Physiosol

Product NDC
0409-6141
Requested package NDC
0409-6141-22
11-digit product format
004096141
Labeler code
0409
Product ID
0409-6141_f9023ddc-a430-47a3-a7a9-ede847e8b974
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, and MAGNESIUM CHLORIDE
Dosage form
IRRIGANT
Route
IRRIGATION
Labeler
Hospira, Inc.
Application
NDA017637
Marketing category
NDA
Marketing start
2011-02-11
Marketing end
2021-08-01
Substance
SODIUM CHLORIDE; SODIUM ACETATE ANHYDROUS; SODIUM GLUCONATE; POTASSIUM CHLORIDE; MAGNESIUM CHLORIDE
Active strength
526 mg/100mL; mg/100mL; mg/100mL; mg/100mL; mg/100mL
Pharmacologic classes
Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Potassium Compounds [CS],Potassium Salt [EPC],Osmotic Laxative [EPC],Increased Large Intestinal Motility [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE],Osmotic Activity [MoA],Calculi Dissolution Agent [EPC],Magnesium Ion Exchange Activity [MoA],Osmotic Laxative [EPC],Osmotic Activity [MoA],Inhibition Small Intestine Fluid/Electrolyte Absorption [PE],Increased Large Intestinal Motility [PE],Stimulation Large Intestine Fluid/Electrolyte Secretion [PE],Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]
NDC exclude flag
No
Listing certified through
0000-00-00
Current FDA listing
Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 1 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0409-61410409-6141-22DDiscontinued by firm2026-09-14

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Snapshot, Source SHA-256 table
Captured / source dateSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-05d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-26f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-312ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-28a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-21cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-10cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-31302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-20ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-08ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-03367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-09557ba5c1ecfa…9c80585c8c6e…

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-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N017637-002PHYSIOSOL IN PLASTIC CONTAINERMAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08

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 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-0884e616aacf4f…
2026-08-18 06:07:402026-07N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-0831067a03dcf5…
2025-08-23 18:47 UTC2025-08N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-086a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-0803ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-082680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-085bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-0879d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-081e350fbaab3a…
2024-05-31 18:47 UTC2024-05N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-088072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-085c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-085d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-084b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-0874a2ff9319b5…
2022-03-09 01:35 UTC2022-03N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-0887673890dc5c…
2021-03-12 10:30 UTC2021-03N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-085aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-088869cabd3fbd…
2020-11-12 02:37 UTC2020-11N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08c0c555d07b60…
2019-12-14 00:12 UTC2019-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-083f01610625f2…
2019-09-15 20:21 UTC2019-09N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08b00525d2431f…
2019-07-19 19:46 UTC2019-07N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-086a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-081c564ffb4f44…
2023-12-20 04:57 UTC2023-12N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-089b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-083f0d92c62455…
2023-05-13 08:27 UTC2023-05N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08053a50430f4f…
2023-01-26 05:58 UTC2023-01N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-083bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-083a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N017637-002PHYSIOSOL IN PLASTIC CONTAINER30MG/100ML;37MG/100ML;222MG/100ML;526MG/100ML;502MG/100MLSOLUTION / IRRIGATION1982-07-08f41ea6bd6efb…

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0409-6141-03ML - Milliliter0409-61415ed581ec-7cd8-42e4-8d35-1c912222043212012-07-24
0409-6141-09ML - Milliliter0409-614182e48668-77ba-4097-aa6d-02634216cdcb12012-07-24
0409-6141-22ML - Milliliter0409-61412219a7c8-c08d-479c-aa98-3bc47e6ee27012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
MAGNESIUM CHLORIDEACTIVE INGREDIENT02F3473H9OPHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
POTASSIUM CHLORIDEACTIVE INGREDIENT660YQ98I10PHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
SODIUM ACETATE ANHYDROUSACTIVE INGREDIENTNVG71ZZ7P0PHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
SODIUM CHLORIDEACTIVE INGREDIENT451W47IQ8XPHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
SODIUM GLUCONATEACTIVE INGREDIENTR6Q3791S76PHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
CHLORIDE IONACTIVE MOIETYQ32ZN48698PHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
SODIUM CATIONACTIVE MOIETYLYR4M0NH37PHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
HYDROCHLORIC ACIDINACTIVE INGREDIENTQTT17582CBPHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11
WATERINACTIVE INGREDIENT059QF0KO0RPHYSIOSOL (SODIUM CHLORIDE, SODIUM ACETATE ANHYDROUS, SODIUM GLUCONATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [HOSPIRA, INC.]11

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
0409-6141-220040961412224 BOTTLE, PLASTIC in 1 CASE (0409-6141-22) > 250 mL in 1 BOTTLE, PLASTIC2011-02-112021-08-01NoNoCurrent