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

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 1 of 26 · 512 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
NeutraflushEYEWASH STATION ADDITIVE CONCENTRATEAero Healthcare1d9ff2ef-9c9b-f367-e063-6294a90afa0e2026-07-24WarningsExact identifier
application number: M018
Droptics Dry Eye ReliefCARBOXYMETHYLCELLULOSE SODIUM,GLYCERIN,POLYSORBATE 80Droptics LLC29d7614b-f4b7-48e2-97c5-d1bff27731d22026-07-22WarningsExact identifier
application number: M018
GOOD NEIGHBOR PHARMACY ARTIFICAL TEARS LUBRICANT EYE DROPSPOLYVINYL ALCOHOL, POVIDONEAmerisourceBergence6852a8-c5e6-403d-a7b4-a2e85d1ebb1f2026-07-22WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLGlobal Equipment Companybc93a1e8-aa3c-6735-e053-2995a90ad6e82026-07-16WarningsExact identifier
application number: M018
Revitalize Energizing Eye DropsNAPHAZOLINE HYDROCHLORIDE ,PROPYLENE GLYCOLRevitalize Energy Inc.518aac87-1642-4b2f-bca1-b74d21261eea2026-07-16WarningsExact identifier
application number: M018
Polyvinyl AlcoholPOLYVINYL ALCOHOLAvPAKf18b61da-4033-341a-e053-2a95a90a8ebf2026-07-07WarningsExact identifier
application number: M018
Artificial TearsARTIFICIAL TEARSAvPAKf18bebf2-1936-658f-e053-2a95a90a50122026-07-07WarningsExact identifier
application number: M018
Retaine CMCCARBOXYMETHYLCELLULOSE SODIUMOCuSOFT LLCa3698c71-0c80-4246-be52-5e7d96f6c5402026-07-06WarningsExact identifier
application number: M018
Eyesaline Eyewash ConcentratePURIFIED WATERProtective Industrial Products, Inc.558e5926-9027-d3f6-e063-6294a90ab1212026-07-02WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a1d07e-0006-0c75-e063-6394a90a7acc2026-07-02WarningsExact identifier
application number: M018
Fendall 1000 Pure FlowPURIFIED WATERProtective Industrial Products, Inc.55a2f4da-bb1e-8ead-e063-6394a90af72e2026-07-02WarningsExact identifier
application number: M018
Sterile Eyesaline EyewashSTERILE EYESALINE EYEWASHProtective Industrial Products, Inc.55a290e8-8310-8be4-e063-6394a90abdce2026-07-02WarningsExact identifier
application number: M018
Eyesaline Emergency EyewashPURIFIED WATERProtective Industrial Products, Inc.55a261c2-725d-6765-e063-6294a90a32602026-07-02WarningsExact identifier
application number: M018
OHTrust Artifical EyedropSODIUM CHLORIDENanoplus Technology Co., Limited2ea26d96-704b-17bb-e063-6394a90a7e272026-07-01WarningsExact identifier
application number: M018
Fendall 2000 Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.37dead3e-60cb-88ae-e063-6294a90a8f702026-06-24WarningsExact identifier
application number: M018
Rohto Cool ReliefNAPHAZOLINE HYDROCHLORIDE, POLYSORBATE 80The Mentholatum Companydc8f1ff3-87ae-47ca-815f-5a0e34f8cf302026-06-19WarningsExact identifier
application number: M018
Rohto Sun and SportHYPROMELLOSE, POVIDONEThe Mentholatum Company8bcc8882-b886-4b55-9bc4-d4b92a41358f2026-06-19WarningsExact identifier
application number: M018
Rohto Dual Light ReliefHYPROMELLOSE, POVIDONEThe Mentholatum Company1b597f83-d7f1-cf93-e063-6394a90a99f72026-06-19WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUM 0.5%CARDINAL HEALTH 110, LLC. DBA LEADER51a2d74f-5ff3-9921-e063-6294a90a345a2026-06-15WarningsExact identifier
application number: M018
Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMRugby Laboratories51cadca6-a31b-c1b5-e063-6394a90a34d32026-06-15WarningsExact 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