POTASSIUM CHLORIDE

Product NDC: 55154-8026
11-digit product format: 551548026
Labeler code: 55154
Product ID: 55154-8026_fea3ae21-3395-437e-b773-b180e1c98801
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: POTASSIUM CHLORIDE ORAL
Dosage form: SOLUTION
Route: ORAL
Labeler: Cardinal Health 107, LLC
Application: ANDA211648
Marketing category: ANDA
Marketing start: 2026-08-24
Substance: POTASSIUM CHLORIDE
Active strength: 1.5 g/15mL
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 · 2 matching rows.

Application-product, Trade name, Ingredient table
Application-product	Trade name	Ingredient	Strength	Dosage form / route	TE codes	RLD / RS	Approval date
A211648-001	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA		2021-05-21
A211648-002	POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA		2021-05-21

Therapeutic equivalence codes#

Current TE-code rows page 1 of 1 · 2 matching rows.

Application-product, TE code table
Application-product	TE code
A211648-001	AA
A211648-002	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 · 70 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
2026-09-14 22:38:34	2026-08	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211648-001	POTASSIUM CHLORIDE	20MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211648-002	POTASSIUM CHLORIDE	40MEQ/15ML	SOLUTION / ORAL	AA	2021-05-21	`bb7c543d1eb4…`

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 70 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	A211648-001	AA	1	`84e616aacf4f…`
2026-09-14 22:38:34	2026-08	A211648-002	AA	1	`84e616aacf4f…`
2026-08-18 06:07:40	2026-07	A211648-001	AA	1	`caaa826d4ba7…`
2026-08-18 06:07:40	2026-07	A211648-002	AA	1	`caaa826d4ba7…`
2026-02-19 14:30 UTC	2026-02	A211648-001	AA	1	`011fe1cb6892…`
2026-02-19 14:30 UTC	2026-02	A211648-002	AA	1	`011fe1cb6892…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-001	AA	1	`31067a03dcf5…`
2025-12-14 10:44 UTC · 2 captures of this ZIP	2025-12	A211648-002	AA	1	`31067a03dcf5…`
2025-08-23 18:47 UTC	2025-08	A211648-001	AA	1	`6a471c1ec25d…`
2025-08-23 18:47 UTC	2025-08	A211648-002	AA	1	`6a471c1ec25d…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-001	AA	1	`fd3edfee7708…`
2025-03-22 03:13 UTC · 3 captures of this ZIP	2025-03	A211648-002	AA	1	`fd3edfee7708…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-001	AA	1	`b8a1b40f171c…`
2025-02-26 10:13 UTC · 3 captures of this ZIP	2025-02	A211648-002	AA	1	`b8a1b40f171c…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-001	AA	1	`03ed91905a0d…`
2025-01-19 17:59 UTC · 7 captures of this ZIP	2025-01	A211648-002	AA	1	`03ed91905a0d…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-001	AA	1	`2680178bc6a6…`
2024-12-13 21:23 UTC · 2 captures of this ZIP	2024-12	A211648-002	AA	1	`2680178bc6a6…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-001	AA	1	`5bbf6a4d5a75…`
2024-09-14 05:58 UTC · 2 captures of this ZIP	2024-09	A211648-002	AA	1	`5bbf6a4d5a75…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-001	AA	1	`d8e5a09893c0…`
2024-11-08 22:44 UTC · 3 captures of this ZIP	2024-11	A211648-002	AA	1	`d8e5a09893c0…`
2024-10-29 15:01 UTC	2024-10	A211648-001	AA	1	`d06236e962d9…`
2024-10-29 15:01 UTC	2024-10	A211648-002	AA	1	`d06236e962d9…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-001	AA	1	`79d66fd596c7…`
2024-08-13 05:28 UTC · 3 captures of this ZIP	2024-08	A211648-002	AA	1	`79d66fd596c7…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-001	AA	1	`301d65b070ca…`
2024-07-13 05:37 UTC · 2 captures of this ZIP	2024-07	A211648-002	AA	1	`301d65b070ca…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-001	AA	1	`1e350fbaab3a…`
2024-06-18 03:08 UTC · 5 captures of this ZIP	2024-06	A211648-002	AA	1	`1e350fbaab3a…`
2024-05-31 18:47 UTC	2024-05	A211648-001	AA	1	`8072bd15b7f6…`
2024-05-31 18:47 UTC	2024-05	A211648-002	AA	1	`8072bd15b7f6…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-001	AA	1	`5c6f7cd8ea54…`
2022-06-29 02:47 UTC · 2 captures of this ZIP	2022-06	A211648-002	AA	1	`5c6f7cd8ea54…`
2022-04-08 23:34 UTC	2022-04	A211648-001	AA	1	`5d02ea3f76ae…`
2022-04-08 23:34 UTC	2022-04	A211648-002	AA	1	`5d02ea3f76ae…`
2022-04-04 05:41 UTC	2022-04	A211648-001	AA	1	`4b0b4de00fa7…`
2022-04-04 05:41 UTC	2022-04	A211648-002	AA	1	`4b0b4de00fa7…`
2022-03-09 01:35 UTC	2022-03	A211648-001	AA	1	`bb7c543d1eb4…`
2022-03-09 01:35 UTC	2022-03	A211648-002	AA	1	`bb7c543d1eb4…`

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/15mL

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
312515	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
fea3ae21-3395-437e-b773-b180e1c98801	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 · 4 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	Cardinal Health 107, LLC	fea3ae21-3395-437e-b773-b180e1c98801	2026-08-24	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648 ndc (product): 55154-8026
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE ORAL	ATLANTIC BIOLOGICALS CORP.	dc55474c-cc51-4f17-8cb3-0f34b3e68a55	2025-12-11	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	American Health Packaging	7956883f-0d31-4081-bbea-d9ea320a193b	2025-08-04	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648
POTASSIUM CHLORIDE	POTASSIUM CHLORIDE	Kesin Pharma Corporation	25c2b417-eeea-4ba6-8eb9-a7d8a08c6093	2024-03-12	Warnings, Adverse reactions	Exact identifier application applno (ANDA): 211648 application number: ANDA211648

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	Marketing start	Sample	Exclude flag	Status
55154-8026-5	55154802605	5 CUP, UNIT-DOSE in 1 BAG (55154-8026-5) / 15 mL in 1 CUP, UNIT-DOSE	2026-08-24	No	No	Current