Physiolyte
- Product NDC
- 0264-2205
- 11-digit product format
- 002642205
- Labeler code
- 0264
- Product ID
- 0264-2205_03ced4e7-7317-45fb-8303-54a924c7d281
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Sodium Chloride, Sodium Gluconate, Sodium Acetate, Potassium Chloride, and Magnesium Chloride
- Dosage form
- IRRIGANT
- Route
- IRRIGATION
- Labeler
- B. Braun Medical Inc.
- Application
- NDA019024
- Marketing category
- NDA
- Marketing start
- 1984-06-08
- Substance
- MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
- Active strength
- .03; .037; .37; .53; .5 g/100mL; g/100mL; g/100mL; g/100mL; g/100mL
- Pharmacologic classes
- Calculi Dissolution Agent [EPC], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Osmotic Laxative [EPC], Potassium Compounds [CS], Potassium Salt [EPC], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Orange Book products#
| Application-product | Trade name | Ingredient | Strength | Dosage form / route | TE codes | RLD / RS | Approval date |
|---|---|---|---|---|---|---|---|
| N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 |
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.
| Captured | Edition | Application-product | Trade name | Strength | Dosage form / route | Product TE source text | RLD / RS | Approval date | Source SHA-256 |
|---|---|---|---|---|---|---|---|---|---|
| 2026-02-19 14:30 UTC | 2026-02 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 011fe1cb6892… | ||
| 2025-12-14 10:44 UTC · 2 captures of this ZIP | 2025-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 31067a03dcf5… | ||
| 2025-08-23 18:47 UTC | 2025-08 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 6a471c1ec25d… | ||
| 2025-03-22 03:13 UTC · 3 captures of this ZIP | 2025-03 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | fd3edfee7708… | ||
| 2025-02-26 10:13 UTC · 3 captures of this ZIP | 2025-02 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | b8a1b40f171c… | ||
| 2025-01-19 17:59 UTC · 7 captures of this ZIP | 2025-01 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 03ed91905a0d… | ||
| 2024-12-13 21:23 UTC · 2 captures of this ZIP | 2024-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 2680178bc6a6… | ||
| 2024-09-14 05:58 UTC · 2 captures of this ZIP | 2024-09 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 5bbf6a4d5a75… | ||
| 2024-11-08 22:44 UTC · 3 captures of this ZIP | 2024-11 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | d8e5a09893c0… | ||
| 2024-10-29 15:01 UTC | 2024-10 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | d06236e962d9… | ||
| 2024-08-13 05:28 UTC · 3 captures of this ZIP | 2024-08 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 79d66fd596c7… | ||
| 2024-07-13 05:37 UTC · 2 captures of this ZIP | 2024-07 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 301d65b070ca… | ||
| 2024-06-18 03:08 UTC · 5 captures of this ZIP | 2024-06 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 1e350fbaab3a… | ||
| 2024-05-31 18:47 UTC | 2024-05 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 8072bd15b7f6… | ||
| 2022-06-29 02:47 UTC · 2 captures of this ZIP | 2022-06 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 5c6f7cd8ea54… | ||
| 2022-04-08 23:34 UTC | 2022-04 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 5d02ea3f76ae… | ||
| 2022-04-04 05:41 UTC | 2022-04 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 4b0b4de00fa7… | ||
| 2019-12-13 00:20 UTC | 2019-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 74a2ff9319b5… | ||
| 2022-03-09 01:35 UTC | 2022-03 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | bb7c543d1eb4… | ||
| 2021-12-28 21:50 UTC | 2021-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 782e0a99824c… | ||
| 2021-05-05 16:15 UTC · 3 captures of this ZIP | 2021-05 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 87673890dc5c… | ||
| 2021-03-12 10:30 UTC | 2021-03 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 5aa47cf7b7d7… | ||
| 2020-12-22 03:56 UTC | 2020-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 8869cabd3fbd… | ||
| 2020-11-12 02:37 UTC | 2020-11 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | c0c555d07b60… | ||
| 2019-12-14 00:12 UTC | 2019-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 3f01610625f2… | ||
| 2019-09-15 20:21 UTC | 2019-09 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | b00525d2431f… | ||
| 2019-07-19 19:46 UTC | 2019-07 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | ea99ee380514… | ||
| 2024-03-16 18:09 UTC · 4 captures of this ZIP | 2024-03 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 6a51e52b5d6a… | ||
| 2024-02-18 07:12 UTC | 2024-02 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 1c564ffb4f44… | ||
| 2023-12-20 04:57 UTC | 2023-12 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | ea1830bbd6c7… | ||
| 2023-11-28 05:40 UTC · 2 captures of this ZIP | 2023-11 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | a72a2bbeb626… | ||
| 2023-10-25 00:34 UTC · 2 captures of this ZIP | 2023-10 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 9b2671bbb829… | ||
| 2023-07-15 15:27 UTC · 2 captures of this ZIP | 2023-07 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | a67488948f0b… | ||
| 2023-06-13 01:57 UTC · 3 captures of this ZIP | 2023-06 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 3f0d92c62455… | ||
| 2023-05-13 08:27 UTC | 2023-05 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 053a50430f4f… | ||
| 2023-01-26 05:58 UTC | 2023-01 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 3bdfa0b2c4d7… | ||
| 2022-11-12 20:34 UTC · 5 captures of this ZIP | 2022-11 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | 3a93d1ddd44b… | ||
| 2022-10-28 04:53 UTC | 2022-10 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | f41ea6bd6efb… | ||
| 2022-09-29 23:25 UTC | 2022-09 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | e64feba35796… | ||
| 2022-07-09 03:26 UTC · 3 captures of this ZIP | 2022-07 | N019024-001 | PHYSIOLYTE IN PLASTIC CONTAINER | 30MG/100ML;37MG/100ML;370MG/100ML;530MG/100ML;500MG/100ML | SOLUTION / IRRIGATION | 1984-06-08 | cb3db0bc1861… |
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Physiolyte
- Listing expiration
- 2026-12-31
Active Ingredients#
| Ingredient | Strength |
|---|---|
| SODIUM CHLORIDE | .03 g/100mL |
| SODIUM GLUCONATE | .037 g/100mL |
| SODIUM ACETATE | .37 g/100mL |
| POTASSIUM CHLORIDE | .53 g/100mL |
| MAGNESIUM CHLORIDE | .5 g/100mL |
Harmonized UNII identifiers#
| Identifier | FDA.report destination |
|---|---|
| 451W47IQ8X | Internal UNII lookup |
| R6Q3791S76 | Internal UNII lookup |
| 4550K0SC9B | Internal UNII lookup |
| 660YQ98I10 | Internal UNII lookup |
| 02F3473H9O | Internal UNII lookup |
Harmonized RxCUI identifiers#
Harmonized SPL set identifiers#
| Identifier | FDA.report destination |
|---|---|
| 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | Available on FDA.report |
DailyMed Product Concepts#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0264-2205-00 | Physiolyte | 1000 mL in 1 CONTAINER | IRRIGANT | 1000 | 7 | |
| 0264-2205-00 | Physiolyte | 16 in 1 CASE | IRRIGANT | 16 | 7 |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0264-2205-00 | ML - Milliliter | 0264-2205 | 993b6d9d-32ff-4b24-a7ca-78ab51d92438 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 0264-2205 | PHYSIOLYTE (SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE) IRRIGANT [B. BRAUN MEDICAL INC.] | 7 | Current NDC, Legacy NDC, 2 package rows | 20230927_19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e.zip |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| Physiolyte | SODIUM CHLORIDE, SODIUM GLUCONATE, SODIUM ACETATE, POTASSIUM CHLORIDE, AND MAGNESIUM CHLORIDE | B. Braun Medical Inc. | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 2023-09-26 | Warnings, Adverse reactions | 019024 NDA019024 0264-2205 |
DailyMed RxNorm Mappings#
| RxCUI | RxNorm string | TTY | DailyMed | SPL version |
|---|---|---|---|---|
| 827351 | magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM in 100 mL Irrigation Solution | PSN | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Physiolyte 0.03 GM / 0.037 GM / 0.37 GM / 0.53 GM / 0.5 GM in 100 mL Irrigation Solution | PSN | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.005 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.09 MEQ/ML / sodium gluconate 0.023 MEQ/ML Irrigation Solution [Physiolyte] | SBD | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | magnesium chloride 0.00148 MEQ/ML / potassium chloride 0.005 MEQ/ML / sodium acetate 0.027 MEQ/ML / sodium chloride 0.09 MEQ/ML / sodium gluconate 0.023 MEQ/ML Irrigation Solution | SCD | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Magnesium Chloride 0.00148 MEQ/ML / K+ Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution [Physiolyte] | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Magnesium Chloride 0.00148 MEQ/ML / Pot Chloride 0.005 MEQ/ML / Sodium Acetate 0.027 MEQ/ML / NaCl 0.09 MEQ/ML / Sodium gluconate 0.023 MEQ/ML Irrigation Solution [Physiolyte] | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827351 | magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM per 100 ML Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Physiolyte (magnesium chloride 0.03 GM / potassium chloride 0.037 GM / sodium acetate 0.37 GM / sodium chloride 0.53 GM / sodium gluconate 0.5 GM per 100 ML) Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
| 827353 | Physiolyte Irrigation Solution | SY | 19c04dcb-d6f2-4624-afd4-1c7b7ddcb85e | 7 |
Packages#
| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|---|---|---|---|---|---|---|---|
| 0264-2205-00 | 00264220500 | 16 CONTAINER in 1 CASE (0264-2205-00) / 1000 mL in 1 CONTAINER | 16 container | 1984-06-08 | 0000-00-00 | No | No | Current |