Guaifenesin 400
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
- Guaifenesin 400
- Generic name
- GUAIFENESIN TABLETS 400
- Manufacturer
- InvaTech Pharma Solutions LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- 40291505-55ca-0759-e063-6394a90acee1
- SPL ID
- 4029150e-7782-a118-e063-6294a90a09c1
- Version
- 5
- Effective date
- 2025-10-02
- Source export date
- 2026-10-12
- Source partition
- 2
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
- Import run
- 20261013T011858Z
- Imported at
- 2026-10-13 01:27:32
| Harmonized routes |
|---|
| ORAL |
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 | M012 | openfda.application_number | |
| brand name | Guaifenesin 400 | openfda.brand_name | |
| generic name | GUAIFENESIN TABLETS 400 | openfda.generic_name | |
| manufacturer name | InvaTech Pharma Solutions LLC | openfda.manufacturer_name | |
| ndc | package | 57631-012-00 | openfda.package_ndc |
| ndc | product | 57631-012 | openfda.product_ndc |
| ndc11 | package | 57631001200 | derived:openfda.package_ndc |
| rxcui | 359601 | openfda.rxcui | |
| spl id | 4029150e-7782-a118-e063-6294a90a09c1 | id | |
| spl set id | 40291505-55ca-0759-e063-6394a90acee1 | set_id | |
| unii | 495W7451VQ | openfda.unii |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.