FDA.reportPublic FDA data

Potassium Chloride

Product NDC
71085-083
11-digit product format
710850083
Labeler code
71085
Product ID
71085-083_0f19da2c-a9ab-44fe-a38b-acb56c1c1883
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
Potassium Chloride
Dosage form
FOR SOLUTION
Route
ORAL
Labeler
IPG Pharmaceuticals, Inc.
Application
NDA208019
Marketing category
NDA
Marketing start
2025-12-01
Marketing end
2028-11-30
Substance
POTASSIUM CHLORIDE
Active strength
3 g/3.16g
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
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 · 4 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N208019-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19
N208019-002POKONZAPOTASSIUM CHLORIDE10MEQFOR SOLUTION / ORALRLD2023-08-25
N208019-003POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25
N208019-004POKONZAPOTASSIUM CHLORIDE15MEQFOR SOLUTION / ORALRLD2025-11-12

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N208019-001AA

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 3 · 90 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1984e616aacf4f…
2026-09-14 22:38:342026-08N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-2584e616aacf4f…
2026-09-14 22:38:342026-08N208019-004POKONZA15MEQFOR SOLUTION / ORALRLD2025-11-1284e616aacf4f…
2026-08-18 06:07:402026-07N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19caaa826d4ba7…
2026-08-18 06:07:402026-07N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25caaa826d4ba7…
2026-08-18 06:07:402026-07N208019-004POKONZA15MEQFOR SOLUTION / ORALRLD2025-11-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25011fe1cb6892…
2026-02-19 14:30 UTC2026-02N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1931067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2531067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD, RS2015-08-196a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-256a471c1ec25d…
2025-08-23 18:47 UTC2025-08N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-256a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD, RS2015-08-19fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD, RS2015-08-19b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD2023-08-25b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1903ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2503ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-2503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-192680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-252680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-252680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-195bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-255bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-255bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-19d06236e962d9…
2024-10-29 15:01 UTC2024-10N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-25d06236e962d9…
2024-10-29 15:01 UTC2024-10N208019-003POTASSIUM CHLORIDE40MEQFOR SOLUTION / ORALRLD, RS2023-08-25d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208019-001POTASSIUM CHLORIDE20MEQFOR SOLUTION / ORALAARLD2015-08-1979d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N208019-002POKONZA10MEQFOR SOLUTION / ORALRLD2023-08-2579d66fd596c7…

Observed Orange Book normalized TE history#

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

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2022-09-29 23:25 UTC2022-09N208019-001AA1e64feba35796…
2022-07-09 03:26 UTC · 3 captures of this ZIP2022-07N208019-001AA1cb3db0bc1861…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N208019-001AA1a50c72e98297…

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

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE3 g/3.16g

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
95250459-30e4-45c1-b08a-993044f49109Product name220250805
d9771140-739b-484b-ae64-b79528ff1211Product name320250801
efd58dcf-540a-4531-8766-e713129ca6f2Product name120250307
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
bed0530e-f939-4541-956b-6928a2f6404fProduct name120241008
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71085-083-01Potassium Chloride3.16 g in 1 POUCHFOR SOLUTION3.161
71085-083-30Potassium Chloride30 in 1 CARTONFOR SOLUTION301

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71085-083-01EA - Each71085-083ef3a2316-8641-4eb4-ac0b-0790fdfba21b12026-01-08
71085-083-30EA - Each71085-083ebe4794c-6d2e-48e0-b499-e432cf73897012026-01-08

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC0700c19e-abca-4527-8944-e4440a32e3af2025-12-18Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
Potassium ChloridePOTASSIUM CHLORIDEEndo USA, Inc.a64d7151-09a6-474c-83fc-36c7cf582d322025-03-26Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
POKONZAPOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC7c5cc705-e5da-4487-86c9-9d545a95afb42024-03-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences Inc.23d818e7-c076-40de-8dc1-0b51ba4be96a2020-04-28Warnings, Adverse reactionsExact identifier
application applno (NDA): 208019
application number: NDA208019

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2728724potassium chloride 40 MEQ (3 GM) Powder for Oral SolutionPSN5dad0879-0f97-4c7d-98fa-baaed51cd2d81
2728724potassium chloride 40 MEQ Powder for Oral SolutionSCD5dad0879-0f97-4c7d-98fa-baaed51cd2d81
2728724K+ chloride 40 MEQ Powder for Oral SolutionSY5dad0879-0f97-4c7d-98fa-baaed51cd2d81
2728724Pot chloride 40 MEQ Powder for Oral SolutionSY5dad0879-0f97-4c7d-98fa-baaed51cd2d81
2728724potassium chloride 3 GM Powder for Oral SolutionSY5dad0879-0f97-4c7d-98fa-baaed51cd2d81

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
71085-083-01710850083013.16 g in 1 POUCH3.16 gHistorical
71085-083-307108500833030 POUCH in 1 CARTON (71085-083-30) / 3.16 g in 1 POUCH (71085-083-01) 30 pouch2025-12-012028-11-30NoNoHistorical