Home NDC 49580-0334 Mineral oil
Product NDC 49580-0334
11-digit product format 495800334
Labeler code 49580
Product ID 49580-0334_6651c0e4-d583-401d-96c4-5cb5fe10bd97
Type HUMAN OTC DRUG
Nonproprietary name Mineral oil
Dosage form OIL
Route ORAL
Labeler P & L Development, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2014-08-31
Substance MINERAL OIL
Active strength 100 mg/100mL
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 Mineral oil
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 100 mg/100mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 49580-0334-6 Mineral oil 473 mL in 1 BOTTLE OIL 473 6
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 49580-0334 MINERAL OIL OIL [P & L DEVELOPMENT, LLC] 6 Current NDC, Legacy NDC, 1 package rows 20250224_68e88119-1468-4ab7-a5fa-242d960d25df.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 14 of 42 · 833 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 49580-0334-6 49580033406 473 mL in 1 BOTTLE (49580-0334-6) 473 ml 2014-08-31 0000-00-00 No No Current