FDA.reportPublic FDA data

REFRESH P.M.

Product NDC
0023-0667
11-digit product format
000230667
Labeler code
0023
Product ID
0023-0667_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
2016-08-26
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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
REFRESH P.M.MINERAL OIL, PETROLATUMAllergan, Inc.24365d64-cd94-41cc-a7e1-033102d981142022-06-30WarningsExact identifier

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

warnings

Warnings For external use only. To avoid contamination, do not touch tip of container to any surface. Replace cap after using. Stop use and ask a doctor if you experience eye pain, changes in vision, continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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
0023-0667-04REFRESH P.M.1 in 1 CARTONOINTMENT19
0023-0667-04REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0667-21REFRESH P.M.3.5 g in 1 TUBEOINTMENT3.59
0023-0667-21REFRESH P.M.1 in 1 CARTONOINTMENT19

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0023-0667-04GM - Gram0023-066741a5485b-ec90-4454-b851-436d83e34c4b12022-12-07

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
0023-0667REFRESH 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
0023-0667-04000230667041 TUBE in 1 CARTON (0023-0667-04) / 3.5 g in 1 TUBE1 tube2016-08-260000-00-00NoNoCurrent
0023-0667-21000230667211 TUBE in 1 CARTON (0023-0667-21) / 3.5 g in 1 TUBE1 tube2016-08-26YesNoCurrent