Home NDC 52268-302 NuLYTELY
Product NDC 52268-302
11-digit product format 522680302
Labeler code 52268
Product ID 52268-302_e190c47f-b1d3-4624-e053-2a95a90a2eba
Type HUMAN PRESCRIPTION DRUG
Nonproprietary name polyethylene glycol 3350, sodium chloride, sodium bicarbonate and potassium chloride
Dosage form POWDER, FOR SOLUTION
Route ORAL
Labeler Braintree Laboratories, Inc.
Application NDA019797
Marketing category NDA
Marketing start 1991-04-22
Marketing end 2024-08-31
Substance POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
Active strength 420 g/4L; g/4L; g/4L; g/4L
Pharmacologic classes Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [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 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 0000-00-00
Current FDA listing Historical FDA.report record 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 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 52268-302-01 d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 52268-302-01 f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 52268-302-01 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 52268-302-01 a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 52268-302-01 cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 52268-302-01 cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 52268-302-01 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 52268-302-01 ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 52268-302-01 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 52268-302-01 ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 52268-302-01 367a005e9d99…383a685ebd0f…
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.
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
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 52268-302-01 52268030201 4 L in 1 PACKAGE (52268-302-01) 4 l 1991-04-22 0000-00-00 No No Current