Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate

Product NDC: 40032-050
11-digit product format: 400320050
Labeler code: 40032
Product ID: 40032-050_0cb089b8-0127-4f5f-8b8d-77bc93409747
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Novel Laboratories, Inc.
Application: ANDA090019
Marketing category: ANDA
Marketing start: 2009-05-28
Marketing end: 0000-00-00
Substance: POLYETHYLENE GLYCOL 3350; SODIUM CHLORIDE; SODIUM BICARBONATE; POTASSIUM CHLORIDE
Active strength: 420 g/438.4g; g/438.4g; g/438.4g; g/438.4g
Pharmacologic classes: Osmotic Activity [MoA],Osmotic Laxative [EPC],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA]
NDC exclude flag: E
Listing certified through: 2017-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	40032-050		I	Inactivated by FDA		2026-08-10
excluded package	package	40032-050	40032-050-19	I	Inactivated by FDA		2026-08-10

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 · 44 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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`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	40032-050-19	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	40032-050-19	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	40032-050-19	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	40032-050-19	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	40032-050-19	`1332a3947898…`	`d4bfe170f9cd…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded product	product		`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-08-30 03:57 UTC · source 2022-08-29	excluded package	package	40032-050-19	`fb8cb913e6d1…`	`eb8c232b6be0…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded product	product		`86f5da6cb304…`	`a595104c45d7…`
2022-04-09 23:13 UTC · source 2022-04-08	excluded package	package	40032-050-19	`86f5da6cb304…`	`a595104c45d7…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded product	product		`bd6a592717d7…`	`303034d00443…`
2022-04-04 05:40 UTC · source 2022-04-01	excluded package	package	40032-050-19	`bd6a592717d7…`	`303034d00443…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded product	product		`8dfbde2a14a4…`	`c9ff85d89658…`
2021-12-27 23:28 UTC · source 2021-12-27	excluded package	package	40032-050-19	`8dfbde2a14a4…`	`c9ff85d89658…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded product	product		`e2bbac7714bc…`	`27bdfed8d636…`
2020-12-18 03:04 UTC · source 2020-12-17	excluded package	package	40032-050-19	`e2bbac7714bc…`	`27bdfed8d636…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded product	product		`9bebd1f3094a…`	`5416666fcb17…`
2020-06-10 20:45 UTC · source 2020-06-10	excluded package	package	40032-050-19	`9bebd1f3094a…`	`5416666fcb17…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded product	product		`110d247fa046…`	`a55b01930146…`
2019-12-08 06:16 UTC · source 2019-12-05	excluded package	package	40032-050-19	`110d247fa046…`	`a55b01930146…`

Source provenance: Browse the complete Orange Book source catalog · source snapshot 1.

Orange Book products#

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

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA		2009-05-27

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 1 matching rows.

Application-product, TE code table
Application-product	TE code
A090019-001	AA

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 · 41 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	Trade name	Strength	Dosage form / route	Product TE source text	Approval date	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL	AA	2009-05-27	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A090019-001	PEG-3350, POTASSIUM CHLORIDE, SODIUM BICARBONATE, SODIUM CHLORIDE	420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/BOT	FOR SOLUTION / ORAL		2009-05-27	`cb3db0bc1861…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-02-19 14:30 UTC	2026-02	A090019-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A090019-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A090019-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A090019-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A090019-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A090019-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A090019-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A090019-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A090019-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A090019-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A090019-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A090019-001	AA	1	`301d65b070ca…`
2019-12-13 00:20 UTC	2019-12	A090019-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A090019-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A090019-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A090019-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A090019-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A090019-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A090019-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A090019-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A090019-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A090019-001	AA	1	`ea99ee380514…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A090019-001	AA	1	`a50c72e98297…`

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
9e37788c-b1bf-42ae-aac9-b60601606144	Product name	8	20260122
95250459-30e4-45c1-b08a-993044f49109	Product name	2	20250805
d9771140-739b-484b-ae64-b79528ff1211	Product name	3	20250801
efd58dcf-540a-4531-8766-e713129ca6f2	Product name	1	20250307
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2	Product name	5	20250304
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
1527ac37-808d-43be-a63e-74e1258dbe46	Product name	9	20250219
a21a21e5-f36d-4c1f-8918-def921b8f7e3	Product name	3	20250124
bed0530e-f939-4541-956b-6928a2f6404f	Product name	1	20241008
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	6	20240814
fb7ab793-2c12-4079-b100-a64f73bef25a	Product name	4	20240712
362d7abb-94e6-4c60-9a58-266894157713	Product name	1	20231023
b0cbf770-6cc3-4aa4-9158-755110c2b9f7	Product name	2	20230717
dc7c5daa-021f-40dd-b00d-63982cb2067a	Product name	1	20230426
9fcb7a91-de07-4f00-aabf-e4d6fda403d5	Product name	8	20230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ce	Product name	2	20230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7	Product name	2	20211025
9badc7be-250a-44ab-aa36-926af3f02679	Product name	1	20210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	5	20200925
e4870509-7e28-6f92-f0be-dd3dd889a9cf	Product name	5	20200810
0ec3537a-6c9b-432a-896c-b9ea8723049a	Product name	9	20200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cd	Product name	2	20190619
444b3e50-f226-46ef-bfca-2e7035d140cd	Product name	1	20190611
816b97af-edc5-4060-aff1-b814bdbcad50	Product name	1	20190415
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
cefa60e2-a5b5-493e-9c54-24735b7dc509	Product name	2	20171212
419aab54-5d5a-4146-9453-026d4a9991be	Product name	2	20170525
26acd337-b838-40ac-bcbc-05c3b81c8712	Product name	1	20170323
08ffbcbf-26df-b99c-1dab-64fc4cfae89f	Product name	2	20160823
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831
290f523a-f9db-9774-b5a9-e1f908ac1782	Product name	1	20150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
89dac932-b90a-4410-9ab1-84c53e57de25	Product name	1	20150316
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508
5668b646-cd56-c3c7-bdea-3f6b1a8840db	Product name	1	20140508
597b1cfd-7b31-5048-62be-ca5cd740da2f	Product name	1	20140508
684ea482-2e8b-14af-5664-b98f1e402036	Product name	1	20140508
810ab97e-f109-f41c-7c83-6a652a9cbf43	Product name	1	20140508
87711080-88eb-65c5-b2dd-bf99e700a372	Product name	1	20140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2dd	Product name	1	20140508
b060cc1a-fe47-856b-0b77-4448b5963de8	Product name	1	20140508
c6b65c52-69c7-df49-550a-a50c137f6218	Product name	1	20140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840	Product name	1	20140508
ec2149b3-5c6d-5344-f757-c86411073075	Product name	1	20140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
40032-050-19	2019-10-21	C162847	48780-1	956f9ecf-c54c-621f-e053-dbdaa90a74ad	PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution with Flavor pack

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
40032-050-19	Polyethylene Glycol-3350, Sodium Chloride, Potassium Chloride and Sodium Bicarbonate	438.4 g in 1 BOTTLE	POWDER, FOR SOLUTION	438.4		2

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
POLYETHYLENE GLYCOL 3350	ACTIVE INGREDIENT	G2M7P15E5P	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
POTASSIUM CHLORIDE	ACTIVE INGREDIENT	660YQ98I10	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
SODIUM BICARBONATE	ACTIVE INGREDIENT	8MDF5V39QO	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
SODIUM CHLORIDE	ACTIVE INGREDIENT	451W47IQ8X	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
CHLORIDE ION	ACTIVE MOIETY	Q32ZN48698	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
POLYETHYLENE GLYCOL 3350	ACTIVE MOIETY	G2M7P15E5P	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
POTASSIUM CATION	ACTIVE MOIETY	295O53K152	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
SODIUM CATION	ACTIVE MOIETY	LYR4M0NH37	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
ACACIA	INACTIVE INGREDIENT	5C5403N26O	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
ALPHA-TOCOPHEROL, DL-	INACTIVE INGREDIENT	7QWA1RIO01	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
40032-050	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE POWDER, FOR SOLUTION [NOVEL LABORATORIES, INC.]	2	Legacy NDC, 1 package rows	20091119_444c83ae-ac3a-467c-be05-e2bcbfbaaba1.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 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
GAVILYTE-N	POLYETHYLENE GLYCOL-3350, SODIUM CHLORIDE, POTASSIUM CHLORIDE AND SODIUM BICARBONATE	Lupin Pharmaceuticals,Inc.	27195187-75a3-431f-90d9-84da1b94e849	2025-09-10	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 090019 application number: ANDA090019

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
801054	PEG-3350 420 GM / sodium chloride 11.2 GM / sodium bicarbonate 5.72 GM / potassium chloride 1.48 GM Powder for Oral Solution	PSN	444c83ae-ac3a-467c-be05-e2bcbfbaaba1	2
801054	polyethylene glycol 3350 420000 MG / potassium chloride 1480 MG / sodium bicarbonate 5720 MG / sodium chloride 11200 MG Powder for Oral Solution	SCD	444c83ae-ac3a-467c-be05-e2bcbfbaaba1	2
801054	PEG 3350 420 GM / potassium chloride 1.48 GM / sodium bicarbonate 5.72 GM / sodium chloride 11.2 GM per 4 L Powder for Oral Solution	SY	444c83ae-ac3a-467c-be05-e2bcbfbaaba1	2
801054	PEG-3350 420 GM / KCl 1.48 GM / NaCl 11.2 GM / NaHCO3 5.72 GM Powder for 4 L Oral Solution	SY	444c83ae-ac3a-467c-be05-e2bcbfbaaba1	2
801054	POLYETHYLENE GLYCOL 3350 420000 MG / K+ Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution	SY	444c83ae-ac3a-467c-be05-e2bcbfbaaba1	2
801054	POLYETHYLENE GLYCOL 3350 420000 MG / Pot Chloride 1480 MG / NaHCO3 5720 MG / NaCl 11200 MG Powder for Oral Solution	SY	444c83ae-ac3a-467c-be05-e2bcbfbaaba1	2

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
40032-050-19	40032005019	438.4 g in 1 BOTTLE	438.4 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PEG-3350, Sodium Chloride, Sodium Bicarbonate and Potassium Chloride for Oral Solution with Flavor pack	Novel Laboratories, Inc. \| Dow Chemical Company \| Mallinckrodt Baker Inc. \| Church and Dwight Co, Inc.	2009-05-28	HUMAN PRESCRIPTION DRUG LABEL	2