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 firm2026-10-16
excluded packagepackage0023-02400023-0240-21DDiscontinued by firm2026-10-16

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 23 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Care Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLBetter Living Brands LLC5d7228ce-f108-4cc2-9aec-8b4548c3a1552023-12-20WarningsExact identifier
application number: M018
Target Eye Drops Maximum Redness Relief EyeGLYCERIN, NAPHAZOLINE HYDROCHLORIDETarget Corporation1b26cd3b-4a05-4623-b320-01f22b3106ff2023-12-20WarningsExact identifier
application number: M018
Kroger High Performance Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLKrogerd2aa8963-1922-02f3-e053-2a95a90a7d932023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Seasonal ReliefTETRAHYDROZOLINE HCL, ZINC SULFATEKrogerf6829be4-e3b7-7ff2-e053-2995a90a80fc2023-12-20WarningsExact identifier
application number: M018
Rite Aid Multi-Symptom Relief Eye DropsPOLYETHYLENE GLYCOL 400, TETRAHYDROZOLINE HCL, ZINC SULFATERite Aid Corporationefa7d208-9d42-13c7-e053-2a95a90a11b32023-12-20WarningsExact identifier
application number: M018
Signature Care Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMBetter Living Brands LLCea358e01-f03e-454b-bae1-6c83da44c3692023-12-20WarningsExact identifier
application number: M018
TopCare Health Original Eye DropsTETRAHYDROZOLINE HCLTopco Associates LLC9c61a56a-c1a9-2846-e053-2995a90a755b2023-12-20WarningsExact identifier
application number: M018
Signature Care Eye Drops A.C.TETRAHYDROZOLINE HCL, ZINC SULFATEBetter Living Brands LLCf685aca4-93d0-26d9-e053-2995a90a6e512023-12-20WarningsExact identifier
application number: M018
Kroger Lubricant EyeCARBOXYMETHYLCELLULOSE SODIUMThe Kroger Co.046f4ebc-d8f9-4755-b6ba-790fe86f31282023-12-20WarningsExact identifier
application number: M018
Kroger Eye Drops Advanced ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEKroger Companyf7ad77fc-d890-25b9-e053-6394a90a2b122023-12-20WarningsExact identifier
application number: M018
TopCare Health Dry Eye Relief Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400Topco Associates LLC9c617e34-fc66-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Equaline Advanced Relief Eye DropsDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HYDROCHLORIDEUnited Natural Foods, Inc.f7602789-179a-edfc-e053-6294a90a08442023-12-20WarningsExact identifier
application number: M018
Topcare Health Ultra Itch Relief Astringent Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATETopco Associates LLC9c617e34-fc64-1a5b-e053-2995a90ace2c2023-12-20WarningsExact identifier
application number: M018
Topcare Health Artificial TearsPOLYVINYL ALCOHOL, POVIDONETopco Associates LLC9c614c0e-5862-682f-e053-2a95a90abc092023-12-20WarningsExact identifier
application number: M018
Topcare Health Lubricant Eye DropsPOLYETHYLENE GLYCOL 400, PROPYLENE GLYCOLTopco Assoc LLC9c6284f9-00bb-37b5-e053-2a95a90ae2ee2023-12-20WarningsExact identifier
application number: M018
HEB Dry Eye Eye DropsGLYCERIN, HYPROMELLOSE, POLYETHYLENE GLYCOL 400HEBf80023cf-8e42-780a-e053-6294a90a66cd2023-12-20WarningsExact identifier
application number: M018
TopCare Health Advanced Moisturizing Plus Redness ReliefDEXTRAN 70, POLYETHYLENE GLYCOL 400, POVIDONE, TETRAHYDROZOLINE HCLTopco Associates LLC9c6193a6-d822-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
Topcare Maximum Redness Relief Eye DropsGLYCERIN, NAPHAZOLINE HYDROCHLORIDETopco Assoc LLC9c6193a6-d824-1b27-e053-2995a90ab3cf2023-12-20WarningsExact identifier
application number: M018
HEB Lubricant Eye DropsCARBOXYMETHYLCELLULOSE SODIUMHEB5d522e4d-d647-486f-a947-25c14b1417fa2023-12-20WarningsExact identifier
application number: M018
HEB A.C. Eye DropsTETRAHYDROZOLINE HCL, ZINC SULFATEHEB Grocery Company., LPf680a8c1-dc91-7a52-e053-2a95a90a571e2023-12-20WarningsExact 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