Package Insert

Manufacturer
B. Braun Medical Inc.
Effective date
2026-09-18
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-09-29 01:07:35

Label at a glance#

ProductSterile Water
Active ingredientWATER
Label structure15 sections

Indications and uses

Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION ).

Dosage and administration

Use as directed by physician. This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The p...

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

Sterile Water for Irrigation USP is a sterile, hypotonic, nonpyrogenic irrigating fluid or pharmaceutic aid (solvent) entirely composed of Sterile Water for Injection USP. It is prepared by distillation and contains no antimicrobial or bacteriostatic agents or added buffers. The pH is 5.7 (5.0–7.0)

The plastic container is a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

Not made with natural rubber Latex, PVC or DEHP.

Bottle may exhibit some discoloration upon storage which does not impact product quality.

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY SECTION

Sterile Water for Irrigation USP is utilized for a variety of clinical indications. Because of its low refractive index (1.3325), water provides excellent visibility during endoscopic urological procedures. It is also utilized as a pharmaceutic aid, as well as in the preparation of enteral nutrient products.

Water is hypotonic and will cause hemolysis and will be readily absorbed by the tissues during surgical procedures; therefore, its use under such conditions is not recommended.

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Sterile Water for Irrigation USP is indicated for use as an irrigating fluid or pharmaceutic aid. Sterile Water may also be used as an adjunct in the preparation of non-intravenously administered nutrient mixtures (see DOSAGE AND ADMINISTRATION).

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

Not for injection.

WARNINGS

WARNINGS SECTION

Sterile Water for Irrigation USP is hypotonic and will cause hemolysis, and is not recommended for use during surgical procedures.

After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.

Discard unused portion of irrigating solution since it contains no preservative.

PRECAUTIONS

PRECAUTIONS SECTION

Use only if solution is clear and container and seal are intact.

ADVERSE REACTIONS

ADVERSE REACTIONS SECTION

None known.

OVERDOSAGE

OVERDOSAGE SECTION

None known.

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Irrigation

SPL UNCLASSIFIED SECTION

Use as directed by physician.

This drug product should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Nutrient Mixtures

SPL UNCLASSIFIED SECTION

Sterile Water for Irrigation USP may be used to prepare non-intravenously administered nutrient mixtures. It contains no electrolytes or other added substances. Refer to preparation instructions of particular mixture to be used. The plastic container may be used for administration of non-intravenous nutrient mixture to the patient as appropriate.

HOW SUPPLIED

HOW SUPPLIED SECTION

Sterile Water for Irrigation USP is supplied sterile and nonpyrogenic in plastic irrigating containers. The 1000 mL and 500 mL containers are packaged 16 per case.

NDC Cat. No. Size
 Sterile Water for Irrigation USP
(Canada DIN 01963961)
  
 0264-2101-00 R5000-01 1000 mL
 0264-2101-10 R5001-01 500 mL

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Do not warm above 150°F (66°C).

Bottle may exhibit some discoloration upon storage which does not impact product quality.

SPL UNCLASSIFIED SECTION

Revised: May 2026

PIC is a trademark of B. Braun Medical Inc.

Directions for Use of PIC™ (Plastic Irrigation Container)

SPL UNCLASSIFIED SECTION

Not for injection.

Aseptic technique is required.

  1. Caution – Before use, perform the following checks:
    (a) Read the label. Ensure solution is the one ordered and is within the expiration date. 
    (b) Invert container and inspect the solution in good light for cloudiness, haze, or particulate matter; check the container for leakage or damage. Any container which is suspect should not be used. 

    Use only if solution is clear and container and seal are intact.

    Bottle may exhibit some discoloration upon storage which does not impact product quality.
      Single-dose container. Discard unused portion.

  2. Outer Closure Removal – Grasp the container with one hand and turn the breakaway ring counterclockwise with the other hand until slight resistance is felt. Then, twisting the container in the opposite direction, turn the breakaway ring sharply until the entire outer cap is loose and can be lifted off. (Figure 1)
    Figure 1Figure 1
  3. Connect the administration set through the sterile set port according to set instructions (Figure 2) or remove screw cap and pour. 
    Figure 2Figure 2 
  4. Do not warm above 150°F (66°C) to assure minimal bottle distortion. Keep bottles upright.

SPL UNCLASSIFIED SECTION

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Imported by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Y36-003-125   LD-774-2

PRINCIPAL DISPLAY PANEL - 1000 mL Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sterile Water for Irrigation USP

Warnings: Hypotonic and Hemolytic

REF R5000-01
NDC 0264-2101-00
DIN 01963961
HK 23675

1000 mL
PIC™ Container

Rx only

Lot
Exp.

No antimicrobial agent or other substance has been added.

pH: 5.7 (5.0-7.0)

Not for Injection.
See Package Insert.

Use only if solution is clear and container and seal are intact.

Sterile, nonpyrogenic. Single-dose container. Discard unused portion.

Warning: Do not warm above 150°F (66°C).

Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing.

Dosage: See Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

Y37-002-594   LD-775-1

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Imported by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Sterile Water for Irrigation USP

1000 mL Container Label R5000-01
1000 mL Container Label R5000-01

PRINCIPAL DISPLAY PANEL - 500 mL Container

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sterile Water for Irrigation USP

Warnings: Hypotonic and Hemolytic

REF R5001-01
NDC 0264-2101-10
DIN 01963961
HK 23675

500 mL
PIC™ Container

Rx only

Lot
Exp.

No antimicrobial agent or other substance has been added.

pH: 5.7 (5.0-7.0)

Not for Injection.
See Package Insert.

Use only if solution is clear and container and seal are intact.

Sterile, nonpyrogenic. Single-dose container. Discard unused portion.

Warning: Do not warm above 150°F (66°C).

Recommended Storage: Room temperature (25°C). Avoid excessive heat. Protect from freezing.

Dosage: See Prescribing Information.

Not made with natural rubber latex, PVC or DEHP.

Y37-002-595   LD-776-1

B. Braun Medical Inc.
Bethlehem, PA 18018-3524 USA
1-800-227-2862

Imported by:
B. Braun of Canada, Ltd.
Scarborough, Ontario M1H 2W4

Sterile Water for Irrigation USP

500 mL Container Label R5001-01
500 mL Container Label R5001-01

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeCode 128(01)10302642101006GTIN-14: 10302642101006
GTIN storage (14 digits): 10302642101006
sterile-water-for-irrigation-usp-in-pic-3.jpg
BarcodeCode 128(01)10302642101105GTIN-14: 10302642101105
GTIN storage (14 digits): 10302642101105
sterile-water-for-irrigation-usp-in-pic-4.jpg

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0264-2101-002022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-002022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-102022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-102022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-502022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-502022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-702022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-702022-02-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-002022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-002022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-102022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-102022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-502022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-502022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-702022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only
0264-2101-702022-01-28C16284748780-1d6a99b39-8444-a426-e053-dadaa90af4c2Package Insert PIC™ (Plastic Irrigation Containers) Sterile Water for Irrigation USP Rx only

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0264-2101-00ML - Milliliter0264-2101d9c5422d-a816-41b3-a149-bdc2ffb1b40e12012-07-24
0264-2101-10ML - Milliliter0264-2101935c9218-4d07-4f94-aa90-9720665251cb12012-07-24
0264-2101-50ML - Milliliter0264-2101ab98144b-fa1b-4c5a-b91d-8b2d6089e7ef12012-07-24
0264-2101-70ML - Milliliter0264-21018cdf9e37-35cd-4b2c-8c44-b95f6ab41de412012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WATERACTIVE INGREDIENT059QF0KO0R5
WATERACTIVE MOIETY059QF0KO0R5

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0264-21010264-2101-00, 0264-2101-10, 0264-2101-50, 0264-2101-70

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 1 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RACTIB

Source Document#

Source XML · Source PDF

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82023-09-06full-release2026-05-31 20:52:55

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

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
N016734-001STERILE WATER IN PLASTIC CONTAINERSTERILE WATER FOR IRRIGATION100%LIQUID / IRRIGATIONATRLD, Approved before 1982

Therapeutic equivalence codes#

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

Application-product, TE code table
Application-productTE code
N016734-001AT

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 22:38:342026-08N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 198284e616aacf4f…
2026-08-18 06:07:402026-07N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 198231067a03dcf5…
2025-08-23 18:47 UTC2025-08N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19826a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 198203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19822680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19825bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 198279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19821e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19828072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19825c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19825d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19824b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 198274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 198287673890dc5c…
2021-03-12 10:30 UTC2021-03N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19825aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19828869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19823f01610625f2…
2019-09-15 20:21 UTC2019-09N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982b00525d2431f…
2019-07-19 19:46 UTC2019-07N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19826a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19821c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19829b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19823f0d92c62455…
2023-05-13 08:27 UTC2023-05N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982053a50430f4f…
2023-01-26 05:58 UTC2023-01N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19823bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 19823a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016734-001STERILE WATER IN PLASTIC CONTAINER100%LIQUID / IRRIGATIONATRLD, Approved before 1982f41ea6bd6efb…

Observed Orange Book normalized TE history#

Normalized TE history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTE codeOrderSource SHA-256
2026-09-14 22:38:342026-08N016734-001AT184e616aacf4f…
2026-08-18 06:07:402026-07N016734-001AT1caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N016734-001AT1011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N016734-001AT131067a03dcf5…
2025-08-23 18:47 UTC2025-08N016734-001AT16a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N016734-001AT1fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N016734-001AT1b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N016734-001AT103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N016734-001AT12680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N016734-001AT15bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N016734-001AT1d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N016734-001AT1d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N016734-001AT179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N016734-001AT1301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N016734-001AT11e350fbaab3a…
2024-05-31 18:47 UTC2024-05N016734-001AT18072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N016734-001AT15c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N016734-001AT15d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N016734-001AT14b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N016734-001AT174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N016734-001AT1bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N016734-001AT1782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N016734-001AT187673890dc5c…
2021-03-12 10:30 UTC2021-03N016734-001AT15aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N016734-001AT18869cabd3fbd…
2020-11-12 02:37 UTC2020-11N016734-001AT1c0c555d07b60…
2019-12-14 00:12 UTC2019-12N016734-001AT13f01610625f2…
2019-09-15 20:21 UTC2019-09N016734-001AT1b00525d2431f…
2019-07-19 19:46 UTC2019-07N016734-001AT1ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N016734-001AT16a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N016734-001AT11c564ffb4f44…
2023-12-20 04:57 UTC2023-12N016734-001AT1ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N016734-001AT1a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N016734-001AT19b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N016734-001AT1a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N016734-001AT13f0d92c62455…
2023-05-13 08:27 UTC2023-05N016734-001AT1053a50430f4f…
2023-01-26 05:58 UTC2023-01N016734-001AT13bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N016734-001AT13a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N016734-001AT1f41ea6bd6efb…

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
969bdf41-6565-42fb-8ac1-8661a928cc22f4284eb6-e553-46d4-90d8-efc80a90a4802023-09-06Warnings, Adverse reactionsExact identifier
spl set id: f4284eb6-e553-46d4-90d8-efc80a90a480

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.