PUR-WASH

Manufacturer
Niagara Pharmaceuticals Inc.
Effective date
2025-01-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:41:47

Label at a glance#

ProductPUR-WASH
Active ingredientWATER
Label structure11 sections

Dosage and administration

remove tamper evident seal and cap replace with sterile eyecup provided avoid contamination of rim and inside surfaces of the eyecup place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Purified water 98.3%

Purpose

OTC - PURPOSE SECTION

Eyewash

Use

INDICATIONS & USAGE SECTION

For cleansing the eye to help relieve irritation or burning by removing loose foreign material

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if you experience any open wounds in or near the eyes and obtain immediate medical treatment
  • if solution changes color or becomes cloudy

When using this product

OTC - WHEN USING SECTION

  • to avoid contamination, do not touch tip of container to any surface
  • do not reuse
  • once opened, discard

OTC - STOP USE SECTION

Stop use and ask a doctor if you have any of the following

  • continued redness or irritation of the eye
  • condition worsens or persists
  • eye pain
  • changes in vision

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • remove tamper evident seal and cap
  • replace with sterile eyecup provided
  • avoid contamination of rim and inside surfaces of the eyecup
  • place eyecup surface to the affected eye, pressing tightly to prevent the escape of the liquid and tilt the head backward
  • open eyelids wide and rotate eyeball while controlling the rate of flow of solution by pressure on the bottle to ensure thorough bathing with the wash

Other information

SPL UNCLASSIFIED SECTION

  • lot number is printed on the bottle
  • store at 20° to 25° C [68° to 77° F]
  • for your protection, this bottle has an imprinted white seal with black printing "TAMPER EVIDENT SEAL"
  • do not use if this seal is missing or broken
  • use before expiration date marked on bottle

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, sodium borate, sodium chloride

Questions ?

OTC - QUESTIONS SECTION

☎ Call 905 690-6277 9 a.m. to 5 p.m. EST Mon-Fri

SPL UNCLASSIFIED SECTION

Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough ON L9H 7P3

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pur-Wash

Purified Water, 98.3%
Ophthalmic Solution
Eyewash

Single Use

Manufactured by:
Niagara Pharmaceuticals Inc.
60 Innovation Dr.
Flamborough ON L9H 7P3
Made in Canada

Sterile Solution

32 Fl Oz [946 mL]

PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 946 mL Bottle Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65785-164PUR-WASH (WATER) SOLUTION [NIAGARA PHARMACEUTICALS INC.]3Legacy NDC20250130_c3225d26-a520-4bfb-bf9c-80340f1b830e.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WaterACTIVE INGREDIENT059QF0KO0R1
WaterACTIVE MOIETY059QF0KO0R1
Boric AcidINACTIVE INGREDIENTR57ZHV85D41
Sodium BorateINACTIVE INGREDIENT91MBZ8H3QO1
Sodium ChlorideINACTIVE INGREDIENT451W47IQ8X1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
65785-16465785-164-01, 65785-164-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 3 · 157 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
Boric AcidBORIC ACIDR57ZHV85D4GEL / OPHTHALMIC0.5 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAMUSCULAR90 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRATHECAL131 mgExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SHAMPOO / TOPICAL2 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SUSPENSION / AURICULAR (OTIC)0.6 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XIMPLANT / SUBCUTANEOUS77 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SOLUTION / OPHTHALMIC0.9 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRADERMAL7 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / AURICULAR (OTIC)0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium BorateSODIUM BORATE91MBZ8H3QOSOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
6 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XELIXIR / ORAL1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERINEURAL648 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGEL / VAGINAL10 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4SUSPENSION/ DROPS / TOPICAL0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, COATED / ORAL54.7 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAMUSCULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / PERIDURAL8.07 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / SOFT TISSUE26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / INTRATYMPANIC2 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, FILM COATED / ORAL100 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / IONTOPHORESIS0.6 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION, CONCENTRATE / INTRAOCULAR0.86 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSPRAY, METERED / NASAL36 mgExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4INJECTION, SOLUTION / INTRAVENOUS210 mgExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1800 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLOTION / TOPICAL0.3 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / INTRAVESICAL351 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION, LIPOSOMAL / EPIDURAL11 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVENOUS90 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACAVITARY0.82 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSUSPENSION / RESPIRATORY (INHALATION)43 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCAPSULE, EXTENDED RELEASE / ORAL41 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRACARDIAC70 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / NASAL330 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTERIAL278 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SUSPENSION / INTRAVENOUS0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4EMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOAP / TOPICAL1.26 %w/wExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRA-ARTICULAR26 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / SUBARACHNOID0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XCAPSULE / ORAL6 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, DELAYED RELEASE / ORAL97 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRALESIONAL0.9 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYRUP / ORAL40 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSYSTEM / TOPICAL3.1 mgExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4JELLY / VAGINAL1 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAVITREAL10 %w/vExact identifier — unii candidate
134 equally ranked IID candidates
Boric AcidBORIC ACIDR57ZHV85D4EMULSION / TOPICAL1.3 %w/wExact identifier — unii candidate
17 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XPOWDER, FOR SUSPENSION / ORAL98 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSOLUTION / INTRAVASCULARNAExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRAMUSCULAR1486 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, POWDER, FOR SOLUTION / INTRAPLEURAL226 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XTABLET, ORALLY DISINTEGRATING / ORAL10 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XLIQUID / INTRAMUSCULAR17 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / INTRATHECAL9 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION, SOLUTION / EPIDURAL3535 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XGRANULE, FOR SUSPENSION / ORAL162 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XSPRAY / NASAL30 mgExact identifier — unii candidate
134 equally ranked IID candidates
Sodium ChlorideSODIUM CHLORIDE451W47IQ8XINJECTION / SUBCUTANEOUS1486 mgExact identifier — unii candidate
134 equally ranked IID candidates

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
N022305-001PUR-WASHPURIFIED WATER98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01

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 22:38:342026-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0184e616aacf4f…
2026-08-18 06:07:402026-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013f01610625f2…
2019-09-15 20:21 UTC2019-09N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01b00525d2431f…
2019-07-19 19:46 UTC2019-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-013a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N022305-001PUR-WASH98.3%SOLUTION / OPHTHALMICRLD, RS2011-09-01f41ea6bd6efb…

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
38e27682-582f-fc88-e063-6394a90a8abcc3225d26-a520-4bfb-bf9c-80340f1b830e2025-07-01WarningsExact identifier
spl set id: c3225d26-a520-4bfb-bf9c-80340f1b830e

Reported adverse events (FAERS/openFDA)#

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