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

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage0023-02400023-0240-04DDiscontinued by firm2026-10-15
excluded packagepackage0023-02400023-0240-21DDiscontinued by firm2026-10-15

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-050023-0240-21d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-050023-0240-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-260023-0240-21f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-260023-0240-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-310023-0240-212ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-310023-0240-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-280023-0240-21a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-280023-0240-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-210023-0240-21cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-210023-0240-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-100023-0240-21cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-100023-0240-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-310023-0240-21302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-310023-0240-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-200023-0240-21ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-200023-0240-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-100023-0240-210efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-100023-0240-040efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-080023-0240-21ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-080023-0240-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-030023-0240-21367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-030023-0240-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-090023-0240-21557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-090023-0240-04557ba5c1ecfa…9c80585c8c6e…

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 P.M.
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL425 mg/g
PETROLATUM573 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
702008Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
24365d64-cd94-41cc-a7e1-033102d98114Available on FDA.report

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#

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

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 18 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OASIS Tears Preservative-Free Lubricant EyeGLYCERINOASIS Medical, Inc.d9d71b1d-82a6-42e7-9ef2-2d041daef9362024-12-23WarningsExact identifier
application number: M018
Ancient Secrets Breathe AgainSODIUM CHLORIDELOTUS BRANDS, INC.c6d2bab0-d363-4c09-a71b-ae15db915b372024-12-18WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMMEDTECH PRODUCTS INC77f504c1-b8e0-4371-ac3e-9d453d84714b2024-12-13WarningsExact identifier
application number: M018
TheraTears ExtraCARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDMEDTECH PRODUCTS INCf1845041-9d8d-42a0-a2cb-68def7a5aac72024-12-13WarningsExact identifier
application number: M018
Fendall Pure FlowPURIFIED WATERHoneywell Safety Products USA, Inc.afda6fc3-7615-b0be-e053-2995a90a62082024-12-10WarningsExact identifier
application number: M018
Systane NighttimeMINERAL OIL AND WHITE PETROLATUMAlcon Laboratories, Inc.4689c59c-5721-3f91-6c85-e41501998fd02024-12-05WarningsExact identifier
application number: M018
GenTeal Tears NIGHT-TIMEMINERAL OIL, WHITE PETROLATUMAlcon Laboratories, Inc.9d5998a7-4f59-4293-87da-8419650a524d2024-12-05WarningsExact identifier
application number: M018
Visine Red Eye Total Comfort and Tears Dry Eye ReliefTETRAHYDROZOLINE HCL, POLYETHYLENE GLYCOL 400, ZINC SULFATEKenvue Brands LLC0bc0d6e7-9195-db6b-e063-6294a90aef042024-11-14WarningsExact identifier
application number: M018
Visine Red Eye ComfortTETRAHYDROZOLINE HYDROCHLORIDEKenvue Brands LLCd7abd7cb-e094-481f-bea5-a5983e2c9ef42024-11-13WarningsExact identifier
application number: M018
Visine Red Eye Hydrating Comfort Eye DropsTETRAHYDROZOLINE HYDROCHLORIDE AND POLYETHYLENE GLYCOL 400Kenvue Brands LLCa9a90de6-3172-4d34-984b-f4442f880e3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLC2de7a41d-661d-495f-89b4-5690664a3a3d2024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye Relief Eye DropsPOLYETHYLENE GLYCOL 400Kenvue Brands LLCd9d3f000-3ce4-4ba2-a7fb-491b44eb3fa12024-11-13WarningsExact identifier
application number: M018
Visine Dry Eye ReliefPOLYETHYLENE GLYCOL 400Kenvue Brands LLCa4c57620-778f-4434-9105-ead2f85c58842024-11-13WarningsExact identifier
application number: M018
Visine A.C. Itchy Eye ReliefTETRAHYDROZOLINE HYDROCHLORIDE AND ZINC SULFATE, UNSPECIFIED FORMKenvue Brands LLC257b9666-0163-499b-9673-bf6f4d6899b12024-11-13WarningsExact identifier
application number: M018
Eyewash Station Additive ConcentrateCHLORHEXIDINE GLUCONATE AND PROPYLENE GLYCOLAcme United Corporationf19fbe28-b928-7c6e-e053-2995a90a43cb2024-11-09WarningsExact identifier
application number: M018
RUGBY EYE WASHWATER, PURIFIEDA-S Medication Solutions0773e558-2f46-494c-888a-3bc517202b652024-11-08WarningsExact identifier
application number: M018
Clear Eyes Triple ReliefPOLYVINYL ALCOHOL AND POVIDONE AND TETRAHYDROZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.1269a1a6-843d-4d08-bb3c-c1f3d2e7080d2024-10-25WarningsExact identifier
application number: M018
Clear Eyes Cooling Redness ReliefGLYCERIN AND NAPHAZOLINE HYDROCHLORIDEPrestige Brands Holdings, Inc.38d14e99-e4c8-431b-b106-578eeb38bf3c2024-10-25WarningsExact identifier
application number: M018
EyS Eye WashWATEREyes-Plus LLC1443f6bf-3a77-4a19-8585-0ec58efe042f2024-10-15WarningsExact identifier
application number: M018
Eye WashWATER SOLUTIONKroger Company354402ad-581d-47e7-9fd3-933bef281ff42024-10-11WarningsExact identifier
application number: M018

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