warnings
Do not use for children under 12 years of age
Guaifenesin
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
- Generic name
- GUAIFENESIN
- Manufacturer
- Walgreens
- Product type
- HUMAN OTC DRUG
- SPL set ID
- fd91621b-c969-8851-e053-6294a90ad8b2
- SPL ID
- 46546a5a-8f8f-e73a-e063-6394a90a8330
- Version
- 4
- Effective date
- 2025-12-19
- Source export date
- 2026-10-27
- 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/2026-10-27/29a1aba6a935d72bab5474118c2ccf25cb52dfe8488fe1593c734ea6c04e3722/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- 6be3667a3beefe6c0ead4c723ea963050533a2bc725a8044d58b07d18b258c55
- Import run
- 20261027T193451Z
- Imported at
- 2026-10-27 19:44:53
| 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 applno | ANDA | 213420 | derived:openfda.application_number |
| application number | ANDA213420 | openfda.application_number | |
| brand name | Guaifenesin | openfda.brand_name | |
| generic name | GUAIFENESIN | openfda.generic_name | |
| manufacturer name | Walgreens | openfda.manufacturer_name | |
| ndc | package | 0363-9569-04 | openfda.package_ndc |
| ndc | package | 0363-9569-02 | openfda.package_ndc |
| ndc | product | 0363-9569 | openfda.product_ndc |
| ndc11 | package | 00363956902 | derived:openfda.package_ndc |
| ndc11 | package | 00363956904 | derived:openfda.package_ndc |
| rxcui | 636522 | openfda.rxcui | |
| spl id | 46546a5a-8f8f-e73a-e063-6394a90a8330 | id | |
| spl set id | fd91621b-c969-8851-e053-6294a90ad8b2 | set_id | |
| unii | 495W7451VQ | 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.