GoLYTELY

Product NDC: 52268-101
Requested package NDC: 52268-101-01
11-digit product format: 522680101
Labeler code: 52268
Product ID: 52268-101_c3649858-77b7-2295-e053-2995a90a048f
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Polyethylene Glycol 3350, Sodium Sulfate Anhydrous, Sodium Bicarbonate, Sodium Chloride, Potassium Chloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Braintree Laboratories, Inc.
Application: NDA019011
Marketing category: NDA
Marketing start: 1984-07-13
Marketing end: 2022-10-31
Substance: POLYETHYLENE GLYCOL 3350; SODIUM SULFATE ANHYDROUS; SODIUM BICARBONATE; SODIUM CHLORIDE; POTASSIUM CHLORIDE
Active strength: 236 g/4L; g/4L; g/4L; g/4L; g/4L
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],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],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: No
Listing certified through: 0000-00-00
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status. Browse every current auxiliary row, including rows without a usable NDC. · Browse every captured source and parsed snapshot.

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

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	52268-101	52268-101-01	D	Discontinued by firm		2026-07-31

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
N019011-001	GOLYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13
N019011-002	GOLYTELY	POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE ANHYDROUS	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N019011-001	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.

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
2026-08-01 22:54:32	2026-06	N019011-001	GOLYTELY	236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/BOT;22.74GM/BOT	FOR SOLUTION / ORAL	AA	RLD, RS	1984-07-13	`a50c72e98297…`
2026-08-01 22:54:32	2026-06	N019011-002	GOLYTELY	227.1GM/PACKET;2.82GM/PACKET;6.36GM/PACKET;5.53GM/PACKET;21.5GM/PACKET	FOR SOLUTION / ORAL		RLD	1992-06-02	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-01 22:54:32	2026-06	N019011-001	AA	1	`a50c72e98297…`

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 1 · 6 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	19daf830-7270-4661-81b1-ded38f867f28	2026-07-24	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG 3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Wilshire Pharmaceuticals, Inc.	b251752d-7750-482a-9364-0acf4ad47cc8	2026-04-16	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Azurity Pharmaceuticals, Inc.	7609ecf7-0ce0-4fbb-9c27-30987f689575	2026-04-15	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	A-S Medication Solutions	7a2d8dab-750f-43c1-933c-4169a840c60c	2023-06-20	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
PEG-3350 and Electrolytes	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Affordable Pharmaceuticals, LLC	448db7a5-1fea-4bf3-b1f5-e9d027a36603	2022-09-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011
GoLYTELY	POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE	Braintree Laboratories, Inc.	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	2021-05-28	Warnings, Adverse reactions	Exact identifier application applno (NDA): 019011 application number: NDA019011 ndc (package): 52268-101-01 ndc (product): 52268-101 ndc11 (package): 52268010101

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
52268-101-01	GoLYTELY	4 L in 1 BOTTLE, PLASTIC	POWDER, FOR SOLUTION	4		5

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
52268-101-01	ML - Milliliter	52268-101	f56d6035-c2af-4c1c-ba8e-86671021f8f0	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Polyethylene Glycol 3350	ACTIVE INGREDIENT	G2M7P15E5P	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Potassium Chloride	ACTIVE INGREDIENT	660YQ98I10	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Sodium Bicarbonate	ACTIVE INGREDIENT	8MDF5V39QO	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Sodium Chloride	ACTIVE INGREDIENT	451W47IQ8X	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Sodium Sulfate Anhydrous	ACTIVE INGREDIENT	36KCS0R750	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Bicarbonate Ion	ACTIVE MOIETY	HN1ZRA3Q20	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Chloride Ion	ACTIVE MOIETY	Q32ZN48698	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Polyethylene Glycol 3350	ACTIVE MOIETY	G2M7P15E5P	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2
Sulfate Ion	ACTIVE MOIETY	7IS9N8KPMG	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
52268-101	GOLYTELY (POLYETHYLENE GLYCOL 3350, SODIUM SULFATE ANHYDROUS, SODIUM BICARBONATE, SODIUM CHLORIDE, POTASSIUM CHLORIDE) POWDER, FOR SOLUTION [BRAINTREE LABORATORIES, INC.]	5	Legacy NDC, 1 package rows	20210529_57d22b0b-1ae0-4203-babc-f3bac17bd1c9.zip

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
G2M7P15E5P	POLYETHYLENE GLYCOL 3350	25322-68-3	POLYETHYLENE GLYCOL 3350
36KCS0R750	SODIUM SULFATE ANHYDROUS	7757-82-6	SODIUM SULFATE ANHYDROUS
8MDF5V39QO	SODIUM BICARBONATE	144-55-8	SODIUM BICARBONATE
451W47IQ8X	SODIUM CHLORIDE	7647-14-5	SODIUM CHLORIDE
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
966916	GoLYTELY Packet Powder for Oral Solution	PSN	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966922	GoLYTELY Plastic Bottle Powder for Oral Solution	PSN	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
1870431	polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM Powder for Oral Solution	PSN	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966920	polyethylene glycol 3350 236 GM / potassium chloride 2.97 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 22.74 GM Powder for Oral Solution	PSN	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966916	polyethylene glycol 3350 227100 MG / potassium chloride 2820 MG / sodium bicarbonate 6360 MG / sodium chloride 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution [Golytely]	SBD	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966922	polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Golytely]	SBD	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
1870431	polyethylene glycol 3350 227100 MG / potassium chloride 2820 MG / sodium bicarbonate 6360 MG / sodium chloride 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution	SCD	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966920	polyethylene glycol 3350 236000 MG / potassium chloride 2970 MG / sodium bicarbonate 6740 MG / sodium chloride 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution	SCD	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966916	Golytely (polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM) Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966922	Golytely (polyethylene glycol 3350 236 GM / potassium chloride 2.97 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 22.74 GM) Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
1870431	polyethylene glycol 3350 227.1 GM / potassium chloride 2.82 GM / sodium bicarbonate 6.36 GM / sodium chloride 5.53 GM / sodium sulfate 21.5 GM Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
1870431	POLYETHYLENE GLYCOL 3350 227100 MG / K+ Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966916	POLYETHYLENE GLYCOL 3350 227100 MG / K+ Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution [Golytely]	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
1870431	POLYETHYLENE GLYCOL 3350 227100 MG / Pot Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966916	POLYETHYLENE GLYCOL 3350 227100 MG / Pot Chloride 2820 MG / NaHCO3 6360 MG / NaCl 5530 MG / sodium sulfate 21500 MG Powder for Oral Solution [Golytely]	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966920	polyethylene glycol 3350 236 GM / potassium chloride 2.97 GM / sodium bicarbonate 6.74 GM / sodium chloride 5.86 GM / sodium sulfate 22.74 GM Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966920	POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966922	POLYETHYLENE GLYCOL 3350 236000 MG / K+ Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Golytely]	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966920	POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5
966922	POLYETHYLENE GLYCOL 3350 236000 MG / Pot Chloride 2970 MG / NaHCO3 6740 MG / NaCl 5860 MG / sodium sulfate 22740 MG Powder for Oral Solution [Golytely]	SY	57d22b0b-1ae0-4203-babc-f3bac17bd1c9	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
52268-101-01	52268010101	4 L in 1 BOTTLE, PLASTIC (52268-101-01)	4 l	1984-07-13	2022-10-31	No	No	Current