Home NDC 81033-042 Mineral Oil
Product NDC 81033-042
11-digit product format 810330042
Labeler code 81033
Product ID 81033-042_30a11cc9-e408-23b7-e063-6294a90a7d6e
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form SOLUTION
Route ORAL
Labeler Kesin Pharma Corporation
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-03-01
Substance MINERAL OIL
Active strength 1000 mg/mL
NDC exclude flag No
Listing certified through 2026-12-31
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 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 1000 mg/mL
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 RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 343017 Internal RxNorm 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 81033-042-30 Mineral Oil 30 mL in 1 CUP, UNIT-DOSE SOLUTION 30 1 81033-042-50 Mineral Oil 50 in 1 CARTON SOLUTION 50 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 81033-042 MINERAL OIL SOLUTION [KESIN PHARMA CORPORATION] 1 Current NDC, 2 package rows 20250321_30a11cc9-e407-23b7-e063-6294a90a7d6e.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 81033-042-30 81033004230 30 mL in 1 CUP, UNIT-DOSE 30 ml Historical 81033-042-50 81033004250 50 CUP, UNIT-DOSE in 1 CARTON (81033-042-50) / 30 mL in 1 CUP, UNIT-DOSE (81033-042-30) 2025-03-01 No No Current