warnings
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
- Aurohealth LLC
- Product type
- HUMAN OTC DRUG
- SPL set ID
- c3533119-b307-4bad-8c79-254fea08402b
- SPL ID
- 209f74eb-400d-40fe-943e-cecd8aec3a1d
- Version
- 8
- Effective date
- 2024-10-28
- Source export date
- 2026-09-28
- Source partition
- 12
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:24:50
| 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 | 210453 | derived:openfda.application_number |
| application number | ANDA210453 | openfda.application_number | |
| brand name | Guaifenesin | openfda.brand_name | |
| generic name | GUAIFENESIN | openfda.generic_name | |
| manufacturer name | Aurohealth LLC | openfda.manufacturer_name | |
| ndc | package | 58602-811-01 | openfda.package_ndc |
| ndc | package | 58602-811-56 | openfda.package_ndc |
| ndc | package | 58602-811-73 | openfda.package_ndc |
| ndc | package | 58602-811-64 | openfda.package_ndc |
| ndc | package | 58602-811-02 | openfda.package_ndc |
| ndc | package | 58602-811-05 | openfda.package_ndc |
| ndc | package | 58602-811-60 | openfda.package_ndc |
| ndc | package | 58602-811-21 | openfda.package_ndc |
| ndc | package | 58602-811-12 | openfda.package_ndc |
| ndc | package | 58602-811-03 | openfda.package_ndc |
| ndc | package | 58602-811-57 | openfda.package_ndc |
| ndc | product | 58602-811 | openfda.product_ndc |
| ndc11 | package | 58602081112 | derived:openfda.package_ndc |
| ndc11 | package | 58602081160 | derived:openfda.package_ndc |
| ndc11 | package | 58602081157 | derived:openfda.package_ndc |
| ndc11 | package | 58602081173 | derived:openfda.package_ndc |
| ndc11 | package | 58602081103 | derived:openfda.package_ndc |
| ndc11 | package | 58602081101 | derived:openfda.package_ndc |
| ndc11 | package | 58602081164 | derived:openfda.package_ndc |
| ndc11 | package | 58602081156 | derived:openfda.package_ndc |
| ndc11 | package | 58602081121 | derived:openfda.package_ndc |
| ndc11 | package | 58602081102 | derived:openfda.package_ndc |
| ndc11 | package | 58602081105 | derived:openfda.package_ndc |
| rxcui | 310621 | openfda.rxcui | |
| spl id | 209f74eb-400d-40fe-943e-cecd8aec3a1d | id | |
| spl set id | c3533119-b307-4bad-8c79-254fea08402b | 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.