FDA.reportPublic FDA data

POKONZA potassium chloride

Product NDC
15370-307
11-digit product format
153700307
Labeler code
15370
Product ID
15370-307_63d621b7-ee4e-4230-be7e-f186ea90fe11
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
potassium chloride
Dosage form
LIQUID
Route
ORAL
Labeler
Carwin Pharmaceutical Associates, LLC
Application
NDA206814
Marketing category
NDA
Marketing start
2026-01-14
Substance
POTASSIUM CHLORIDE
Active strength
10 meq/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 42.

Orange Book products#

Current product rows page 1 of 1 · 3 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N206814-001POTASSIUM CHLORIDEPOTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22
N206814-002POTASSIUM CHLORIDEPOTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22
N206814-003POKONZAPOTASSIUM CHLORIDE10MEQ/15MLSOLUTION / ORALRLD2025-11-25

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N206814-001AA
N206814-002AA

Orange Book patents#

Current patent rows page 1 of 1 · 2 matching rows.

Application-product, Patent, Expiration table
Application-productPatentExpirationUse codeCoverage / statusSubmission date
N206814-001125393142039-03-07Drug product2026-02-04
N206814-002125393142039-03-07Drug product2026-02-04

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 · 88 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-08-18 06:07:402026-07N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-003POKONZA10MEQ/15MLSOLUTION / ORALRLD2025-11-25caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-003POKONZA10MEQ/15MLSOLUTION / ORALRLD2025-11-25011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-2231067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-003POKONZA10MEQ/15MLSOLUTION / ORALRLD2025-11-2531067a03dcf5…
2025-08-23 18:47 UTC2025-08N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-226a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-226a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2203ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-2203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-222680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-222680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-225bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-225bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22d06236e962d9…
2024-10-29 15:01 UTC2024-10N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2279d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-2279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-22301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-22301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-221e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-221e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-228072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-228072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-225c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-225c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-225d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-225d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-224b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206814-002POTASSIUM CHLORIDE40MEQ/15MLSOLUTION / ORALAARLD, RS2014-12-224b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206814-001POTASSIUM CHLORIDE20MEQ/15MLSOLUTION / ORALAARLD2014-12-2274a2ff9319b5…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 3 · 84 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-08-18 06:07:402026-07N206814-001AA1caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-002AA1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206814-001AA1011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-002AA1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-001AA131067a03dcf5…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N206814-002AA131067a03dcf5…
2025-08-23 18:47 UTC2025-08N206814-001AA16a471c1ec25d…
2025-08-23 18:47 UTC2025-08N206814-002AA16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-001AA1fd3edfee7708…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N206814-002AA1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-001AA1b8a1b40f171c…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N206814-002AA1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-001AA103ed91905a0d…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N206814-002AA103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-001AA12680178bc6a6…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N206814-002AA12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-001AA15bbf6a4d5a75…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N206814-002AA15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-001AA1d8e5a09893c0…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N206814-002AA1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N206814-001AA1d06236e962d9…
2024-10-29 15:01 UTC2024-10N206814-002AA1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-001AA179d66fd596c7…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N206814-002AA179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-001AA1301d65b070ca…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N206814-002AA1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-001AA11e350fbaab3a…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N206814-002AA11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N206814-001AA18072bd15b7f6…
2024-05-31 18:47 UTC2024-05N206814-002AA18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-001AA15c6f7cd8ea54…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N206814-002AA15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N206814-001AA15d02ea3f76ae…
2022-04-08 23:34 UTC2022-04N206814-002AA15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N206814-001AA14b0b4de00fa7…
2022-04-04 05:41 UTC2022-04N206814-002AA14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N206814-001AA174a2ff9319b5…
2019-12-13 00:20 UTC2019-12N206814-002AA174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N206814-001AA1bb7c543d1eb4…
2022-03-09 01:35 UTC2022-03N206814-002AA1bb7c543d1eb4…

Observed Orange Book patent history#

Captured, Edition, Application-product table
CapturedEditionApplication-productPatentExpirationUse codeCoverage / statusSubmission dateSource SHA-256
2026-08-18 06:07:402026-07N206814-001125393142039-03-07Drug product2026-02-04caaa826d4ba7…
2026-08-18 06:07:402026-07N206814-002125393142039-03-07Drug product2026-02-04caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N206814-001125393142039-03-07Drug product2026-02-04011fe1cb6892…
2026-02-19 14:30 UTC2026-02N206814-002125393142039-03-07Drug product2026-02-04011fe1cb6892…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206814-001125393142039-03-07Drug product2026-02-04a50c72e98297…
2026-07-26 02:55 UTC · 3 captures of this ZIP2026-06N206814-002125393142039-03-07Drug product2026-02-04a50c72e98297…

Additional Listing Data#

Finished product
Yes
Brand name base
POKONZA potassium chloride
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
POTASSIUM CHLORIDE10 meq/15mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
660YQ98I10Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2734000Internal RxNorm lookup
2734004Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
2d938cbf-27aa-4f9c-a582-5564d3b72465Available on FDA.report

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
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
15370-307-04POKONZA potassium chloride118 mL in 1 BOTTLELIQUID1181
15370-307-08POKONZA potassium chloride237 mL in 1 BOTTLELIQUID2371
15370-307-16POKONZA potassium chloride473 mL in 1 BOTTLELIQUID4731

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
15370-307-08ML - Milliliter15370-3073d9346a1-3e3b-4948-9072-ec13dbe029b012026-03-17

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
POKONZA potassium chloridePOTASSIUM CHLORIDECarwin Pharmaceutical Associates, LLC2d938cbf-27aa-4f9c-a582-5564d3b724652026-01-22Warnings, Adverse reactionsExact identifier
application applno (NDA): 206814
application number: NDA206814
ndc (product): 15370-307
Potassium ChloridePOTASSIUM CHLORIDEGenus Lifesciences14cd12ee-a4a3-465a-9550-58c9ef0e4f212025-07-21Warnings, Adverse reactionsExact identifier
application applno (NDA): 206814
application number: NDA206814
Potassium ChloridePOTASSIUM CHLORIDEEndo USA, Inc.e5214432-3517-4a90-9412-036752bd11392025-02-10Warnings, Adverse reactionsExact identifier
application applno (NDA): 206814
application number: NDA206814

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2734004POKONZA 10 MEQ in 15 mL Oral SolutionPSN2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000potassium chloride 0.667 MEQ/mL Oral SolutionPSN2d938cbf-27aa-4f9c-a582-5564d3b724651
2734004potassium chloride 0.667 MEQ/ML Oral Solution [Pokonza]SBD2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000potassium chloride 0.667 MEQ/ML Oral SolutionSCD2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000K+ chloride 0.667 MEQ/ML Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734004K+ chloride 0.667 MEQ/ML Oral Solution [Pokonza]SY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734004Pokonza 10 MEQ (0.75 GM) per 15 ML Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734004Pokonza 5 % Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734004Pokonza 750 MG per 15 ML Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000Pot chloride 0.667 MEQ/ML Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734004Pot chloride 0.667 MEQ/ML Oral Solution [Pokonza]SY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000potassium chloride 10 MEQ (0.75 GM) per 15 ML Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000potassium chloride 5 % Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651
2734000potassium chloride 750 MG per 15 ML Oral SolutionSY2d938cbf-27aa-4f9c-a582-5564d3b724651

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
15370-307-0415370030704118 mL in 1 BOTTLE (15370-307-04) 118 ml2026-01-14NoNoCurrent
15370-307-0815370030708237 mL in 1 BOTTLE (15370-307-08) 237 ml2026-01-14NoNoCurrent
15370-307-1615370030716473 mL in 1 BOTTLE (15370-307-16) 473 ml2026-01-14NoNoCurrent