FDA.reportPublic FDA data

Stye

Product NDC
63736-238
11-digit product format
637360238
Labeler code
63736
Product ID
63736-238_22a277be-2268-4957-8066-ab2966ecbf93
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil and Petrolatum
Dosage form
GEL
Route
OPHTHALMIC
Labeler
Insight Pharmaceuticals LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2010-06-15
Substance
MINERAL OIL; PETROLATUM
Active strength
319; 577 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product
Yes
Brand name base
Stye
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL319 mg/g
PETROLATUM577 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
T5L8T28FGPInternal UNII lookup
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
579999Internal RxNorm lookup
1053146Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
f7eb8466-d8ea-4833-9bed-244ead38a3bfAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-238-24Stye24 in 1 CASEGEL245
63736-238-24Stye1 in 1 BOXGEL15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Mineral OilACTIVE INGREDIENTT5L8T28FGPSTYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]1
PetrolatumACTIVE INGREDIENT4T6H12BN9USTYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]1
Mineral OilACTIVE MOIETYT5L8T28FGPSTYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]1
PetrolatumACTIVE MOIETY4T6H12BN9USTYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]1
Stearic AcidINACTIVE INGREDIENT4ELV7Z65APSTYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]1
Wheat Germ OilINACTIVE INGREDIENT14C97E680PSTYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-238STYE (MINERAL OIL AND PETROLATUM) GEL [INSIGHT PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20240104_f7eb8466-d8ea-4833-9bed-244ead38a3bf.zip

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 7 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Vis Guard Lubricant Eye DropsPOLYVINYL ALCOHOL 1.4%Ulai Health LLCe9b0ed39-60c8-1093-e053-2a95a90a705b2026-01-13WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb4697319-438e-2ec8-e053-2a95a90abb562026-01-08WarningsExact identifier
application number: M018
carboxymethylcellulose sodiumCARBOXYMETHYLCELLULOSE SODIUMAvPAKb478a695-ded0-2e5f-e053-2995a90ac45e2026-01-08WarningsExact identifier
application number: M018
Lubricant Eye Drops SolutionPOLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOLAvPAKf5743b38-e3d2-a065-e053-2995a90a4b9a2026-01-08WarningsExact identifier
application number: M018
Plus Rinse Emergency EyewashPURIFIED WATERINNOVATIVE SAFETY SUPPLY INC.b3f47d26-39e4-4aea-bb92-358def52b6522026-01-08WarningsExact identifier
application number: M018
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsExact identifier
application number: M018
Polyvinyl Alcohol Eye Drops 1,4 % w/vPOLYVINYL ALCOHOL EYE DROPS 1,4 % W/VAurolabe8e09719-6e06-612b-e053-2995a90a79fc2026-01-08WarningsExact identifier
application number: M018
AuroviscHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabe9100312-b105-50a6-e053-2a95a90ac31f2026-01-08WarningsExact identifier
application number: M018
TheraTears Dry and TiredCARBOXYMETHYLCELLULOSE SODIUMMEDTECH PRODUCTS INC02b70e2d-8159-4637-a282-9eac1468e7862026-01-07WarningsExact identifier
application number: M018
VISTA Hypromellose Dry Eye ReliefHYPROMELLOSERed Wedding LLCb2c4954c-ed53-778a-e053-2a95a90ae0d02026-01-01WarningsExact identifier
application number: M018
Colirio Ojo De Aguila Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDEGrandall Distributing Co., Inc.31aa07e9-0cc9-2a77-e063-6394a90a4b9d2025-12-31WarningsExact identifier
application number: M018
Value Health by Prodose Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Prodose, Inc.3fafa362-a8a6-3f91-e063-6394a90a98b32025-12-31WarningsExact identifier
application number: M018
Signature Care Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLBetter Living Brands LLC6f1f4f58-3208-4b06-9afb-c4beeed093142025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporation6c449374-8847-4c4a-9073-1951ff31d4042025-12-30WarningsExact identifier
application number: M018
Target Lubricant Eye Drops High PerformancePOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTarget Corporationddc15dac-fbd8-42fa-80db-79f49fc6b9eb2025-12-30WarningsExact identifier
application number: M018
Nighttime Relief LubricantLIGHT MINERAL OIL, WHITE PETROLATUMAmerisource Bergen Drug Corp.fd6b2be8-7e00-3765-e053-6294a90a40612025-12-30WarningsExact identifier
application number: M018
Rugby Carboxymethylcellulose Sodium 0.5% Eye DropsCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratoriesfb84fc0b-9a62-812a-e053-6394a90aba0a2025-12-30WarningsExact identifier
application number: M018
Rugby Polyvinyl Alcohol 1.4% Lubricating Eye DropsPOLYVINYL ALCOHOLRugby Laboratories081673b2-5c74-1200-e063-6394a90ae3632025-12-30WarningsExact identifier
application number: M018
Medi-First Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUnifirst First Aid Corporationa4e651cc-adf0-af9e-e053-2995a90ace5a2025-12-30WarningsExact identifier
application number: M018
Green Guard Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMUniFirst First Aid Corporationc3f04fdb-9fc1-797d-e053-2995a90afe802025-12-30WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
579999mineral oil 31.9 % / petrolatum 57.7 % Ophthalmic OintmentPSNf7eb8466-d8ea-4833-9bed-244ead38a3bf5
1053146Stye 31.9 % / 57.7 % Ophthalmic OintmentPSNf7eb8466-d8ea-4833-9bed-244ead38a3bf5
1053146mineral oil 0.319 MG/MG / petrolatum 0.577 MG/MG Ophthalmic Ointment [Stye]SBDf7eb8466-d8ea-4833-9bed-244ead38a3bf5
579999mineral oil 0.319 MG/MG / petrolatum 0.577 MG/MG Ophthalmic OintmentSCDf7eb8466-d8ea-4833-9bed-244ead38a3bf5
579999mineral oil 31.9 % / petrolatum, white 57.7 % Ophthalmic OintmentSYf7eb8466-d8ea-4833-9bed-244ead38a3bf5
1053146Stye (mineral Oil 0.319 MG/MG / petrolatum, white 0.577 MG/MG) Ophthalmic OintmentSYf7eb8466-d8ea-4833-9bed-244ead38a3bf5
1053146Stye (mineral oil 31.9 % / petrolatum, white 57.7 % ) Ophthalmic OintmentSYf7eb8466-d8ea-4833-9bed-244ead38a3bf5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-238-246373602382424 BOX in 1 CASE (63736-238-24) / 1 TUBE in 1 BOX / 3.5 g in 1 TUBE24 box2010-06-150000-00-00NoNoCurrent