🇺🇸
United States · US · US:11523-4357_51040c1b-71bf-bb83-e063-6294a90aca4e
MiraLAX
Orange BookUNIISPL
Last synced from FDA National Drug Code directory (United States) on
Identification
ManufacturerBayer HealthCare LLC.
CountryUS (United States)
ATC code—
Dispensing—
ReimbursedNo
SourceFDA National Drug Code directory (United States)
Last synced6/3/2026
Packs · 3
- ndc1111523435722 CARTON in 1 CARTON (11523-4357-2) / 20 PACKET in 1 CARTON / 17 g in 1 PACKET
- ndc1111523435732 BOTTLE, PLASTIC in 1 PACKAGE, COMBINATION (11523-4357-3) / 578 g in 1 BOTTLE, PLASTIC
- ndc11115234357524 PACKET in 1 CARTON (11523-4357-5) / 17 g in 1 PACKET
Annotations
UNII (FDA Substance ID)
G2M7P15E5P
POLYETHYLENE GLYCOL 3350
RxCUI 221147
Orange Book
N022015
DailyMed SPL labels
1 version tracked
Raw payload (JSON)
{
"unii": {
"unii": "G2M7P15E5P",
"rxcui": "221147",
"inchikey": null,
"display_name": "POLYETHYLENE GLYCOL 3350",
"substance_type": "polymer",
"ingredient_type": "INGREDIENT SUBSTANCE"
},
"route": "ORAL",
"spl_meta": {
"d69ce3d4-7ca4-4fe3-b49e-6655e48d6963": {
"match": "brand_token",
"title": "MIRALAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [BAYER HEALTHCARE LLC.]",
"spl_version": "24",
"published_date": "2026-05-06"
}
},
"productid": "11523-4357_51040c1b-71bf-bb83-e063-6294a90aca4e",
"productndc": "11523-4357",
"dosage_form": "POWDER, FOR SOLUTION",
"orange_book": {
"appl_no": "022015",
"products": [
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "17GM/SCOOPFUL",
"product_no": "001",
"approval_date": "Oct 6, 2006"
},
{
"rs": true,
"rld": true,
"te_code": null,
"strength": "17GM/PACKET",
"product_no": "002",
"approval_date": "Oct 6, 2006"
}
],
"appl_type": "N"
},
"dea_schedule": null,
"product_type": "HUMAN OTC DRUG",
"substance_name": "POLYETHYLENE GLYCOL 3350",
"proprietary_name": "MiraLAX",
"active_ingred_unit": "g/17g",
"application_number": "NDA022015",
"marketing_category": "NDA",
"nonproprietary_name": "Polyethylene Glycol 3350",
"start_marketing_date": "20070201",
"active_numerator_strength": "17"
}Access this data programmatically
Query MiraLAX and 610,000+ other drug records through a single REST API — with a last_synced_at provenance stamp on every response. Free tier includes 100 requests/day.