Neo-Synalar
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
- Neo-Synalar
- Generic name
- NEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDE
- Manufacturer
- Eurofarma, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- SPL set ID
- 1141956e-8a4c-4f80-95d1-f15bdb57fdf6
- SPL ID
- b176bc29-53fc-48a1-bf09-ba250f1d13d7
- Version
- 5
- Effective date
- 2026-03-18
- Source export date
- 2026-09-28
- Source partition
- 8
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:56:02
| 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 | 060700 | derived:openfda.application_number |
| application number | ANDA060700 | openfda.application_number | |
| brand name | Neo-Synalar | openfda.brand_name | |
| generic name | NEOMYCIN SULFATE AND FLUOCINOLONE ACETONIDE | openfda.generic_name | |
| manufacturer name | Eurofarma, Inc. | openfda.manufacturer_name | |
| ndc | package | 43538-940-60 | openfda.package_ndc |
| ndc | package | 43538-940-99 | openfda.package_ndc |
| ndc | product | 43538-940 | openfda.product_ndc |
| ndc11 | package | 43538094060 | derived:openfda.package_ndc |
| ndc11 | package | 43538094099 | derived:openfda.package_ndc |
| rxcui | 1542994 | openfda.rxcui | |
| rxcui | 1191359 | openfda.rxcui | |
| spl id | b176bc29-53fc-48a1-bf09-ba250f1d13d7 | id | |
| spl set id | 1141956e-8a4c-4f80-95d1-f15bdb57fdf6 | set_id | |
| unii | 0CD5FD6S2M | openfda.unii | |
| unii | 057Y626693 | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS If local infection should continue or become severe, or in the presence of systemic infection, appropriate systemic antibacterial therapy, based on susceptibility testing, should be considered. Because of the concern of nephrotoxicity and ototoxicity associated with neomycin, this combination product should not be used over a wide area or for extended periods of time. There are articles in the current medical literature that indicate an increase in the prevalence of persons sensitive to neomycin.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: Burning Hypertrichosis Maceration of the skin Itching Acneiform eruptions Secondary infection Irritation Hypopigmentation Skin atrophy Dryness Perioral dermatitis Striae Folliculitis Allergic contact dermatitis Miliaria The following adverse reactions have been reported with the topical use of neomycin: Ototoxicity Nephrotoxicity
adverse reactions table
<table width="80%" styleCode="Noautorules"><col width="32%" align="left" valign="middle"/><col width="34%" align="left" valign="middle"/><col width="34%" align="left" valign="middle"/><tbody><tr><td> Burning</td><td>Hypertrichosis</td><td>Maceration of the skin</td></tr><tr><td> Itching</td><td>Acneiform eruptions</td><td>Secondary infection</td></tr><tr><td> Irritation</td><td>Hypopigmentation</td><td>Skin atrophy</td></tr><tr><td> Dryness</td><td>Perioral dermatitis</td><td>Striae</td></tr><tr><td> Folliculitis</td><td>Allergic contact dermatitis</td><td>Miliaria</td></tr></tbody></table>
adverse reactions table
<table width="80%" styleCode="Noautorules"><col width="32%" align="left" valign="middle"/><col width="68%" align="left" valign="middle"/><tbody><tr><td> Ototoxicity</td><td>Nephrotoxicity</td></tr></tbody></table>
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.