Home NDC 0395-1685 Humco Mineral Oil Heavy
Product NDC 0395-1685
11-digit product format 003951685
Labeler code 0395
Product ID 0395-1685_0c93390b-bca4-9c43-e063-6294a90aeffb
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form LIQUID
Route ORAL
Labeler Humco Holding Group, Inc.
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 1998-03-25
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 Humco 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 0395-1685-28 Humco Mineral Oil Heavy 3800 mL in 1 BOTTLE, PLASTIC LIQUID 3800 5
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 0395-1685 HUMCO MINERAL OIL HEAVY (MINERAL OIL) LIQUID [HUMCO HOLDING GROUP, INC.] 5 Current NDC, Legacy NDC, 1 package rows 20231216_9f943fdf-5058-4e18-ba96-6be112bf72ca.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 Marketing end Sample Exclude flag Status 0395-1685-28 00395168528 3800 mL in 1 BOTTLE, PLASTIC (0395-1685-28) 3800 ml 2017-11-14 0000-00-00 No No Current