FDA.reportPublic FDA data

Archies Dry Eye Relief

Manufacturer
Archie's Remedies | KC Pharmaceuticals, Inc. | Unimed Pharmaceuticals, Inc.
Effective date
2025-12-30
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:44

Label at a glance#

ProductArchies Dry Eye Relief
Active ingredientPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOL
Label structure9 sections

Dosage and administration

instill 1 or 2 drops in the affected eye(s) as needed

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Polyethylene glycol 400 0.4%

Propylene glycol 0.3%

Purposes

OTC - PURPOSE SECTION

Lubricant

Lubricant

Use

INDICATIONS & USAGE SECTION

  • for the temporary relief of burning and irritation of the eye due to dryness of the eye

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • if this solution changes color or becomes cloudy
  • if you are sensitive to any ingredient in this product

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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you feel eye pain
  • changes in vision occur
  • redness or irritation of the eye(s) gets worse or lasts more than 72 hours

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • instill 1 or 2 drops in the affected eye(s) as needed

Other information

OTHER SAFETY INFORMATION

  • store at 15°-25°C (59°-77°F)
  • use only if single-use container is intact
  • use before expiration date marked on container
  • RETAIN THIS CARTON FOR FUTURE REFERENCE

Inactive ingredients

INACTIVE INGREDIENT SECTION

boric acid, hypromellose, potassium chloride, purified water, sodium chloride. May contain hydrochloric acid and/or sodium hydroxide to adjust pH.

Archie's Dry Eye Relief 30ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Archie's Dry Eye Relief 30ctArchie's Dry Eye Relief 30ct

Archie's Dry Eye Relief 60ct

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Archie's Dry Eye Relief 60ctArchie's Dry Eye Relief 60ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
477589polyethylene glycol 400, 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionPSN3
477589polyethylene glycol 400 4 MG/ML / propylene glycol 3 MG/ML Ophthalmic SolutionSCD3
477589PEG 400 0.4 % / propylene glycol 0.3 % Ophthalmic SolutionSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130197644107315GTIN-13: 0197644107315
EAN-13: 0197644107315
GTIN-12: 197644107315
UPC-A: 197644107315
GTIN storage (14 digits): 00197644107315		Archies Dry Eye Relief 60ct.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
9e37788c-b1bf-42ae-aac9-b60601606144Product name820260122
1527ac37-808d-43be-a63e-74e1258dbe46Product name920250219
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cefa60e2-a5b5-493e-9c54-24735b7dc509Product name620240814
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9fcb7a91-de07-4f00-aabf-e4d6fda403d5Product name820230322
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
0ec3537a-6c9b-432a-896c-b9ea8723049aProduct name920200701
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
7916de40-e296-41f0-b811-6d0df1a33e2cProduct name920180627
cefa60e2-a5b5-493e-9c54-24735b7dc509Product name220171212
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
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684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83737-001-30Archies Dry Eye Relief0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.43
83737-001-30Archies Dry Eye Relief30 in 1 BOXSOLUTION/ DROPS303
83737-001-60Archies Dry Eye Relief60 in 1 BOXSOLUTION/ DROPS603
83737-001-60Archies Dry Eye Relief0.4 mL in 1 VIAL, SINGLE-USESOLUTION/ DROPS0.43

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
83737-00183737-001-30, 83737-001-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM CHLORIDE660YQ98I10IACT
POLYETHYLENE GLYCOL 400B697894SGQACTIB
WATER059QF0KO0RIACT
HYDROCHLORIC ACIDQTT17582CBIACT
SODIUM CHLORIDE451W47IQ8XIACT
PROPYLENE GLYCOL6DC9Q167V3ACTIB
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
SODIUM HYDROXIDE55X04QC32IIACT
BORIC ACIDR57ZHV85D4IACT

Source Document#

Source XML

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
Archies Dry Eye ReliefPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLArchie's Remedies07da099b-6b7f-984d-e063-6294a90a12ac2025-12-30WarningsExact identifier
ndc (package): 83737-001-30
ndc (package): 83737-001-60
ndc (product): 83737-001
ndc11 (package): 83737000130
ndc11 (package): 83737000160
spl id: 474a8539-a4cf-d2de-e063-6394a90aa58b
spl set id: 07da099b-6b7f-984d-e063-6294a90a12ac

Reported adverse events (FAERS/openFDA)#

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