warnings
WARNINGS Acyclovir ointment 5% is intended for cutaneous use only and should not be used in the eye.
ACYCLOVIR
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
- ACYCLOVIR
- Generic name
- ACYCLOVIR
- Manufacturer
- Solco Healthcare US, LLC
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- a1d7b8ec-309d-447e-ae05-b9e89cc29948
- SPL ID
- a1d7b8ec-309d-447e-ae05-b9e89cc29948
- Version
- 1
- Effective date
- 2021-11-15
- Source export date
- 2026-08-01
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-08-01/63703fa640102c69d41ceeb8d73f46d0a0be448587814b2aeca60b43bed7e054/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
- Import run
- 20260801T225920Z
- Imported at
- 2026-08-01 23:37:52
| Harmonized routes |
|---|
| TOPICAL |
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 | ANDA | 212202 | derived:openfda.application_number |
| application number | ANDA212202 | openfda.application_number | |
| brand name | ACYCLOVIR | openfda.brand_name | |
| generic name | ACYCLOVIR | openfda.generic_name | |
| manufacturer name | Solco Healthcare US, LLC | openfda.manufacturer_name | |
| ndc | package | 43547-499-41 | openfda.package_ndc |
| ndc | package | 43547-499-42 | openfda.package_ndc |
| ndc | product | 43547-499 | openfda.product_ndc |
| ndc11 | package | 43547049942 | derived:openfda.package_ndc |
| ndc11 | package | 43547049941 | derived:openfda.package_ndc |
| rxcui | 197312 | openfda.rxcui | |
| spl id | a1d7b8ec-309d-447e-ae05-b9e89cc29948 | id | |
| spl set id | a1d7b8ec-309d-447e-ae05-b9e89cc29948 | set_id | |
| unii | X4HES1O11F | 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 In the controlled clinical trials, mild pain (including transient burning and stinging) was reported by about 30% of patients in both the active and placebo arms; treatment was discontinued in 2 of these patients. Local pruritus occurred in 4% of these patients. In all studies, there was no significant difference between the drug and placebo group in the rate or type of reported adverse reactions nor were there any differences in abnormal clinical laboratory findings. Observed During Clinical Practice: Based on clinical practice experience in patients treated with acyclovir ointment in the U.S., spontaneously reported adverse events are uncommon. Data are insufficient to support an estimate of their incidence or to establish causation. These events may also occur as part of the underlying disease process. Voluntary reports of adverse events that have been received since market introduction include: General: Edema and/or pain at the application site. Skin: Pruritus, rash. To report SUSPECTED ADVERSE REACTIONS, contact Solco Healthcare US, LLC at 1-866-257-2597 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .