FDA.reportPublic FDA data

REFRESH LACRI-LUBE

Product NDC
0023-0312
11-digit product format
000230312
Labeler code
0023
Product ID
0023-0312_b6d64a52-8a8a-4c90-ac67-41a32cc3c78a
Type
HUMAN OTC DRUG
Nonproprietary name
mineral oil, petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
Allergan, Inc.
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
1977-12-15
Substance
MINERAL OIL; PETROLATUM
Active strength
425; 568 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
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
REFRESH LACRI-LUBE
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL425 mg/g
PETROLATUM568 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 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
701984Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
d232a44b-516d-4cdf-a4e7-c3a9a50dc7afAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-0312-04REFRESH LACRI-LUBE1 in 1 CARTONOINTMENT18
0023-0312-04REFRESH LACRI-LUBE3.5 g in 1 TUBEOINTMENT3.58
0023-0312-07REFRESH LACRI-LUBE1 in 1 CARTONOINTMENT18
0023-0312-07REFRESH LACRI-LUBE7 g in 1 TUBEOINTMENT78

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0312-04GM - Gram0023-031220b39866-d70e-43a9-aba4-f2788fd84ed812012-07-24
0023-0312-07GM - Gram0023-0312908fe98b-82bb-4d73-892c-9c93a24b96d612012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mineral oilACTIVE INGREDIENTT5L8T28FGPREFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]2
petrolatumACTIVE INGREDIENT4T6H12BN9UREFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]2
mineral oilACTIVE MOIETYT5L8T28FGPREFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]2
petrolatumACTIVE MOIETY4T6H12BN9UREFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]2
chlorobutanolINACTIVE INGREDIENTHM4YQM8WRCREFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]2
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEREFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]2
MINERAL OILACTIVE INGREDIENTT5L8T28FGPMINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMACTIVE INGREDIENT4T6H12BN9UMINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1
MINERAL OILACTIVE MOIETYT5L8T28FGPMINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1
PETROLATUMACTIVE MOIETY4T6H12BN9UMINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1
CHLOROBUTANOLINACTIVE INGREDIENTHM4YQM8WRCMINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1
LANOLIN ALCOHOLSINACTIVE INGREDIENT884C3FA9HEMINERAL OIL (LACRI-LUBE) OINTMENT [REBEL DISTRIBUTORS CORP]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0312REFRESH LACRI-LUBE (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]7Current NDC, Legacy NDC, 4 package rows20231215_d232a44b-516d-4cdf-a4e7-c3a9a50dc7af.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 2 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VedlubeMINERAL OIL AND WHITE PETROLATUM LUBRICANT EYE OINTMENTVEDCO INC55d126fa-7489-4307-824e-b6957e57d4e92026-07-31WarningsExact identifier
application number: M018
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
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
701984mineral oil 42.5 % / petrolatum 56.8 % Ophthalmic OintmentPSNd232a44b-516d-4cdf-a4e7-c3a9a50dc7af8
701984mineral oil 0.425 MG/MG / petrolatum 0.568 MG/MG Ophthalmic OintmentSCDd232a44b-516d-4cdf-a4e7-c3a9a50dc7af8
701984mineral oil 42.5 % / petrolatum, white 56.8 % Ophthalmic OintmentSYd232a44b-516d-4cdf-a4e7-c3a9a50dc7af8
701984mineral oil 42.5 % / petrolatum 56.8 % Ophthalmic OintmentPSN3f0ec253-6179-4609-8a67-00dbefc550331
701984mineral oil 0.425 MG/MG / petrolatum 0.568 MG/MG Ophthalmic OintmentSCD3f0ec253-6179-4609-8a67-00dbefc550331
701984mineral oil 42.5 % / petrolatum, white 56.8 % Ophthalmic OintmentSY3f0ec253-6179-4609-8a67-00dbefc550331

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-0312-04000230312041 TUBE in 1 CARTON (0023-0312-04) / 3.5 g in 1 TUBE1 tube1977-12-150000-00-00NoNoCurrent
0023-0312-07000230312071 TUBE in 1 CARTON (0023-0312-07) / 7 g in 1 TUBE1 tube1977-12-150000-00-00NoNoCurrent