necrolysis develops.
For vulvovaginal use only. TERAZOL® is not for ophthalmic or oral use. Discontinue use and do not retreat with terconazole if sensitization, irritation, fever, chills or flu-like symptoms are reported during use.
The base contained in the suppository formulation may interact with certain rubber or latex products, such as those used in vaginal contraceptive diaphragms or latex condoms; therefore concurrent use is not recommended.
If there is lack of response to terconazole, appropriate microbiologic studies (standard KOH smear and/or cultures) should be repeated to confirm the diagnosis and rule out other pathogens.
The therapeutic effect of terconazole is not affected by oral contraceptive usage.
The levels of estradiol and progesterone did not differ significantly when 0.8% terconazole vaginal cream was administered to healthy female volunteers established on a low dose oral contraceptive.
Studies to determine the carcinogenic potential of terconazole have not been performed.
Terconazole was not mutagenic when tested in vitro for induction of microbial point mutations (Ames test), or for inducing cellular transformation, or in vivo for chromosome breaks (micronucleus test) or dominant lethal mutations in mouse germ cells.
No impairment of fertility occurred when female rats were administered terconazole orally up to 40 mg/kg/day for a three month period.
There was no evidence of teratogenicity when terconazole was administered orally up to 40 mg/kg/day (25× the recommended intravaginal human dose of the suppository formulation, 50× the recommended intravaginal human dose of the 0.8% vaginal cream formulation, and 100× the intravaginal human dose of the 0.4% vaginal cream formulation) in rats, or 20 mg/kg/day in rabbits, or subcutaneously up to 20 mg/kg/day in rats.
Dosages at or below 10 mg/kg/day produced no embryotoxicity; however, there was a delay in fetal ossification at 10 mg/kg/day in rats. There was some evidence of embryotoxicity in rabbits and rats at 20–40 mg/kg. In rats, this was reflected as a decrease in litter size and number of viable young and reduced fetal weight. There was also delay in ossification and an increased incidence of skeletal variants.
The no-effect dose of 10 mg/kg/day resulted in a mean peak plasma level of terconazole in pregnant rats of 0.176 mcg/mL which exceeds by 44 times the mean peak plasma level (0.004 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.4% vaginal cream, by 30 times the mean peak plasma level (0.006 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 0.8% vaginal cream, and by 17 times the mean peak plasma level (0.010 mcg/mL) seen in normal subjects after intravaginal administration of terconazole 80 mg vaginal suppository. This safety assessment does not account for possible exposure of the fetus through direct transfer to terconazole from the irritated vagina by diffusion across amniotic membranes.
Since terconazole is absorbed from the human vagina, it should not be used in the first trimester of pregnancy unless the physician considers it essential to the welfare of the patient.
Terconazole may be used during the second and third trimester if the potential benefit outweighs the possible risks to the fetus.
It is not known whether this drug is excreted in human milk. Animal studies have shown that rat offspring exposed via the milk of treated (40 mg/kg/orally) dams showed decreased survival during the first few post-partum days, but overall pup weight and weight gain were comparable to or greater than controls throughout lactation. Because many drugs are excreted in human milk, and because of the potential for adverse reaction in nursing infants from terconazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
Safety and efficacy in children have not been established.
Clinical studies of TERAZOL® did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients.
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.
During controlled clinical studies conducted in the United States, 521 patients with vulvovaginal candidiasis were treated with terconazole 0.4% vaginal cream. Based on comparative analyses with placebo, the adverse experiences considered most likely related to terconazole 0.4% vaginal cream were headache (26% vs. 17% with placebo) and body pain (2.1% vs. 0% with placebo). Fever (1.7% vs. 0.5% with placebo) and chills (0.4% vs. 0.0% with placebo), vulvovaginal burning, itching and irritation have also been reported. The adverse drug experience on terconazole most frequently causing discontinuation was vulvovaginal itching.
During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole 0.8% vaginal cream for three days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole 0.8% vaginal cream were headache (21% vs. 16% with placebo) and dysmenorrhea (6% vs. 2% with placebo). Other adverse experiences reported with terconazole 0.8% vaginal cream were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole 0.8% vaginal cream group and 0.3% with the placebo group.
During controlled clinical studies conducted in the United States, 284 patients with vulvovaginal candidiasis were treated with terconazole 80 mg vaginal suppositories. Based on comparative analyses with placebo (295 patients), the adverse experiences considered adverse reactions most likely related to terconazole 80 mg vaginal suppositories were headache (30.3% vs. 20.7% with placebo) and pain of the female genitalia (4.2% vs. 0.7% with placebo). Adverse reactions that have also been reported but were not statistically significantly different from placebo were burning (15.2% vs. 11.2% with placebo) and body pain (3.9% vs. 1.7% with placebo). Fever (2.8% vs. 1.4% with placebo) and chills (1.8% vs. 0.7% with placebo) have also been reported. The adverse drug experience on terconazole most frequently causing discontinuation was burning (2.5% vs. 1.4% with placebo) and pruritus (1.8% vs. 1.4% with placebo).
The following adverse drug reactions have been first identified during post-marketing experience with TERAZOL®. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
General: Asthenia, Influenza-Like Illness consisting of multiple listed reactions including fever and chills, nausea, vomiting, myalgia, arthralgia, malaise
Immune: Hypersensitivity, Anaphylaxis, Face Edema
Nervous: Dizziness
Respiratory: Bronchospasm
Skin: Rash, Toxic Epidermal Necrolysis, Urticaria
In the rat, the oral LD 50 values were found to be 1741 and 849 mg/kg for the male and female, respectively. The oral LD 50 values for the male and female dog were ≅1280 and ≥640 mg/kg, respectively.
In the event of oral ingestion of suppository or cream, supportive and symptomatic measures should be carried out. If the cream is accidentally applied to the eyes, wash with clean water or saline and seek medical attention if symptoms persist.
One full applicator (5 g) of TERAZOL® 7 Vaginal Cream (20 mg terconazole) should be administered intravaginally once daily at bedtime for seven consecutive days.
One full applicator (5 g) of TERAZOL® 3 Vaginal Cream (40 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.
One TERAZOL® 3 Vaginal Suppository (80 mg terconazole) should be administered intravaginally once daily at bedtime for three consecutive days.
Before prescribing another course of therapy, the diagnosis should be reconfirmed by smears and/or cultures and other pathogens commonly associated with vulvovaginitis ruled out. The therapeutic effect of these products is not affected by menstruation.
TERAZOL® 7 (terconazole) Vaginal Cream 0.4% is available in 45 g (NDC 50458-535-01) tubes with an ORTHO1 Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).
TERAZOL® 3 (terconazole) Vaginal Cream 0.8% is available in 20 g (NDC 50458-536-01) tubes with an ORTHO1 Measured-Dose Applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).
TERAZOL® 3 (terconazole) Vaginal Suppositories 80 mg are available as 2.5 g, elliptically-shaped white to off-white suppositories in packages of three (NDC 50458-531-01) with a vaginal applicator. Store at Controlled Room Temperature 15–30°C (59–86°F).
1 Trademark
Manufactured by:
Janssen Ortho, LLC, Manati, Puerto Rico 00674 (for the Vaginal Cream)
Jubilant HollisterStier General Partnership, Kirkland, Quebec, Canada H9H 4J4 (for the Vaginal Cream and Vaginal Suppositories)
Manufactured for:
(logo)
Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560
© Janssen Pharmaceuticals, Inc. 1998
Revised May 2018
TERAZOL® 7 VAGINAL CREAM 0.4%
(terconazole)
TERAZOL® 3 VAGINAL CREAM 0.8%
(terconazole)
PATIENT INSTRUCTIONS
Filling the applicator:
Using the applicator:
Cleaning the applicator: (Does not apply to sample applicators, which are for one time use only)
After each use, you should thoroughly clean the applicator by following the procedure below:
NOTE: Store the cream at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.
TERAZOL® 3 VAGINAL SUPPOSITORIES 80 mg
(terconazole)
Three oval suppositories, for use inside the vagina only.
Designed to be inserted into the vagina.
HOW TO USE:
Place one suppository into the vagina each night at bedtime, for 3 nights, as directed by your doctor. The TERAZOL® Suppository is self-lubricating and may be inserted with or without the applicator.
After each use, you should thoroughly clean the applicator by following the procedure below:
NOTE: Store the suppositories at Controlled Room Temperature 15–30°C (59–86°F). See end flap for lot number and expiration date.
A WORD ABOUT YEAST INFECTIONS
Why do yeast infections occur?
Yeast infections are caused by an organism called Candida (KAN di duh). It may be present in small and harmless amounts in the mouth, digestive tract, and vagina. Sometimes the natural balance of the vagina becomes upset. This may lead to rapid growth of Candida, which results in a yeast infection. Symptoms of a yeast infection include itching, burning, redness, and an abnormal discharge.
Your doctor can make the diagnosis of a yeast infection by evaluating your symptoms and looking at a sample of the discharge under the microscope.
How can I prevent yeast infections?
Certain factors may increase your chance of developing a yeast infection. These factors don't actually cause the problem, but they may create a situation that allows the yeast to grow rapidly.
Controlling these factors can help eliminate yeast infections and may prevent them from coming back.
Some other helpful tips:
Manufactured by:
Manufactured for:
(logo)
Janssen Pharmaceuticals, Inc. Titusville, New Jersey 08560
© Janssen Pharmaceuticals, Inc. 1998
Revised July 2014
NDC 50458-535-01
TERAZOL® 7
(terconazole)
VAGINAL CREAM 0.4%
Tube and Applicator
Compounded with: Butylated hydroxyanisole, cetyl alcohol, isopropyl
myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl
alcohol and purified water.
Rx only.
Prescribing information enclosed. Store at controlled room temperature
15-30°C (59-86°F). See end panel for lot number and expiration date.
Keep out of reach of children.
Net weight 1.59 oz. (45g)
Manufactured by:
Janssen Ortho, LLC
Manati, Puerto Rico 00674
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
janssen
NDC 50458-536-01
TERAZOL® 3
(terconazole)
VAGINAL CREAM 0.8%
Tube and Applicator
Compounded with: Butylated hydroxyanisole, cetyl alcohol, isopropyl
myristate, polysorbate 60, polysorbate 80, propylene glycol, stearyl
alcohol and purified water.
Rx only.
Prescribing information enclosed. Store at controlled room temperature
15-30°C (59-86°F). See end panel for lot number and expiration date.
Keep out of reach of children.
Net weight 0.71 oz. (20g)
Manufactured by:
Janssen Ortho, LLC
Manati, Puerto Rico 00674
Manufactured for:
Janssen Pharmaceuticals, Inc.
Titusville, NJ 08560
janssen
TERAZOL® 3
(terconazole)
VAGINAL SUPPOSITORIES 80mg
With Applicator
NDC 0062-5351-01
Each suppository contains terconazole 80 mg compounded with
triglycerides derived from coconut and/or palm kernel oil (a base
of hydrogenated vegetable oils) and butylated hydroxyanisole.
Rx only.
Prescribing information enclosed.
Store at 15-30°C (59-86°F).
See end panel for lot number and expiration date.
Keep out of reach of children.
3 suppositories with vaginal applicator.
Manufactured by:
DRAXIS Specialty Pharmaceuticals Inc.
Kirkland, Quebec, Canada
H9H 4J4
ORTHO WOMEN'S HEALTH & UROLOGY™
DIVISION OF ORTHO-MCNEIL-JANSSEN PHARMACEUTICALS, INC.
Manufactured for:
Ortho Women's Health & Urology,
Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc.
Raritan, New Jersey 08869
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 50458-535-01 | GM - Gram | 50458-535 | 4ad4a221-44d8-4a42-8e58-ec5aa7de5d1c | 1 | 2014-09-03 |
| 50458-536-01 | GM - Gram | 50458-536 | 4133c361-797e-4680-9df3-b8f81774ee1b | 1 | 2014-09-03 |
| 50458-531-01 | EA - Each | 50458-531 | 44994bc7-a73a-430e-948d-2055ff725405 | 1 | 2014-09-03 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| TERCONAZOLE | ACTIVE INGREDIENT | 0KJ2VE664U | 4 | |
| TERCONAZOLE | ACTIVE MOIETY | 0KJ2VE664U | 4 | |
| BUTYLATED HYDROXYANISOLE | INACTIVE INGREDIENT | REK4960K2U | 4 | |
| CETYL ALCOHOL | INACTIVE INGREDIENT | 936JST6JCN | 4 | |
| COCONUT OIL | INACTIVE INGREDIENT | Q9L0O73W7L | 4 | |
| ISOPROPYL MYRISTATE | INACTIVE INGREDIENT | 0RE8K4LNJS | 4 | |
| PALM KERNEL OIL | INACTIVE INGREDIENT | B0S90M0233 | 4 | |
| POLYSORBATE 60 | INACTIVE INGREDIENT | CAL22UVI4M | 4 | |
| POLYSORBATE 80 | INACTIVE INGREDIENT | 6OZP39ZG8H | 4 | |
| PROPYLENE GLYCOL | INACTIVE INGREDIENT | 6DC9Q167V3 | 4 | |
| STEARYL ALCOHOL | INACTIVE INGREDIENT | 2KR89I4H1Y | 4 | |
| WATER | INACTIVE INGREDIENT | 059QF0KO0R | 4 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 50458-535 | 50458-535-01 |
| 50458-536 | 50458-536-01 |
| 50458-531 | 50458-531-01 |
Every source-derived ingredient row is available through these pages.
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.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | GEL, METERED / TRANSDERMAL | 50 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED / ORAL | 96 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUSPENSION / ORAL | 125 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION / INTRALESIONAL | 4 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | SUPPOSITORY / RECTAL | 0.05 mg/mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | SUSPENSION / TOPICAL | 2.01 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRALESIONAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | POWDER, FOR SUSPENSION / ORAL | 396 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | CAPSULE, DELAYED RELEASE / ORAL | 23 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, POWDER, FOR SUSPENSION / INTRA-ARTICULAR | 5 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | CAPSULE, EXTENDED RELEASE / ORAL | 72 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION/ DROPS / AURICULAR (OTIC) | 13 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SOLUTION / INTRAVENOUS | 900 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | OINTMENT / VAGINAL | 0.02 %w/w | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET, EXTENDED RELEASE / ORAL | 1 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | LOTION / TOPICAL | 1140 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRA-ARTICULAR | 4 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, METERED / RECTAL | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / VAGINAL | 1225 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | DROPS / ORAL | 200 mg/1ml | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SYSTEM / TOPICAL | 28 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | FILM, SOLUBLE / BUCCAL | 5 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | DROPS / AURICULAR (OTIC) | 0.02 %w/w | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | CREAM / VAGINAL | 200 mg | ||
| STEARYL ALCOHOL | STEARYL ALCOHOL | 2KR89I4H1Y | TABLET, EXTENDED RELEASE / ORAL | 244 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | AEROSOL, FOAM / VAGINAL | 3 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CREAM / TOPICAL | 76000 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION / OPHTHALMIC | 1 %w/v | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | EMULSION / TOPICAL | NA | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL | 34 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SPRAY, METERED / NASAL | 0.1 mg/1ml | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | CREAM / VAGINAL | 0.03 %w/w | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / SUBCUTANEOUS | 0.3 %w/v | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | OINTMENT / TOPICAL | 14.75 %w/w | ||
| ISOPROPYL MYRISTATE | ISOPROPYL MYRISTATE | 0RE8K4LNJS | CREAM / TOPICAL | 65000 mg | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | AEROSOL, FOAM / TOPICAL | 30 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | EMULSION / TOPICAL | 8 %w/w | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY, METERED / NASAL | 240 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SYRUP / ORAL | 5700 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | INJECTION, SOLUTION / INTRAVENOUS | NA | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | CLOTH / TOPICAL | 0.03 mg/mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | INJECTION, SOLUTION / INTRAMUSCULAR | 4000 mg | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | TABLET / ORAL | 8 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | SUSPENSION / RESPIRATORY (INHALATION) | 1 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | TABLET, DELAYED RELEASE / ORAL | 4 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | INJECTION, SUSPENSION / INTRAVENOUS | 0.5 %w/v | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SPRAY / NASAL | 5 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | OINTMENT / RECTAL | 27 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET, FILM COATED, EXTENDED RELEASE / ORAL | 19 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | SOLUTION/ DROPS / AURICULAR (OTIC) | ADJ PH | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, COATED / ORAL | 0.25 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | AEROSOL, FOAM / RECTAL | 1214 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | SUSPENSION / AURICULAR (OTIC) | 1 %w/v | ||
| POLYSORBATE 60 | POLYSORBATE 60 | CAL22UVI4M | CREAM / TOPICAL | 225 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | AEROSOL, FOAM / TOPICAL | 82 mg | ||
| POLYSORBATE 80 | POLYSORBATE 80 | 6OZP39ZG8H | EMULSION / TOPICAL | 34050 mg | ||
| CETYL ALCOHOL | CETYL ALCOHOL | 936JST6JCN | TABLET, FILM COATED / ORAL | NA | ||
| BUTYLATED HYDROXYANISOLE | BUTYLATED HYDROXYANISOLE | REK4960K2U | GEL / TOPICAL | 7 mg | ||
| PROPYLENE GLYCOL | PROPYLENE GLYCOL | 6DC9Q167V3 | TABLET / ORAL | 64 mg | ||
| COCONUT OIL | COCONUT OIL | Q9L0O73W7L | TABLET / ORAL | NA |
All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019579-001 | TERAZOL 7 | TERCONAZOLE | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019579-001 | TERAZOL 7 | 0.4% | CREAM / VAGINAL | RLD | 1987-12-31 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019579-001 | TERAZOL 7 | 0.4% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1987-12-31 | 3a93d1ddd44b… |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019641-001 | TERAZOL 3 | TERCONAZOLE | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019641-001 | TERAZOL 3 | 80MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019641-001 | TERAZOL 3 | 80MG | SUPPOSITORY / VAGINAL | RLD | 1988-05-24 | 3a93d1ddd44b… |
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019964-001 | TERAZOL 3 | TERCONAZOLE | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-10-15 13:18:30 | 2026-09 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | c2088c7a36db… | |
| 2026-09-14 22:38:34 | 2026-08 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 84e616aacf4f… | |
| 2026-08-18 06:07:40 | 2026-07 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | caaa826d4ba7… | |
| 2026-02-19 14:30 UTC | 2026-02 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 011fe1cb6892… | |
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 31067a03dcf5… | |
| 2025-08-23 18:47 UTC | 2025-08 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 6a471c1ec25d… | |
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | fd3edfee7708… | |
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | b8a1b40f171c… | |
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 03ed91905a0d… | |
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 2680178bc6a6… | |
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 5bbf6a4d5a75… | |
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | d8e5a09893c0… | |
| 2024-10-29 15:01 UTC | 2024-10 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | d06236e962d9… | |
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 79d66fd596c7… | |
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 301d65b070ca… | |
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 1e350fbaab3a… | |
| 2024-05-31 18:47 UTC | 2024-05 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 8072bd15b7f6… | |
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 5c6f7cd8ea54… | |
| 2022-04-08 23:34 UTC | 2022-04 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 5d02ea3f76ae… | |
| 2022-04-04 05:41 UTC | 2022-04 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 4b0b4de00fa7… | |
| 2019-12-13 00:20 UTC | 2019-12 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 74a2ff9319b5… | |
| 2022-03-09 01:35 UTC | 2022-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | bb7c543d1eb4… | |
| 2021-12-28 21:50 UTC | 2021-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 782e0a99824c… | |
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 87673890dc5c… | |
| 2021-03-12 10:30 UTC | 2021-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 5aa47cf7b7d7… | |
| 2020-12-22 03:56 UTC | 2020-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 8869cabd3fbd… | |
| 2020-11-12 02:37 UTC | 2020-11 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | c0c555d07b60… | |
| 2019-12-14 00:12 UTC | 2019-12 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | 3f01610625f2… | |
| 2019-09-15 20:21 UTC | 2019-09 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | b00525d2431f… | |
| 2019-07-19 19:46 UTC | 2019-07 | N019964-001 | TERAZOL 3 | 0.8% | CREAM / VAGINAL | RLD | 1991-02-21 | ea99ee380514… | |
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 6a51e52b5d6a… | |
| 2024-02-18 07:12 UTC | 2024-02 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 1c564ffb4f44… | |
| 2023-12-20 04:57 UTC | 2023-12 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | ea1830bbd6c7… | |
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | a72a2bbeb626… | |
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 9b2671bbb829… | |
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | a67488948f0b… | |
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 3f0d92c62455… | |
| 2023-05-13 08:27 UTC | 2023-05 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 053a50430f4f… | |
| 2023-01-26 05:58 UTC | 2023-01 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 3bdfa0b2c4d7… | |
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019964-001 | TERAZOL 3 | 0.8% **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** | CREAM / VAGINAL | RLD | 1991-02-21 | 3a93d1ddd44b… |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 9a055cd8-638b-11ea-a644-412efc2ca371 | 6f2626b3-6053-4f7a-bc5d-78e30d983f90 | 2020-05-15 | Warnings, Adverse reactions | 9a055cd8-638b-11ea-a644-412efc2ca371 6f2626b3-6053-4f7a-bc5d-78e30d983f90 |
Adverse event summaries are temporarily unavailable. Other product information remains available.