retaine PM

Product NDC
54799-893
11-digit product format
547990893
Labeler code
54799
Product ID
54799-893_46f4eba4-1e03-4693-9c44-d5e98b982f6e
Type
HUMAN OTC DRUG
Nonproprietary name
Mineral Oil, White petrolatum
Dosage form
OINTMENT
Route
OPHTHALMIC
Labeler
OCuSOFT LLC
Application
M018
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-09-02
Substance
MINERAL OIL; PETROLATUM
Active strength
200; 800 mg/g; mg/g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
retaine PM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
MINERAL OIL200 mg/g
PETROLATUM800 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
259196Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
ac75e5c9-94ae-698d-40da-dffe4458a098Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54799-893-05retaine PM5 g in 1 TUBEOINTMENT59

DailyMed Socrata Ingredients#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54799-893RETAINE PM (MINERAL OIL, WHITE PETROLATUM) OINTMENT [OCUSOFT, INC.]7Current NDC, Legacy NDC, 1 package rows20240411_ac75e5c9-94ae-698d-40da-dffe4458a098.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 6 of 25 · 494 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OptaseGLYCERINScope Health Incd81c1a4f-87b0-ee8c-e053-2995a90af9e52026-01-30WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Incf452a2c4-c869-7bf5-e053-2995a90ac1a02026-01-30WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITE XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.47ab9609-4291-30b2-e063-6394a90a421e2026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONAL STRENGTH XLGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, L.L.C.48d6dc98-66e8-b499-e063-6394a90ae9352026-01-29WarningsExact identifier
application number: M018
OptaseGLYCERINScope Health Inc86c14327-ffc7-806e-e053-2991aa0aaf922026-01-29WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution PROFESSIONALGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC49771efa-6682-51d0-e063-6294a90a18a52026-01-28WarningsExact identifier
application number: M018
Regener-Eyes Ophthalmic Solution LITEGLYCERIN OPHTHALMIC SOLUTIONM & M PRODUCTS, LLC497763ee-dc70-bb48-e063-6294a90afb3d2026-01-28WarningsExact identifier
application number: M018
Aurovisc Lubricant HYPROMELLOSE 2208 (15000 MPA.S) Gel/DropsHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolabf27a6799-e2f1-ee8d-e053-2a95a90aead12026-01-27WarningsExact identifier
application number: M018
Carboxymethylcellulose Sodium Eye Drops 0.5%CARBOXYMETHYLCELLULOSE SODIUM EYE DROPS 0.5%Aurolabe8b4df3b-3d81-b3ca-e053-2a95a90af2ec2026-01-27WarningsExact identifier
application number: M018
Aurovisc OEHYPROMELLOSE OPHTHALMIC SOLUTION 2% W/VAurolab3142c6df-77ac-ec41-e063-6294a90aee472026-01-27WarningsExact identifier
application number: M018
AURO-CMCCARBOXYMETHYLCELLULOSE EYE DROPS 0.5%Aurolabe90b397f-fe64-8674-e053-2995a90a223f2026-01-27WarningsExact identifier
application number: M018
Optase AllegroHYDROXYETHYL CELLULOSEScope Health Incf7999928-f5c1-98d6-e053-6294a90a57db2026-01-27WarningsExact identifier
application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 5ctCARBOXYMETHYLCELLULOSE SODIUMUnited Exchange Corp48879feb-b5ae-a9e6-e063-6394a90a03b22026-01-16WarningsExact identifier
application number: M018
Family Care Single Use Lubricant Eye Drop 0.4mL 30ctCARBOXYMETHYL CELLULOSE 0.5%United Exchange Corp488b3363-8d06-7dcc-e063-6294a90ab44c2026-01-16WarningsExact identifier
application number: M018
retaine PMMINERAL OIL, WHITE PETROLATUMOCuSOFT LLCac75e5c9-94ae-698d-40da-dffe4458a0982026-01-15WarningsExact identifier
application number: M018
ndc (product): 54799-893
Sodium Chloride HypertonicitySODIUM CHLORIDECVS Pharmacy9245d842-7f78-42d8-83ba-8eb9ec8dbc0d2026-01-15WarningsExact identifier
application number: M018
Sodium Chloride HypertonicitySODIUM CHLORIDECVS PHARMACYd5cc6cd1-ddf8-4f5b-a021-204cdda0db942026-01-15WarningsExact identifier
application number: M018
retaine MGDMINERAL OILOCuSOFT LLC06f57d46-96c7-4093-84aa-874ff4b2131d2026-01-15WarningsExact identifier
application number: M018
Walgreens Sterile Soothing Eye WashPURIFIED WATERWalgreensa62e3294-abd6-48dc-81b1-62a809bdc9682026-01-14WarningsExact identifier
application number: M018
Vis Guard Lubricant EyeOintment PMMINERAL OIL, WHITE PETROLATUM OINTMENTUlai Health LLC1040a92b-d342-a9fd-e063-6294a90a45ef2026-01-13WarningsExact identifier
application number: M018

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
259196mineral oil 20 % / petrolatum 80 % Ophthalmic OintmentPSNac75e5c9-94ae-698d-40da-dffe4458a0989
259196mineral oil 0.2 MG/MG / petrolatum 0.8 MG/MG Ophthalmic OintmentSCDac75e5c9-94ae-698d-40da-dffe4458a0989
259196mineral oil 20 % / petrolatum 80 % Ophthalmic OintmentSYac75e5c9-94ae-698d-40da-dffe4458a0989

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
54799-893-05547990893055 g in 1 TUBE (54799-893-05) 5 g2013-09-020000-00-00NoNoCurrent