warnings
WARNINGS None.
Terconazole Vaginal Cream 0.8%
openFDA label record#
This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.
Verified complete openFDA source JSON
- Brand name
- Terconazole Vaginal Cream 0.8%
- Generic name
- TERCONAZOLE
- Manufacturer
- A-S Medication Solutions
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 9b1c38ac-ebf3-471c-bcdf-1ff8ad197f91
- SPL ID
- 8878f816-8262-4172-b007-ce8e7ac089bb
- Version
- 1
- Effective date
- 2023-01-03
- Source export date
- 2026-10-12
- Source partition
- 11
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 02:39:30
| Harmonized routes |
|---|
| VAGINAL |
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| application applno | NDA | 021735 | derived:openfda.application_number |
| application number | NDA021735 | openfda.application_number | |
| brand name | Terconazole Vaginal Cream 0.8% | openfda.brand_name | |
| generic name | TERCONAZOLE | openfda.generic_name | |
| manufacturer name | A-S Medication Solutions | openfda.manufacturer_name | |
| ndc | package | 50090-6299-0 | openfda.package_ndc |
| ndc | product | 50090-6299 | openfda.product_ndc |
| ndc11 | package | 50090629900 | derived:openfda.package_ndc |
| rxcui | 313227 | openfda.rxcui | |
| spl id | 8878f816-8262-4172-b007-ce8e7ac089bb | id | |
| spl set id | 9b1c38ac-ebf3-471c-bcdf-1ff8ad197f91 | set_id | |
| unii | 0KJ2VE664U | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS During controlled clinical studies conducted in the United States, patients with vulvovaginal candidiasis were treated with terconazole vaginal cream 0.8% for 3 days. Based on comparative analyses with placebo and a standard agent, the adverse experiences considered most likely related to terconazole vaginal cream 0.8% were headache (21% vs 16% with placebo) and dysmenorrhea (6% vs 2% with placebo). Genital complaints in general, and burning and itching in particular, occurred less frequently in the terconazole vaginal cream 0.8% 3 day regimen (5% vs. 6%-9% with placebo). Other adverse experiences reported with terconazole vaginal cream 0.8% were abdominal pain (3.4% vs. 1% with placebo) and fever (1% vs. 0.3% with placebo). The therapy-related dropout rate was 2.0% for the terconazole vaginal cream 0.8%. The adverse drug experience most frequently causing discontinuation of therapy was vulvovaginal itching, 0.7% with the terconazole vaginal cream 0.8% group and 0.3% with the placebo group.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.