FDA.reportPublic FDA data

Dry Eye Relief

Manufacturer
Similasan Corporation
Effective date
2019-03-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 02:11:13

Label at a glance#

ProductDry Eye Relief
Active ingredientATROPA BELLADONNA, EUPHRASIA STRICTA, MERCURIC CHLORIDE
Label structure13 sections

Indications and uses

According to homeopathic principles, the active ingredients in this medication temporarily minor symptoms such as: dry eye redness of eyes and lids reflex watering secondary to dry eye sensation of grittiness sensitivity to light

Dosage and administration

For adults and children age 2 and over: remove a single use dropper twist flat end with ball to remove squeeze plastic tip to release 2-3 drops into eye and discard applicator apply as needed throughout the day or night use a dropper for every application

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Belladonna* 6X

OTC - ACTIVE INGREDIENT SECTION

Enter section text here

*containing 0.000002% alkaloids calculated as hyoscyamine.

Purpose

OTC - PURPOSE SECTION

dryness, redness

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Euphrasia 6X

Purpose

OTC - PURPOSE SECTION

redness, inflammation

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Mercurius sublimatus 6X

Purpose

OTC - PURPOSE SECTION

dryness

Uses

INDICATIONS & USAGE SECTION

According to homeopathic principles, the active ingredients in this medication temporarily minor symptoms such as:

  • dry eye
  • redness of eyes and lids
  • reflex watering secondary to dry eye
  • sensation of grittiness
  • sensitivity to light

Warnings

WARNINGS SECTION

  • For external use only.
  • Initial exacerbation of symptoms may occur.
  • Use only if single-use dropper is intact.
  • To avoid contamination, do not touch the tip of the dropper to any surface. Do not reuse. Once opened, discard.
  • Contact wearers: consult a physician prior to using.

Do not use:

OTC - DO NOT USE SECTION

  • if the solution changes color or becomes cloudy

Stop use and ask a doctor if:

OTC - ASK DOCTOR SECTION

  • symptoms worsen or persist for more than 72 hours.
  • changes in vision occur.
  • you experience eye pain.

If pregnant or breast feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

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

For adults and children age 2 and over:

  • remove a single use dropper
  • twist flat end with ball to remove
  • squeeze plastic tip to release 2-3 drops into eye and discard applicator
  • apply as needed throughout the day or night
  • use a dropper for every application

Other information

INFORMATION FOR OWNERS/CAREGIVERS SECTION

Active ingredients are manufactured according to homeopathic principles and are therefore non-toxic and have no known side effects.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Phosphate buffer, Purified water

Questions?

OTC - QUESTIONS SECTION

Reach our representatives, M-F, 8am-5pm (MT), or our 24 hour recorded product information at 1-800-240-9780. Visit us: www.SimilasanUSA.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 59262-351-12
Similasan
Dry Eye
Relief
SINGLE-USE STERILE EYE DROPS
Preservative Free
0.4 ml/ 0.014 fl oz each
20 Sterile Single-Use Droppers

NDC 59262-351-12 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz each 20 Sterile Single-Use DroppersNDC 59262-351-12 Similasan Dry Eye Relief SINGLE-USE STERILE EYE DROPS Preservative Free 0.4 ml/ 0.014 fl oz each 20 Sterile Single-Use Droppers


DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
59262-351-122021-01-29C16284748780-1ba0f9c33-3018-a910-e053-dadaa90a0b85Similasan Dry Eye Relief Preservative Free

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
59262-351-12Dry Eye Relief20 in 1 CARTONSOLUTION/ DROPS208
59262-351-12Dry Eye Relief0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
59262-351DRY EYE RELIEF (BELLADONNA 6X, EUPHRASIA 6X, MERCURIUS SUBLIMATUS 6X) SOLUTION/ DROPS [SIMILASAN CORPORATION]8Legacy NDC, 2 package rows20190329_f3bad888-2207-4a78-abba-d3c667e30e5c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
59262-351-12EA - Each59262-3513c95ecd2-cd58-484b-ba8d-7dcc94a4fcb812022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ATROPA BELLADONNAACTIVE INGREDIENTWQZ3G9PF0H5
EUPHRASIA STRICTAACTIVE INGREDIENTC9642I91WL5
MERCURIC CHLORIDEACTIVE INGREDIENT53GH7MZT1R5
ATROPA BELLADONNAACTIVE MOIETYWQZ3G9PF0H5
EUPHRASIA STRICTAACTIVE MOIETYC9642I91WL5
MERCURIC CATIONACTIVE MOIETYED30FJ8Y425
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F5
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATEINACTIVE INGREDIENT5QWK6659565
WATERINACTIVE INGREDIENT059QF0KO0R5

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
59262-35159262-351-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 6 matching rows.

Name, UNII, Kind table
NameUNIIKind
ATROPA BELLADONNAWQZ3G9PF0HACTIB
EUPHRASIA STRICTAC9642I91WLACTIB
MERCURIC CHLORIDE53GH7MZT1RACTIB
WATER059QF0KO0RIACT
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FIACT

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 2 · 61 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE / ORAL40 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION / OPHTHALMIC2 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRAMUSCULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / OPHTHALMIC1.21 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRASYNOVIAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FOR SUSPENSION / ORAL60 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FOINTMENT / TOPICAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVESICAL38.25 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, DELAYED RELEASE / ORAL43 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRA-ARTICULAR28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS1.6 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, FILM COATED / ORAL0.01 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / BUCCAL0.35 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / TOPICAL0.14 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRALESIONAL3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / INTRAVENOUS115 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SUSPENSION / ORAL140 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / INTRATHECAL0.01 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / SUBCUTANEOUS0.11 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION/ DROPS / OPHTHALMIC1.15 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSYRUP / ORAL70 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / SOFT TISSUE3 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS1.3 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAVENOUS12.8 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / NASAL5 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / SUBLINGUAL6 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, EMULSION / INTRAVENOUS0.28 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, EXTENDED RELEASE / ORAL207 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956GEL / TOPICAL0.02 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRALESIONAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET, EXTENDED RELEASE / ORAL210 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / SUBCUTANEOUS20 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / ORAL140 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTROCHE / ORAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FTABLET / ORAL96 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION, SOLUTION / SUBCUTANEOUS0.3 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM, SOLUBLE / ORAL0.05 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLOZENGE / TRANSMUCOSAL112 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAVENOUS139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY / NASAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCREAM / TOPICAL0.36 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR8 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSUSPENSION / ORAL66 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSUSPENSION / OPHTHALMICNAExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FAEROSOL, FOAM / TOPICAL0.09 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956SOLUTION / ORAL63 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRATHECAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, DIHYDRATESODIUM PHOSPHATE, MONOBASIC, DIHYDRATE5QWK665956INJECTION / INTRAMUSCULAR12.8 mgExact identifier — unii candidate
13 equally ranked IID candidates

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
9cb069f8-c964-4a76-b161-f457857e6e8af3bad888-2207-4a78-abba-d3c667e30e5c2019-03-20WarningsExact identifier
spl id: 9cb069f8-c964-4a76-b161-f457857e6e8a
spl set id: f3bad888-2207-4a78-abba-d3c667e30e5c

Reported adverse events (FAERS/openFDA)#

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