FDA.reportPublic FDA data

NDC 17856-0312-08 - GAVILAX

This NDC is not currently matched to an FDA NDC product listing in FDA.report, but it is a valid NDC-form code. FDA.report is showing the available DailyMed label context for the product root.

Product NDC
17856-0312
Requested NDC
17856-0312-08
Package NDCs from labels
17856-0312-1, 17856-0312-2, 17856-0312-3, 17856-0312-4, 17856-0312-7, 17856-0312-5, 17856-0312-6, 17856-0312-8, 17856-0312-9, 17856-0312-08
Manufacturer
ATLANTIC BIOLOGICALS CORP.
Effective date
2025-07-22
Current FDA listing
Not matched in FDA.report NDC product tables

DailyMed Labels#

Label, Manufacturer, Effective date table
LabelManufacturerEffective dateType
Gavilax Powder Solution Drug FactsATLANTIC BIOLOGICALS CORP.2025-07-22HUMAN OTC DRUG LABEL

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
17856-0312-12025-03-04Gavilax Powder Solution Drug Facts
17856-0312-22025-03-04Gavilax Powder Solution Drug Facts
17856-0312-32025-03-04Gavilax Powder Solution Drug Facts
17856-0312-42025-03-04Gavilax Powder Solution Drug Facts
17856-0312-52025-03-04Gavilax Powder Solution Drug Facts
17856-0312-62025-03-04Gavilax Powder Solution Drug Facts
17856-0312-72025-03-04Gavilax Powder Solution Drug Facts
17856-0312-12025-01-30Gavilax Powder Solution Drug Facts
17856-0312-22025-01-30Gavilax Powder Solution Drug Facts
17856-0312-32025-01-30Gavilax Powder Solution Drug Facts
17856-0312-42025-01-30Gavilax Powder Solution Drug Facts
17856-0312-52025-01-30Gavilax Powder Solution Drug Facts
17856-0312-62025-01-30Gavilax Powder Solution Drug Facts
17856-0312-72025-01-30Gavilax Powder Solution Drug Facts
17856-0312-12023-10-10Gavilax Powder Solution Drug Facts
17856-0312-22023-10-10Gavilax Powder Solution Drug Facts
17856-0312-32023-10-10Gavilax Powder Solution Drug Facts
17856-0312-42023-10-10Gavilax Powder Solution Drug Facts
17856-0312-52023-10-10Gavilax Powder Solution Drug Facts
17856-0312-62023-10-10Gavilax Powder Solution Drug Facts
17856-0312-12023-01-30Gavilax Powder Solution Drug Facts
17856-0312-22023-01-30Gavilax Powder Solution Drug Facts
17856-0312-32023-01-30Gavilax Powder Solution Drug Facts
17856-0312-42023-01-30Gavilax Powder Solution Drug Facts
17856-0312-52023-01-30Gavilax Powder Solution Drug Facts
17856-0312-62023-01-30Gavilax Powder Solution Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
17856-0312-1GAVILAX17 g in 1 BAGPOWDER, FOR SOLUTION1714
17856-0312-2GAVILAX8.5 g in 1 BAGPOWDER, FOR SOLUTION8.514
17856-0312-3GAVILAX17 g in 1 CUPPOWDER, FOR SOLUTION1714
17856-0312-4GAVILAX4 g in 1 BAGPOWDER, FOR SOLUTION414
17856-0312-5GAVILAX8.5 g in 1 CUPPOWDER, FOR SOLUTION8.514
17856-0312-5GAVILAX50 in 1 CASEPOWDER, FOR SOLUTION5014
17856-0312-6GAVILAX72 in 1 CASEPOWDER, FOR SOLUTION7214
17856-0312-6GAVILAX4.5 g in 1 POUCHPOWDER, FOR SOLUTION4.514
17856-0312-7GAVILAX4.25 g in 1 BAGPOWDER, FOR SOLUTION4.2514
17856-0312-7GAVILAX50 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION5014
17856-0312-8GAVILAX72 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION7214
17856-0312-8GAVILAX4.25 g in 1 BAGPOWDER, FOR SOLUTION4.2514
17856-0312-9GAVILAX4.25 g in 1 CUPPOWDER, FOR SOLUTION4.2514
17856-0312-9GAVILAX50 in 1 BOX, UNIT-DOSEPOWDER, FOR SOLUTION5014

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
17856-0312GAVILAX (POLYETHYLENE GLYCOL 3350) POWDER, FOR SOLUTION [ATLANTIC BIOLOGICALS CORP.]11Current NDC, Legacy NDC, 14 package rows20250529_c9688f06-b6db-4afb-b8ff-ef5fb8bf9946.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
17856-0312-1EA - Each17856-03122207a097-3cbf-4c66-9606-5314f8ea385e12016-04-04
17856-0312-2EA - Each17856-0312461d158a-8bd4-4386-89f9-2aab4b3d5dd712016-04-04
17856-0312-5EA - Each17856-03127ad8a14d-8374-41b3-9796-93916cd3d28e12024-05-16
17856-0312-6EA - Each17856-031235018d5e-acba-4c4d-a224-fc921c1f7e2812025-06-13

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 2 of 6 · 105 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
365 WHOLE FOODS MARKET Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Whole Foods Market, Inc.b19f42a9-18ac-4d23-87b5-3c43e47c40542026-06-05WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
application number: ANDA091077
rxcui: 876214
rxcui: 876193
unii: G2M7P15E5P
Polyethylene glycol 3350POLYETHYLENE GLYCOL 3350Major Pharmaceuticalsddc9d2b1-87d8-44fa-bac6-0a7261f335642026-05-12WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
smooth laxPOLYETHYLENE GLYCOL 3350Walgreen Company3027af65-2f7f-472d-83f5-254d5d75013c2026-05-08WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
MiraLAXPOLYETHYLENE GLYCOL 3350Bayer HealthCare LLC.d69ce3d4-7ca4-4fe3-b49e-6655e48d69632026-05-04WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
application number: ANDA091077
rxcui: 876214
rxcui: 876193
unii: G2M7P15E5P
POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 3350CARDINAL HEALTH 110, LLC. DBA LEADER04cc4f2e-1725-4710-8cfb-73a6bdf52e4f2026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurobindo Pharma Limitedb51f2223-8266-4d6c-bf32-58e53e73b54d2026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
COMFORTLAXPOLYETHYLENE GLYCOL 3350Family Dollar Stores, LLC02a44a41-0039-f6ec-e063-6394a90ae6f12026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Aurohealth LLCd3c77f3f-57aa-4e2d-88aa-731cbb22af702026-04-23WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
PEG 3350 and ElectrolytesPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.b251752d-7750-482a-9364-0acf4ad47cc82026-04-16Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
GoLYTELYPOLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDEAzurity Pharmaceuticals, Inc.7609ecf7-0ce0-4fbb-9c27-30987f6895752026-04-15Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
TRILYTEPOLYETHYLENE GLYOCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDEAurobindo Pharma Limited79f5e596-8d51-4227-afcc-f5e3411509572026-04-15Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
PEG 3350, sodium chloride, sodium bicarbonate and potassium chloridePOLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDEWilshire Pharmaceuticals, Inc.4e442a72-b13b-4869-8a1d-59356095b0912026-04-14Warnings, Adverse reactionsExact identifier
unii: G2M7P15E5P
clear laxPOLYETHYLENE GLYCOL 3350Meijer Distribution Inc6464f12c-0883-46c5-943b-a84fe235588e2026-04-13WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Polyethylene Glycol (3350)POLYETHYLENE GLYCOL (3350)Mylan Institutional Inc.219bcbc4-b84a-4209-9f34-ef2b0ef0d2732026-04-08WarningsExact identifier
rxcui: 876193
equate clear laxPOLYETHYLENE GLYCOL 3350Wal-Mart Stores Inc56a507f3-0cd1-4f02-9dfd-de297ba4bc1f2026-03-27WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
foster and thrive clearlaxPOLYETHYLENE GLYCOL 3350Strategic Sourcing Services LLC684e35cc-5a4f-458d-b5e7-e1933fea11392026-03-07WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
ez2go Polyethylene Glycol 3350POLYETHYLENE GLYCOL 3350Valley Medical Products, LLCd64517d6-b0cc-4ba2-b260-e52faa8d4e782026-02-20WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P
Topcare ClearLaxPOLYETHYLENE GLYCOL 3350Topco Associates LLC03291fd3-7b64-4b79-ad84-e1b9b30a6b032026-02-19WarningsExact identifier
rxcui: 876193
unii: G2M7P15E5P

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.