SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE

Product NDC: 52536-177
Requested package NDC: 52536-177-01
11-digit product format: 525360177
Labeler code: 52536
Product ID: 52536-177_f269929e-c2ff-4288-9d3b-7770bcb5a498
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium sulfate, potassium sulfate, magnesium sulfate
Dosage form: SOLUTION, CONCENTRATE
Route: ORAL
Labeler: Wilshire Pharmaceuticals, Inc.
Application: NDA022372
Marketing category: NDA
Marketing start: 2026-04-15
Substance: SODIUM SULFATE; POTASSIUM SULFATE; MAGNESIUM SULFATE, UNSPECIFIED FORM
Active strength: 13.13; 2.35; 1.2 g/133.1mL; g/133.1mL; g/133.1mL
Pharmacologic classes: Calculi Dissolution Agent [EPC], 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], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], 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: 2027-12-31
Current FDA listing: Yes

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

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
N022372-001	SUPREP BOWEL PREP KIT	MAGNESIUM SULFATE; POTASSIUM SULFATE; SODIUM SULFATE	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
N022372-001	AA

Orange Book exclusivity#

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

Application-product, Exclusivity code, Expiration table
Application-product	Exclusivity code	Expiration
N022372-001	ODE-315	2027-08-05

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 · 43 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
2026-09-14 22:38:34	2026-08	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022372-001	SUPREP BOWEL PREP KIT	1.6GM/BOT;3.13GM/BOT;17.5GM/BOT	SOLUTION / ORAL	AA	RLD, RS	2010-08-05	`f41ea6bd6efb…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	N022372-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022372-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022372-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022372-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022372-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022372-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022372-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022372-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022372-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022372-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022372-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022372-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022372-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022372-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022372-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022372-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	AA	1	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022372-001	AA	1	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022372-001	AA	1	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	AA	1	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	AA	1	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	AA	1	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022372-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022372-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022372-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022372-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022372-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022372-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022372-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022372-001	AA	1	`f41ea6bd6efb…`

Observed Orange Book patent history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Patent	Expiration	Use code	Coverage / status	Source SHA-256
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	6946149	2023-03-07	U-837	Drug product	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	6946149	2023-03-07	U-837	Drug product	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	6946149	2023-03-07	U-837	Drug product	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	N022372-001	6946149	2023-03-07	U-837	Drug product	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	N022372-001	6946149	2023-03-07	U-837	Drug product	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	6946149	2023-03-07	U-837	Drug product	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	6946149	2023-03-07	U-837	Drug product	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	6946149	2023-03-07	U-837	Drug product	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	6946149	2023-03-07	U-837	Drug product	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	N022372-001	6946149	2023-03-07	U-837	Drug product	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	N022372-001	6946149	2023-03-07	U-837	Drug product	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	N022372-001	6946149	2023-03-07	U-837	Drug product	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	N022372-001	6946149	2023-03-07	U-837	Drug product	`ea99ee380514…`
2023-12-20 04:57 UTC	2023-12	N022372-001	6946149	2023-03-07	U-837	Drug product	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	6946149	2023-03-07	U-837	Drug product	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	6946149	2023-03-07	U-837	Drug product	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	6946149	2023-03-07	U-837	Drug product	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	6946149	2023-03-07	U-837	Drug product	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	6946149	2023-03-07	U-837	Drug product	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	6946149	2023-03-07	U-837	Drug product	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	6946149	2023-03-07	U-837	Drug product	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022372-001	6946149	2023-03-07	U-837	Drug product	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022372-001	6946149	2023-03-07	U-837	Drug product	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022372-001	6946149	2023-03-07	U-837	Drug product	`cb3db0bc1861…`

Observed Orange Book exclusivity history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	Exclusivity code	Expiration	Source SHA-256
2026-09-14 22:38:34	2026-08	N022372-001	ODE-315	2027-08-05	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	N022372-001	ODE-315	2027-08-05	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	N022372-001	ODE-315	2027-08-05	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	N022372-001	ODE-315	2027-08-05	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	N022372-001	ODE-315	2027-08-05	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	N022372-001	ODE-315	2027-08-05	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	N022372-001	ODE-315	2027-08-05	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	N022372-001	ODE-315	2027-08-05	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	N022372-001	ODE-315	2027-08-05	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	N022372-001	ODE-315	2027-08-05	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	N022372-001	ODE-315	2027-08-05	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	N022372-001	ODE-315	2027-08-05	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	N022372-001	ODE-315	2027-08-05	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	N022372-001	ODE-315	2027-08-05	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	N022372-001	ODE-315	2027-08-05	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	N022372-001	ODE-315	2027-08-05	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	N022372-001	ODE-315	2027-08-05	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	N022372-001	ODE-315	2027-08-05	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	N022372-001	ODE-315	2027-08-05	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	N022372-001	ODE-315	2027-08-05	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	N022372-001	ODE-315	2027-08-05	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	N022372-001	ODE-315	2027-08-05	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	N022372-001	ODE-315	2027-08-05	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	N022372-001	ODE-315	2027-08-05	`8869cabd3fbd…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	N022372-001	ODE-315	2027-08-05	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	N022372-001	ODE-315	2027-08-05	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	N022372-001	ODE-315	2027-08-05	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	N022372-001	ODE-315	2027-08-05	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	N022372-001	ODE-315	2027-08-05	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	N022372-001	ODE-315	2027-08-05	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	N022372-001	ODE-315	2027-08-05	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	N022372-001	ODE-315	2027-08-05	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	N022372-001	ODE-315	2027-08-05	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	N022372-001	ODE-315	2027-08-05	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	N022372-001	ODE-315	2027-08-05	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	N022372-001	ODE-315	2027-08-05	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	N022372-001	ODE-315	2027-08-05	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	N022372-001	ODE-315	2027-08-05	`a50c72e98297…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM SULFATE	13.13 g/133.1mL
POTASSIUM SULFATE	2.35 g/133.1mL
MAGNESIUM SULFATE, UNSPECIFIED FORM	1.2 g/133.1mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K573LC5TV	Internal UNII lookup
DE08037SAB	Internal UNII lookup
0YPR65R21J	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 3 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1001689	Internal RxNorm lookup
1120068	Internal RxNorm lookup
2390767	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
f269929e-c2ff-4288-9d3b-7770bcb5a498	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
6e3c022f-0786-43f1-8857-edff89d5153f	Product name	1	20260309
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
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
efd58652-cb8f-4018-91ca-4b0eb2ff729f	Product name	7	20240226
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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6	Product name	1	20230320
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
2641ccb3-721d-4fbf-9f2f-ca2f18157a62	Product name	3	20210309
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
11ed6f83-cdd2-4637-8379-b1a1d3ae3cde	Product name	1	20181101
7cda52fc-125f-421c-8fea-bc1974370c49	Product name	2	20180703
7916de40-e296-41f0-b811-6d0df1a33e2c	Product name	9	20180627
86c45a79-b9f0-4476-a27c-6e10db098497	Product name	1	20180125
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
e7e58cd3-cacb-49df-8d34-1ee335614abb	Product name	1	20150609
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
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
52536-177-01	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	2 in 1 CARTON	SOLUTION, CONCENTRATE	2		1
52536-177-01	SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	133.1 mL in 1 BOTTLE, PLASTIC	SOLUTION, CONCENTRATE	133.1		1

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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE	Wilshire Pharmaceuticals, Inc.	f269929e-c2ff-4288-9d3b-7770bcb5a498	2026-04-13	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022372 application number: NDA022372 ndc (package): 52536-177-01 ndc (product): 52536-177 ndc11 (package): 52536017701
SUPREP Bowel Prep	SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE	Azurity Pharmaceuticals, Inc.	50f23abd-6a66-44cb-960e-d43c16a5ae5f	2026-01-31	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022372 application number: NDA022372
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE	Affordable Pharmaceuticals, LLC	f86bdcc8-e643-4160-89ae-01c89bee842d	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022372 application number: NDA022372
SUPREP Bowel Prep	SODIUM SULFATE, POTASSIUM SULFATE, MAGNESIUM SULFATE	Braintree Laboratories, Inc.	2f5f06de-ee98-44c0-be7e-9a998d1e5c16	2025-11-30	Warnings, Adverse reactions	Exact identifier application applno (NDA): 022372 application number: NDA022372

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
0YPR65R21J	SODIUM SULFATE	7727-73-3	SODIUM SULFATE
1K573LC5TV	POTASSIUM SULFATE	7778-80-5	POTASSIUM SULFATE
DE08037SAB	MAGNESIUM SULFATE, UNSPECIFIED FORM		MAGNESIUM SULFATE, UNSPECIFIED FORM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
2390767	{2 (355 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack	GPCK	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1001689	{2 (480 ML) (magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution) } Pack	GPCK	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
2390767	{2 (12 OZ magnesium sulfate 1.2 GM / potassium sulfate 2.35 GM / sodium sulfate 13.13 GM Oral Solution) } Pack	PSN	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1001689	2 (16 OZ magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM Oral Solution) Pack	PSN	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1120068	magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM in 177 mL Oral Solution	PSN	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1120068	magnesium sulfate 0.0277 MEQ/ML / potassium sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution	SCD	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1120068	Magnesium Sulfate 0.0277 MEQ/ML / K+ sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution	SY	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1120068	Magnesium Sulfate 0.0277 MEQ/ML / Pot sulfate 0.0374 MEQ/ML / sodium sulfate 0.257 MEQ/ML Oral Solution	SY	f269929e-c2ff-4288-9d3b-7770bcb5a498	1
1120068	magnesium sulfate 1.6 GM / potassium sulfate 3.13 GM / sodium sulfate 17.5 GM per 177 ML Oral Solution	SY	f269929e-c2ff-4288-9d3b-7770bcb5a498	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Sample	Exclude flag	Status
52536-177-01	52536017701	2 BOTTLE, PLASTIC in 1 CARTON (52536-177-01) / 133.1 mL in 1 BOTTLE, PLASTIC	2026-04-15	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SODIUM SULFATE, POTASSIUM SULFATE AND MAGNESIUM SULFATE	Wilshire Pharmaceuticals, Inc.	2026-04-13	Human Prescription Drug Label	1