Home NDC 82645-906 Mineral Oil Heavy
Product NDC 82645-906
11-digit product format 826450906
Labeler code 82645
Product ID 82645-906_0d1cde4b-4304-9c0b-e063-6394a90ac843
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form LIQUID
Route ORAL
Labeler Pharma Nobis, LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2018-12-18
Substance MINERAL OIL
Active strength 1000 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 Heavy
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 311714 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 82645-906-16 Mineral Oil Heavy 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 2 82645-906-32 Mineral Oil Heavy 950 mL in 1 BOTTLE, PLASTIC LIQUID 950 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 82645-906 MINERAL OIL HEAVY (MINERAL OIL) LIQUID [PHARMA NOBIS, LLC] 2 Current NDC, Legacy NDC, 2 package rows 20231223_e42f6c6d-c4de-02c6-e053-2995a90a3ace.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 30 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 Marketing end Sample Exclude flag Status 82645-906-16 82645090616 473 mL in 1 BOTTLE, PLASTIC (82645-906-16) 473 ml 2018-12-18 0000-00-00 No No Current 82645-906-32 82645090632 950 mL in 1 BOTTLE, PLASTIC (82645-906-32) 950 ml 2020-01-31 0000-00-00 No No Current