Potassium Chloride

Product NDC: 55154-8352
Requested package NDC: 55154-8352-5
11-digit product format: 551548352
Labeler code: 55154
Product ID: 55154-8352_ea55ded1-e076-43de-ad3c-c75e7d0a4ebc
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Potassium Chloride
Dosage form: POWDER, FOR SOLUTION
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA214108
Marketing category: ANDA
Marketing start: 2026-08-24
Substance: POTASSIUM CHLORIDE
Active strength: 1.5 g/1.58g
Pharmacologic classes: Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Osmotic Activity [MoA], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC]
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
A214108-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA		2022-03-24

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-product	TE code
A214108-001	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	Approval date	Source SHA-256
2026-09-14 22:38:34	2026-08	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214108-001	POTASSIUM CHLORIDE	20MEQ	FOR SOLUTION / ORAL	AA	2022-03-24	`a50c72e98297…`

Observed Orange Book normalized TE history#

Captured, Edition, Application-product table
Captured	Edition	Application-product	TE code	Order	Source SHA-256
2026-09-14 22:38:34	2026-08	A214108-001	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A214108-001	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A214108-001	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A214108-001	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A214108-001	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A214108-001	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A214108-001	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A214108-001	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A214108-001	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A214108-001	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A214108-001	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A214108-001	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A214108-001	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A214108-001	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A214108-001	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A214108-001	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A214108-001	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A214108-001	AA	1	`5d02ea3f76ae…`
2024-03-16 18:09 UTC · 4 captures of this ZIP	2024-03	A214108-001	AA	1	`6a51e52b5d6a…`
2024-02-18 07:12 UTC	2024-02	A214108-001	AA	1	`1c564ffb4f44…`
2023-12-20 04:57 UTC	2023-12	A214108-001	AA	1	`ea1830bbd6c7…`
2023-11-28 05:40 UTC · 2 captures of this ZIP	2023-11	A214108-001	AA	1	`a72a2bbeb626…`
2023-10-25 00:34 UTC · 2 captures of this ZIP	2023-10	A214108-001	AA	1	`9b2671bbb829…`
2023-07-15 15:27 UTC · 2 captures of this ZIP	2023-07	A214108-001	AA	1	`a67488948f0b…`
2023-06-13 01:57 UTC · 3 captures of this ZIP	2023-06	A214108-001	AA	1	`3f0d92c62455…`
2023-05-13 08:27 UTC	2023-05	A214108-001	AA	1	`053a50430f4f…`
2023-01-26 05:58 UTC	2023-01	A214108-001	AA	1	`3bdfa0b2c4d7…`
2022-11-12 20:34 UTC · 5 captures of this ZIP	2022-11	A214108-001	AA	1	`3a93d1ddd44b…`
2022-10-28 04:53 UTC	2022-10	A214108-001	AA	1	`f41ea6bd6efb…`
2022-09-29 23:25 UTC	2022-09	A214108-001	AA	1	`e64feba35796…`
2022-07-09 03:26 UTC · 3 captures of this ZIP	2022-07	A214108-001	AA	1	`cb3db0bc1861…`
2026-07-26 02:55 UTC · 3 captures of this ZIP	2026-06	A214108-001	AA	1	`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: Potassium Chloride
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
POTASSIUM CHLORIDE	1.5 g/1.58g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
660YQ98I10	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1867544	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
ea55ded1-e076-43de-ad3c-c75e7d0a4ebc	Available on FDA.report

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 · 3 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Potassium Chloride	POTASSIUM CHLORIDE	Cardinal Health 107, LLC	ea55ded1-e076-43de-ad3c-c75e7d0a4ebc	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214108 application number: ANDA214108 ndc (package): 55154-8352-5 ndc (product): 55154-8352 ndc11 (package): 55154835205
Potassium Chloride	POTASSIUM CHLORIDE	Advagen Pharma Limited	d528c0c1-b81f-4f7a-8518-e6911b23c3eb	2026-01-13	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214108 application number: ANDA214108
Potassium Chloride	POTASSIUM CHLORIDE	Northstar Rx LLC	fbed8c29-b3f1-4e53-b290-6f717290cecf	2025-10-07	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 214108 application number: ANDA214108

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
660YQ98I10	POTASSIUM CHLORIDE	7447-40-7	POTASSIUM CHLORIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
55154-8352-5	55154835205	5 POUCH in 1 BAG (55154-8352-5) / 1.58 g in 1 POUCH	5 pouch	2026-08-24	No	No	Current