Home NDC 11344-831 Mineral Oil
Product NDC 11344-831
11-digit product format 113440831
Labeler code 11344
Product ID 11344-831_5c13904a-5e3e-0a09-e063-6294a90a44ca
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form OIL
Route ORAL
Labeler Nice-Pak Products, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-04-30
Substance MINERAL OIL
Active strength 999 mg/mL
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 999 mg/mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 11344-831-43 Mineral Oil 473 mL in 1 BOTTLE, PLASTIC OIL 473 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 11344-831 MINERAL OIL OIL [CONSUMER PRODUCT PARTNERS, LLC] 2 Current NDC, 1 package rows 20250323_3780aee2-7018-4c65-8991-be4e98b7339e.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 11344-831-43 11344083143 473 mL in 1 BOTTLE, PLASTIC (11344-831-43) 473 ml 2024-04-30 No No Current