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
- Safeway, Inc
- Product type
- HUMAN OTC DRUG
- SPL set ID
- f32e5b0f-1fd9-9b33-e053-2995a90a8103
- SPL ID
- 46510bfe-1c72-5f4d-e063-6294a90aa930
- Version
- 6
- Effective date
- 2025-12-19
- Source export date
- 2026-09-28
- 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/2026-09-28/f7d2b6e3f8600cd856280ab55a9c6fa54a642647191d164f9d1110e89f3f4097/drug-label-0002-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 05:14:51
| 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 | Safeway, Inc | openfda.manufacturer_name | |
| ndc | package | 21130-554-27 | openfda.package_ndc |
| ndc | product | 21130-554 | openfda.product_ndc |
| ndc11 | package | 21130055427 | derived:openfda.package_ndc |
| rxcui | 310621 | openfda.rxcui | |
| spl id | 46510bfe-1c72-5f4d-e063-6294a90aa930 | id | |
| spl set id | f32e5b0f-1fd9-9b33-e053-2995a90a8103 | 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.