Home NDC 10572-302 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Product NDC 10572-302
11-digit product format 105720302
Labeler code 10572
Product ID 10572-302_d21af010-592c-bd05-e053-2995a90a3d39
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name polyethylene glycol 3350, sodium chloride, sodium bicarbonate, potassium chloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Affordable Pharmaceuticals, LLC
Application NDA019797
Marketing category NDA AUTHORIZED GENERIC
Marketing start 2013-02-08
Substance POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Active strength 420; 1.48; 5.72; 11.2 g/4L; g/4L; g/4L; g/4L
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Source provenance: Browse the complete Orange Book source catalog · source snapshot 1 .
Orange Book products# Current product rows page 1 of 1 · 2 matching rows.
Application-product, Trade name, Ingredient table Application-product Trade name Ingredient Strength Dosage form / route TE codes RLD / RS Approval date N019797-001 NULYTELY POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 N019797-002 NULYTELY-FLAVORED POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18
Therapeutic equivalence codes# Current TE-code rows page 1 of 1 · 2 matching rows.
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 3 · 82 observed states.
Captured, Edition, Application-product table Captured Edition Application-product Trade name Strength Dosage form / route Product TE source text RLD / RS Approval date Source SHA-256 2026-02-19 14:30 UTC 2026-02 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 011fe1cb6892…2026-02-19 14:30 UTC 2026-02 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 011fe1cb6892…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 31067a03dcf5…2025-12-14 10:44 UTC · 2 captures of this ZIP 2025-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 31067a03dcf5…2025-08-23 18:47 UTC 2025-08 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 6a471c1ec25d…2025-08-23 18:47 UTC 2025-08 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 6a471c1ec25d…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 fd3edfee7708…2025-03-22 03:13 UTC · 3 captures of this ZIP 2025-03 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 fd3edfee7708…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 b8a1b40f171c…2025-02-26 10:13 UTC · 3 captures of this ZIP 2025-02 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 b8a1b40f171c…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 03ed91905a0d…2025-01-19 17:59 UTC · 7 captures of this ZIP 2025-01 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 03ed91905a0d…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 2680178bc6a6…2024-12-13 21:23 UTC · 2 captures of this ZIP 2024-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 2680178bc6a6…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 5bbf6a4d5a75…2024-09-14 05:58 UTC · 2 captures of this ZIP 2024-09 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 5bbf6a4d5a75…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 d8e5a09893c0…2024-11-08 22:44 UTC · 3 captures of this ZIP 2024-11 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 d8e5a09893c0…2024-10-29 15:01 UTC 2024-10 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 d06236e962d9…2024-10-29 15:01 UTC 2024-10 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 d06236e962d9…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 79d66fd596c7…2024-08-13 05:28 UTC · 3 captures of this ZIP 2024-08 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 79d66fd596c7…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 301d65b070ca…2024-07-13 05:37 UTC · 2 captures of this ZIP 2024-07 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 301d65b070ca…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 1e350fbaab3a…2024-06-18 03:08 UTC · 5 captures of this ZIP 2024-06 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 1e350fbaab3a…2024-05-31 18:47 UTC 2024-05 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 8072bd15b7f6…2024-05-31 18:47 UTC 2024-05 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 8072bd15b7f6…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 5c6f7cd8ea54…2022-06-29 02:47 UTC · 2 captures of this ZIP 2022-06 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 5c6f7cd8ea54…2022-04-08 23:34 UTC 2022-04 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 5d02ea3f76ae…2022-04-08 23:34 UTC 2022-04 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 5d02ea3f76ae…2022-04-04 05:41 UTC 2022-04 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 4b0b4de00fa7…2022-04-04 05:41 UTC 2022-04 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 4b0b4de00fa7…2019-12-13 00:20 UTC 2019-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 74a2ff9319b5…2019-12-13 00:20 UTC 2019-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 74a2ff9319b5…2022-03-09 01:35 UTC 2022-03 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 bb7c543d1eb4…2022-03-09 01:35 UTC 2022-03 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 bb7c543d1eb4…2021-12-28 21:50 UTC 2021-12 N019797-001 NULYTELY 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1991-04-22 782e0a99824c…2021-12-28 21:50 UTC 2021-12 N019797-002 NULYTELY-FLAVORED 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT FOR SOLUTION / ORAL AA RLD, RS 1994-11-18 782e0a99824c…
Observed Orange Book normalized TE history# Normalized TE history page 1 of 3 · 82 observed states.
Additional Listing Data#
Finished product Yes
Brand name base PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength POLYETHYLENE GLYCOL 3350 420 g/4L SODIUM CHLORIDE 1.48 g/4L SODIUM BICARBONATE 5.72 g/4L POTASSIUM CHLORIDE 11.2 g/4L
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 4 matching rows.
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 801054 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10572-302-01 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride 4 L in 1 BOTTLE POWDER, FOR SOLUTION 4 4
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded polyethylene glycol 3350 ACTIVE INGREDIENT G2M7P15E5P PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2 potassium chloride ACTIVE INGREDIENT 660YQ98I10 PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2 sodium bicarbonate ACTIVE INGREDIENT 8MDF5V39QO PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2 sodium chloride ACTIVE INGREDIENT 451W47IQ8X PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2 bicarbonate ion ACTIVE MOIETY HN1ZRA3Q20 PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2 chloride ion ACTIVE MOIETY Q32ZN48698 PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2 polyethylene glycol 3350 ACTIVE MOIETY G2M7P15E5P PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10572-302 PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE AND POTASSIUM CHLORIDE (POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [AFFORDABLE PHARMACEUTICALS, LLC] 4 Current NDC, Legacy NDC, 1 package rows 20211202_89ca6d56-527a-4be2-baea-531156f0a7be.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 · 2 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join PEG 3350, sodium chloride, sodium bicarbonate and potassium chloride POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE Wilshire Pharmaceuticals, Inc. 4e442a72-b13b-4869-8a1d-59356095b091 2026-04-14 Warnings, Adverse reactions Exact identifier application applno (NDA): 019797 application number: NDA019797 PEG-3350, sodium chloride, sodium bicarbonate and potassium chloride POLYETHYLENE GLYCOL 3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE Affordable Pharmaceuticals, LLC 89ca6d56-527a-4be2-baea-531156f0a7be 2021-05-03 Warnings, Adverse reactions Exact identifier application applno (NDA): 019797 application number: NDA019797 ndc (product): 10572-302
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 10572-302-01 10572030201 4 L in 1 BOTTLE (10572-302-01) 4 l 2013-03-01 0000-00-00 No No Current