Home NDC 36800-931 Mineral Oil
Product NDC 36800-931
11-digit product format 368000931
Labeler code 36800
Product ID 36800-931_4ab9c8b7-a428-85ea-e063-6394a90a8b73
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form LIQUID
Route ORAL; TOPICAL
Labeler Topco Associates LLC
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2004-12-22
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
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 705909 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 36800-931-43 Mineral Oil 473 mL in 1 BOTTLE, PLASTIC LIQUID 473 12
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-931 MINERAL OIL LIQUID [TOPCO ASSOCIATES] 10 Current NDC, Legacy NDC, 1 package rows 20240802_e9b1fd61-c229-4529-82c2-d6ac5b076082.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 36800-931-43 36800093143 473 mL in 1 BOTTLE, PLASTIC (36800-931-43) 473 ml 2004-12-22 0000-00-00 No No Current