Home NDC 54799-917 retaine MGD
Product NDC 54799-917
11-digit product format 547990917
Labeler code 54799
Product ID 54799-917_e5019f11-7124-4184-8481-8a1977cd186e
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form EMULSION
Route OPHTHALMIC
Labeler OCuSOFT LLC
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2012-01-05
Substance LIGHT MINERAL OIL; MINERAL OIL
Active strength 2; 2 mg/.4mL; mg/.4mL
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 MGD
Listing expiration 2027-12-31
Active Ingredients# Ingredient, Strength table Ingredient Strength LIGHT MINERAL OIL 2 mg/.4mL MINERAL OIL 2 mg/.4mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination N6K5787QVP Internal UNII lookup T5L8T28FGP Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1236277 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 54799-917-30 retaine MGD 30 in 1 CONTAINER EMULSION 30 8 54799-917-30 retaine MGD 0.4 mL in 1 VIAL, SINGLE-DOSE EMULSION 0.4 8
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded LIGHT MINERAL OIL ACTIVE INGREDIENT N6K5787QVP RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 MINERAL OIL ACTIVE INGREDIENT T5L8T28FGP RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 LIGHT MINERAL OIL ACTIVE MOIETY N6K5787QVP RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 MINERAL OIL ACTIVE MOIETY T5L8T28FGP RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 CETALKONIUM CHLORIDE INACTIVE INGREDIENT 85474O1N9D RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 GLYCERIN INACTIVE INGREDIENT PDC6A3C0OX RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 POLOXAMER 188 INACTIVE INGREDIENT LQA7B6G8JG RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 TROMETHAMINE INACTIVE INGREDIENT 023C2WHX2V RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 TROMETHAMINE HYDROCHLORIDE INACTIVE INGREDIENT 383V75M34E RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 TYLOXAPOL INACTIVE INGREDIENT Y27PUL9H56 RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3 WATER INACTIVE INGREDIENT 059QF0KO0R RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 54799-917 RETAINE MGD (MINERAL OIL) EMULSION [OCUSOFT, INC.] 6 Current NDC, Legacy NDC, 2 package rows 20240806_06f57d46-96c7-4093-84aa-874ff4b2131d.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 · 486 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 54799-917-30 54799091730 30 VIAL, SINGLE-DOSE in 1 CONTAINER (54799-917-30) / .4 mL in 1 VIAL, SINGLE-DOSE 2012-01-05 0000-00-00 No No Current