Guaifenesin STRAWBERRY-BANANA FLAVOR
NDC product · U.S. Food and Drug Administration (openFDA) · United States
-
Product NDC
71800-059 -
Package NDC
71800-059-19 -
Application number
M012 -
SPL ID
37de006a-e717-a4e5-e063-6394a90abd8b -
SPL set ID
1006906e-d6d7-4f49-92bf-3cb2d2cdbb16 -
UNII
495W7451VQ -
RxCUI
310604
What the source publishes
- Labeler
- Innovida Pharmaeutique Corporation
- Active ingredients
- GUAIFENESIN
- Form
- LIQUID
- Routes
- ORAL
- Administrative status
- present-in-source-snapshot
- Marketing status
- OTC MONOGRAPH DRUG
- Product type
- HUMAN OTC DRUG
- Prescription
- Non-prescription
Names this record is found by
Complete source data
{
"name": "Guaifenesin STRAWBERRY-BANANA FLAVOR",
"splId": "37de006a-e717-a4e5-e063-6394a90abd8b",
"labels": [
{
"setId": "1006906e-d6d7-4f49-92bf-3cb2d2cdbb16",
"labelUrl": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1006906e-d6d7-4f49-92bf-3cb2d2cdbb16",
"labelPdfUrl": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=1006906e-d6d7-4f49-92bf-3cb2d2cdbb16"
}
],
"routes": [
"ORAL"
],
"labeler": "Innovida Pharmaeutique Corporation",
"finished": true,
"packaging": [
{
"sample": false,
"description": "119 mL in 1 TUBE (71800-059-19)",
"package_ndc": "71800-059-19",
"identifierStatus": "well-formed",
"marketing_start_date": "20250616"
}
],
"productId": "71800-059_37de006a-e717-a4e5-e063-6394a90abd8b",
"useDomain": "unknown",
"dosageForm": "LIQUID",
"productNdc": "71800-059",
"deaSchedule": null,
"genericName": "GUAIFENESIN",
"productType": "HUMAN OTC DRUG",
"listingStatus": "present-in-source-snapshot",
"targetSpecies": [],
"approvalStatus": "not-established-by-ndc-listing",
"labelAssociation": "openFDA-harmonized-set-ids; not a product-level approval match",
"marketingEndDate": null,
"activeIngredients": [
{
"name": "GUAIFENESIN",
"strength": "100 mg/5mL"
}
],
"applicationNumber": "M012",
"marketingCategory": "OTC MONOGRAPH DRUG",
"stateRestrictions": {
"status": "not-collected",
"observations": []
},
"useDomainEvidence": {
"basis": "unreviewed",
"field": null,
"value": null,
"version": 1,
"sourceId": "us.fda.ndc"
},
"marketingStartDate": "20250616",
"targetSpeciesStatus": "not-reported",
"prescriptionCategory": "non-prescription",
"harmonizedIdentifiers": {
"nui": [
"N0000193956",
"N0000008867",
"N0000009560"
],
"unii": [
"495W7451VQ"
],
"rxcui": [
"310604"
],
"spl_set_id": [
"1006906e-d6d7-4f49-92bf-3cb2d2cdbb16"
],
"pharm_class_pe": [
"Decreased Respiratory Secretion Viscosity [PE]",
"Increased Respiratory Secretions [PE]"
],
"pharm_class_epc": [
"Expectorant [EPC]"
],
"manufacturer_name": [
"Innovida Pharmaeutique Corporation"
],
"is_original_packager": [
true
]
},
"listingExpirationDate": "20261231"
}
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