FDA.reportPublic FDA data

REFRESH P.M.

Product NDC
0023-0240
11-digit product format
000230240
Labeler code
0023
Product ID
0023-0240_9e93a73f-478a-40fe-adca-9b1c30bce567
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
1990-04-23
Substance
MINERAL OIL; PETROLATUM
Active strength
425; 573 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 P.M.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL425 mg/g
PETROLATUM573 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
UniiT5L8T28FGP, 4T6H12BN9U
Rxcui702008

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0023-0240-04REFRESH P.M.1 in 1 CARTONOINTMENT19
0023-0240-04REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0240-21REFRESH P.M.1 in 1 CARTONOINTMENT19
0023-0240-21REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0240-04GM - Gram0023-0240936d6dc5-9398-41da-86c0-ba83881ea17012012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
mineral oilACTIVE INGREDIENTT5L8T28FGPREFRESH P.M. (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]3
petrolatumACTIVE INGREDIENT4T6H12BN9UREFRESH P.M. (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]3
mineral oilACTIVE MOIETYT5L8T28FGPREFRESH P.M. (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]3
petrolatumACTIVE MOIETY4T6H12BN9UREFRESH P.M. (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]3
lanolin alcoholsINACTIVE INGREDIENT884C3FA9HEREFRESH P.M. (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0023-0240REFRESH P.M. (MINERAL OIL, PETROLATUM) OINTMENT [ALLERGAN, INC.]8Current NDC, Legacy NDC, 4 package rows20240120_24365d64-cd94-41cc-a7e1-033102d98114.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
702008mineral oil 42.5 % / petrolatum 57.3 % Ophthalmic OintmentPSN24365d64-cd94-41cc-a7e1-033102d981149
702008mineral oil 0.425 MG/MG / petrolatum 0.573 MG/MG Ophthalmic OintmentSCD24365d64-cd94-41cc-a7e1-033102d981149
702008mineral oil 42.5 % / petrolatum, white 57.3 % Ophthalmic OintmentSY24365d64-cd94-41cc-a7e1-033102d981149

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0023-0240-04000230240041 TUBE in 1 CARTON (0023-0240-04) > 3.5 g in 1 TUBE1 tube1990-04-230000-00-00NoNoCurrent
0023-0240-21000230240211 TUBE in 1 CARTON (0023-0240-21) > 3.5 g in 1 TUBE1 tube1990-04-230000-00-00NoNoCurrent