warnings
Warnings For External Use Only
OsmoFlex
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
- OsmoFlex
- Generic name
- MENTHOL
- Manufacturer
- Sarati International, Inc.
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e
- SPL ID
- 08b4632c-2421-6046-e063-6294a90a1527
- Version
- 7
- Effective date
- 2023-10-27
- Source export date
- 2026-10-12
- Source partition
- 4
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:37:01
| 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 number | M017 | openfda.application_number | |
| brand name | OsmoFlex | openfda.brand_name | |
| generic name | MENTHOL | openfda.generic_name | |
| manufacturer name | Sarati International, Inc. | openfda.manufacturer_name | |
| ndc | package | 67676-101-01 | openfda.package_ndc |
| ndc | package | 67676-101-04 | openfda.package_ndc |
| ndc | package | 67676-101-03 | openfda.package_ndc |
| ndc | product | 67676-101 | openfda.product_ndc |
| ndc11 | package | 67676010101 | derived:openfda.package_ndc |
| ndc11 | package | 67676010104 | derived:openfda.package_ndc |
| ndc11 | package | 67676010103 | derived:openfda.package_ndc |
| rxcui | 1050947 | openfda.rxcui | |
| rxcui | 436147 | openfda.rxcui | |
| spl id | 08b4632c-2421-6046-e063-6294a90a1527 | id | |
| spl set id | 479147c0-4cf4-4d7a-8b8e-1a0de49ed73e | set_id | |
| unii | L7T10EIP3A | openfda.unii |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.