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

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 Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U
Rxcui701984

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

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