Manzanilla Sophia Herbal Eye Drops

Manufacturer: LABORATORIOS SOPHIA, S.A. DE C.V.
Effective date: 2024-01-09
Label type: HUMAN OTC DRUG LABEL
Version: 9
Source: full-release
Hydrated at: 2026-06-01 02:25:37

Label at a glance#

ProductManzanilla Sophia

Active ingredientMATRICARIA RECUTITA

Label structure12 sections

Storage and handling

Other information store at room temperature. Do not use if imprinted seal around cap is broken or missing

Contacts and useful links#

PhoneLabel contact1-866-202-8871

Websitewww.manzanillasophia.com

www.manzanillasophia.com

Websitewww.sophialabs.com

www.sophialabs.com

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Chamomile (Matricaria chamomilla L.) 3X HPUS

"HPUS" indicates that this ingredient is officially monographed in the Homeopathic Pharmacopoeia of the United States.

OTC - PURPOSE SECTION

Purpose

Eye moisturizer

INDICATIONS & USAGE SECTION

Use* to refresh and replenish moisture to eyes.

WARNINGS SECTION

Warnings

For external use only

OTC - DO NOT USE SECTION

Do not use if solution changes color or becomes cloudy

OTC - WHEN USING SECTION

When using this product

do not touch tip of container to any surface to avoid contamination
replace cap after using

OTC - STOP USE SECTION

Stop use and ask a doctor if

you feel eye pain
changes in vision occur
redness or irritation of the eye lasts
condition worsens or lasts more than 72 hours

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

DOSAGE & ADMINISTRATION SECTION

Directions

Put 2 drops into each eye as needed

STORAGE AND HANDLING SECTION

Other information

store at room temperature.

Do not use

if imprinted seal around cap is broken or missing

INACTIVE INGREDIENT SECTION

Inactive ingredients Benzalkonium chloride (as preservative), sodium chloride, sodium phosphate dibasic monohydrate, sodium phosphate monobasic monohydrate, water for injection

OTC - QUESTIONS SECTION

Questions?

1-866-202-8871

www.manzanillasophia.com

SPL UNCLASSIFIED SECTION

*Claims based on traditional homeopathic practice, not accepted medical evidence. Not FDA evaluated.

SPL UNCLASSIFIED SECTION

NDC 57619-400-01

Distributed by:

LABS SOPHIA USA, INC.

1790 Hughes Landing Blvd Suite 400

The Woodlands, TX 77380

MADE IN MEXICO

www.sophialabs.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HOMEOPATHIC

Manzanilla Sophia™

Chamomile

Herbal Eye Drops

REFRESH YOUR EYES

Cleanses

Soothes

0.5 FL OZ (15 mL)

STERILE

Manzanilla Sophia 11-2021

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
726062af-1135-4707-a1d7-57256991bbf9	Product name	2	20250226
19c71a3d-ed9c-166b-a7e5-38c250c35631	Product name	1	20140508

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
57619-400	MANZANILLA SOPHIA (CHAMOMILE (MATRICARIA CHAMOMILLA L.)) SOLUTION/ DROPS [LABORATORIOS SOPHIA, S.A. DE C.V.]	9	Legacy NDC	20240112_9245ab82-e9fa-48c8-a412-a5cbc47e6033.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
MATRICARIA RECUTITA	ACTIVE INGREDIENT	G0R4UBI2ZZ	6
MATRICARIA RECUTITA	ACTIVE MOIETY	G0R4UBI2ZZ	6
BENZALKONIUM CHLORIDE	INACTIVE INGREDIENT	F5UM2KM3W7	6
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	6
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	INACTIVE INGREDIENT	22ADO53M6F	6
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	INACTIVE INGREDIENT	593YOG76RN	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

Manzanilla Sophia
Chamomile (Matricaria Chamomilla L.)
BENZALKONIUM CHLORIDE
WATER
SODIUM CHLORIDE
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
MATRICARIA RECUTITA

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
57619-400	57619-400-01

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
Name	UNII	Kind
BENZALKONIUM CHLORIDE	F5UM2KM3W7	IACT
WATER	059QF0KO0R	IACT
SODIUM CHLORIDE	451W47IQ8X	IACT
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	IACT
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	IACT
MATRICARIA RECUTITA	G0R4UBI2ZZ	ACTIB

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 5 · 242 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / ENDOTRACHEAL		68 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / SUBCUTANEOUS	0.11 %w/v		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / PARENTERAL		584 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS		2922 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SOLUTION / INTRAVESICAL	38.25 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SUSPENSION / OPHTHALMIC	NA		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, FILM COATED / ORAL		100 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / AURICULAR (OTIC)	0 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	JELLY / NASAL	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SHAMPOO / TOPICAL		150 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SOLUTION / ORAL		140 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INSERT / INTRAOCULAR	0.02 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	LOTION, AUGMENTED / TOPICAL		10 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, EXTENDED RELEASE / ORAL	335.1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRADERMAL	7 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SYRUP / ORAL		70 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / EPIDURAL		3535 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAPERITONEAL	0.54 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / SOFT TISSUE		3 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION, CONCENTRATE / SUBCUTANEOUS	0.86 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SOLUTION / SUBARACHNOID	0.9 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION / AURICULAR (OTIC)	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	GEL / OPHTHALMIC	0.01 %w/w		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / INTRAMUSCULAR	9 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	SPRAY, METERED / NASAL		7 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION / INTRAMUSCULAR		36 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRA-ARTICULAR		26 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE / ORAL	40 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	1.84 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / RESPIRATORY (INHALATION)		108 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAVENOUS		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	INJECTION, SUSPENSION / INTRAMUSCULAR		13 mg	Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR		8 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / INTRACAUDAL		210 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	INJECTION / INTRAMUSCULAR		1 mg	Exact identifier — unii candidate 24 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SUSPENSION/ DROPS / AURICULAR (OTIC)	0.02 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	TABLET, FILM COATED / ORAL	0.11 mg		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION / DENTAL	0.4 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRAMUSCULAR		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, POWDER, FOR SOLUTION / INTRATHECAL	1.35 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS		1751 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, EXTENDED RELEASE / ORAL		207 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	ELIXIR / ORAL	1 mg		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / INTRAMUSCULAR		17 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	TABLET, DELAYED RELEASE / ORAL		97 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	FILM, SOLUBLE / ORAL	0.05 mg		Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	CAPSULE, DELAYED RELEASE / ORAL		43 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SOLUTION / INTRAMUSCULAR		90 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	GEL / VAGINAL	10 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	CREAM / TOPICAL	0.4 %w/w		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	LIQUID / SUBCUTANEOUS	0.7 %w/v		Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE	593YOG76RN	SOLUTION / TOPICAL	0.46 %w/v		Exact identifier — unii candidate 36 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	SUSPENSION / ORAL		1126 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	SODIUM PHOSPHATE, DIBASIC, ANHYDROUS	22ADO53M6F	INJECTION / INTRA-ARTICULAR		28 mg	Exact identifier — unii candidate 48 equally ranked IID candidates
BENZALKONIUM CHLORIDE	BENZALKONIUM CHLORIDE	F5UM2KM3W7	SOLUTION/ DROPS / TOPICAL	0.01 %w/v		Exact identifier — unii candidate 24 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRASYNOVIAL		4 mg	Exact identifier — unii candidate 134 equally ranked IID candidates
SODIUM CHLORIDE	SODIUM CHLORIDE	451W47IQ8X	INJECTION, SUSPENSION / INTRALESIONAL		13 mg	Exact identifier — unii candidate 134 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
40ad5d04-5f17-855e-e063-6394a90a2d58			9245ab82-e9fa-48c8-a412-a5cbc47e6033	2025-10-08	Warnings	Exact identifier spl set id: 9245ab82-e9fa-48c8-a412-a5cbc47e6033

Reported adverse events (FAERS/openFDA)#

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