Sodium Polystyrene Sulfonate

Product NDC: 55154-7353
11-digit product format: 551547353
Labeler code: 55154
Product ID: 55154-7353_f1158403-506e-4083-82b8-a0ef7dc757d5
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: sodium polystyrene sulfonate
Dosage form: SUSPENSION
Route: ORAL; RECTAL
Labeler: Cardinal Health 107, LLC
Application: ANDA087859
Marketing category: ANDA
Marketing start: 1983-01-01
Substance: SODIUM POLYSTYRENE SULFONATE
Active strength: 15 g/60mL
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 42.

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
A087859-001	SPS	SODIUM POLYSTYRENE SULFONATE	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A087859-001	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 · 42 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
2026-08-18 06:07:40	2026-07	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL		RLD, RS	1982-12-08	`4b0b4de00fa7…`
2019-12-13 00:20 UTC	2019-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RS	1982-12-08	`74a2ff9319b5…`
2022-03-09 01:35 UTC	2022-03	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL		RLD, RS	1982-12-08	`bb7c543d1eb4…`
2021-12-28 21:50 UTC	2021-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL		RLD, RS	1982-12-08	`782e0a99824c…`
2021-05-05 16:15 UTC · 3 captures of this ZIP	2021-05	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL		RS	1982-12-08	`87673890dc5c…`
2021-03-12 10:30 UTC	2021-03	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL		RS	1982-12-08	`5aa47cf7b7d7…`
2020-12-22 03:56 UTC	2020-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RS	1982-12-08	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RS	1982-12-08	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RS	1982-12-08	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RS	1982-12-08	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RS	1982-12-08	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087859-001	SPS	15GM/60ML	SUSPENSION / ORAL, RECTAL	AA	RLD, RS	1982-12-08	`e64feba35796…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-08-18 06:07:40	2026-07	A087859-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A087859-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A087859-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A087859-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A087859-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A087859-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A087859-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A087859-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A087859-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A087859-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A087859-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A087859-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A087859-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A087859-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A087859-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A087859-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A087859-001	AA	1	`5d02ea3f76ae…`
2019-12-13 00:20 UTC	2019-12	A087859-001	AA	1	`74a2ff9319b5…`
2020-12-22 03:56 UTC	2020-12	A087859-001	AA	1	`8869cabd3fbd…`
2020-11-12 02:37 UTC	2020-11	A087859-001	AA	1	`c0c555d07b60…`
2019-12-14 00:12 UTC	2019-12	A087859-001	AA	1	`3f01610625f2…`
2019-09-15 20:21 UTC	2019-09	A087859-001	AA	1	`b00525d2431f…`
2019-07-19 19:46 UTC	2019-07	A087859-001	AA	1	`ea99ee380514…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A087859-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A087859-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A087859-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A087859-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A087859-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A087859-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A087859-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A087859-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A087859-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A087859-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A087859-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A087859-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A087859-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A087859-001	AA	1	`a50c72e98297…`

Additional Listing Data#

Finished product: Yes
Brand name base: Sodium Polystyrene Sulfonate
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
SODIUM POLYSTYRENE SULFONATE	15 g/60mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1699G8679Z	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
313072	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
3c3b02a3-9a75-40a5-889d-97318faf881f	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
a90f088a-9578-47a2-8f6e-0a9d32aafec6	Product name	1	20181030
f6c90bdc-1674-455a-aadd-1b1b59e5edeb	Product name	2	20181030
f1ec5c2f-d01e-a277-5826-c7eba86ed99b	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
55154-7353-2	Sodium Polystyrene Sulfonate	2 in 1 BAG	SUSPENSION	2		10
55154-7353-2	Sodium Polystyrene Sulfonate	60 mL in 1 BOTTLE, UNIT-DOSE	SUSPENSION	60		10

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
55154-7353-2	ML - Milliliter	55154-7353	87dfee85-8e29-4ea6-af46-2efb5f189685	1	2019-05-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
SODIUM POLYSTYRENE SULFONATE	ACTIVE INGREDIENT	1699G8679Z	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
POLYSTYRENE SULFONIC ACID	ACTIVE MOIETY	70KO0R01RY	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
MAGNESIUM ALUMINUM SILICATE	INACTIVE INGREDIENT	6M3P64V0NC	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
SACCHARIN SODIUM	INACTIVE INGREDIENT	SB8ZUX40TY	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
SORBITOL	INACTIVE INGREDIENT	506T60A25R	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
55154-7353	SODIUM POLYSTYRENE SULFONATE SUSPENSION [CARDINAL HEALTH 107, LLC]	9	Current NDC, Legacy NDC, 2 package rows	20240214_3c3b02a3-9a75-40a5-889d-97318faf881f.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
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	Cardinal Health 107, LLC	3c3b02a3-9a75-40a5-889d-97318faf881f	2025-10-29	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087859 application number: ANDA087859 ndc (product): 55154-7353
Sodium Polystyrene Sulfonate	SODIUM POLYSTYRENE SULFONATE	CMP Pharma, Inc.	12d48dcf-07bd-4b06-bd6c-7543f1be8357	2021-08-15	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 087859 application number: ANDA087859

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1699G8679Z	SODIUM POLYSTYRENE SULFONATE	9080-79-9	SODIUM POLYSTYRENE SULFONATE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
313072	sodium polystyrene sulfonate 15 GM in 60 mL Oral or Rectal Suspension	PSN	3c3b02a3-9a75-40a5-889d-97318faf881f	10
313072	sodium polystyrene sulfonate 250 MG/ML Oral Suspension	SCD	3c3b02a3-9a75-40a5-889d-97318faf881f	10
313072	sodium polystyrene sulfonate 15 GM per 60 ML Oral Suspension	SY	3c3b02a3-9a75-40a5-889d-97318faf881f	10
313072	sodium polystyrene sulfonate 30 GM per 120 ML Oral Suspension	SY	3c3b02a3-9a75-40a5-889d-97318faf881f	10

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Marketing start	Marketing end	Sample	Exclude flag	Status
55154-7353-2	55154735302	2 BOTTLE, UNIT-DOSE in 1 BAG (55154-7353-2) / 60 mL in 1 BOTTLE, UNIT-DOSE	1983-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
SPS ® SUSPENSION Sodium Polystyrene Sulfonate Suspension, USP	Cardinal Health 107, LLC	2025-10-29	HUMAN PRESCRIPTION DRUG LABEL	10