GAVILAX

Product NDC
17856-0312
11-digit product format
178560312
Labeler code
17856
Product ID
17856-0312_3a86670e-4e74-3a85-e063-6394a90ad435
Type
HUMAN OTC DRUG
Nonproprietary name
Polyethylene Glycol 3350
Dosage form
POWDER, FOR SOLUTION
Route
ORAL
Labeler
ATLANTIC BIOLOGICALS CORP.
Application
ANDA091077
Marketing category
ANDA
Marketing start
2021-01-26
Substance
POLYETHYLENE GLYCOL 3350
Active strength
17 g/17g
Pharmacologic classes
Osmotic Activity [MoA], Osmotic Laxative [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2025-02-02 03:52 UTC · source 2025-01-31excluded productproduct302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-6302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-3302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-1302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-4302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-7302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-2302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-31excluded packagepackage17856-0312-5302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20excluded productproducted331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-6ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-3ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-1ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-4ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-7ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-2ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-20excluded packagepackage17856-0312-5ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-60efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-30efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-10efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-40efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-70efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-20efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage17856-0312-50efc9e666f02…f202fb6c5f17…

Source provenance: Browse the complete Orange Book source catalog · source snapshot 42.

Orange Book products#

Current product rows page 1 of 1 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A091077-001POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06
A091077-002POLYETHYLENE GLYCOL 3350POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 46 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06caaa826d4ba7…
2026-08-18 06:07:402026-07A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06011fe1cb6892…
2026-02-19 14:30 UTC2026-02A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-27011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0631067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A091077-002POLYETHYLENE GLYCOL 335017GM/PACKETFOR SOLUTION / ORAL2011-06-2731067a03dcf5…
2025-08-23 18:47 UTC2025-08A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0603ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-062680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0679d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061e350fbaab3a…
2024-05-31 18:47 UTC2024-05A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-064b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0674a2ff9319b5…
2022-03-09 01:35 UTC2022-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-0687673890dc5c…
2021-03-12 10:30 UTC2021-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-065aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-068869cabd3fbd…
2020-11-12 02:37 UTC2020-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06c0c555d07b60…
2019-12-14 00:12 UTC2019-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063f01610625f2…
2019-09-15 20:21 UTC2019-09A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06b00525d2431f…
2019-07-19 19:46 UTC2019-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-066a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-061c564ffb4f44…
2023-12-20 04:57 UTC2023-12A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-069b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063f0d92c62455…
2023-05-13 08:27 UTC2023-05A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-06053a50430f4f…
2023-01-26 05:58 UTC2023-01A091077-001POLYETHYLENE GLYCOL 335017GM/SCOOPFULFOR SOLUTION / ORAL2009-10-063bdfa0b2c4d7…

Additional Listing Data#

Finished product
Yes
Brand name base
GAVILAX
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POLYETHYLENE GLYCOL 335017 g/17g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
G2M7P15E5PInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
876193Internal RxNorm lookup
876214Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
c9688f06-b6db-4afb-b8ff-ef5fb8bf9946Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

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 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

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

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 1 of 1 · 7 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GAVILAXPOLYETHYLENE GLYCOL 3350Atlantic Biologicals Corp.4c207478-6f0f-c3cf-e063-6394a90aa4f22026-06-04WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
GAVILAXPOLYETHYLENE GLYCOL 3350Preferred Pharmaceuticals, Inc.21654def-5ae0-422d-961b-1fe2456af00a2026-05-04WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
GAVILAXPOLYETHYLENE GLYCOL 3350Lupin Pharmaceuticals,Inc.19672e23-1606-497e-a112-939af33af1952025-12-08WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
GAVILAXPOLYETHYLENE GLYCOL 3350ATLANTIC BIOLOGICALS CORP.c9688f06-b6db-4afb-b8ff-ef5fb8bf99462025-07-22WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
ndc (product): 17856-0312
GAVILAXPOLYETHYLENE GLYCOL 3350A-S Medication Solutions581baa4b-7331-47a3-81c6-680286f03aca2025-01-09WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
GAVILAXPOLYETHYLENE GLYCOL 3350Proficient Rx LP199d6173-3fad-49e4-88fe-bde7223ed4c32022-06-01WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077
Polyethylene GlycolPOLYETHYLENE GLYCOLBluePoint Laboratoriesc4cae70c-68da-0bbc-e053-2a95a90a395a2021-09-20WarningsExact identifier
application applno (ANDA): 091077
application number: ANDA091077

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
876214GaviLAX 17 GM Powder for Oral SolutionPSNc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionPSNc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876214polyethylene glycol 3350 17000 MG Powder for Oral Solution [Gavilax]SBDc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876193polyethylene glycol 3350 17000 MG Powder for Oral SolutionSCDc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876214Gavilax 17 GM Powder for Oral SolutionSYc9688f06-b6db-4afb-b8ff-ef5fb8bf994614
876193polyethylene glycol 3350 17 GM Powder for Oral SolutionSYc9688f06-b6db-4afb-b8ff-ef5fb8bf994614

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
17856-0312-11785603120117 g in 1 BAG (17856-0312-1) 17 g2021-01-260000-00-00NoNoCurrent
17856-0312-2178560312028.5 g in 1 BAG (17856-0312-2) 8.5 g2021-01-260000-00-00NoNoCurrent
17856-0312-31785603120317 g in 1 CUP (17856-0312-3) 17 g2021-01-260000-00-00NoNoCurrent
17856-0312-4178560312044 g in 1 BAG (17856-0312-4) 4 g2021-01-260000-00-00NoNoCurrent
17856-0312-51785603120550 CUP in 1 CASE (17856-0312-5) / 8.5 g in 1 CUP50 cup2021-01-260000-00-00NoNoCurrent
17856-0312-61785603120672 POUCH in 1 CASE (17856-0312-6) / 4.5 g in 1 POUCH72 pouch2021-01-260000-00-00NoNoCurrent
17856-0312-71785603120750 BAG in 1 BOX, UNIT-DOSE (17856-0312-7) / 4.25 g in 1 BAG50 bag2023-10-10NoNoCurrent
17856-0312-81785603120872 BAG in 1 BOX, UNIT-DOSE (17856-0312-8) / 4.25 g in 1 BAG72 bag2025-07-22NoNoCurrent
17856-0312-91785603120950 CUP in 1 BOX, UNIT-DOSE (17856-0312-9) / 4.25 g in 1 CUP50 cup2025-07-22NoNoCurrent