Home NDC 36800-334 Mineral Oil
Product NDC 36800-334
11-digit product format 368000334
Labeler code 36800
Product ID 36800-334_b3d9996c-e3e5-432a-a4bb-32c7fb2aeaad
Type HUMAN OTC DRUG
Nonproprietary name Mineral Oil
Dosage form OIL
Route ORAL; TOPICAL
Labeler TOP CARE (Topco Associates LLC)
Application M007
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-30
Marketing end 2027-12-28
Substance MINERAL OIL
Active strength 100 mg/100mL
NDC exclude flag No
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 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 100 mg/100mL
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 36800-334-16 Mineral Oil 473 mL in 1 BOTTLE, PLASTIC OIL 473 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 36800-334 MINERAL OIL OIL [TOP CARE (TOPCO ASSOCIATES LLC)] 8 Current NDC, Legacy NDC, 1 package rows 20250426_0dd5380e-9671-4a2b-a2ce-6477503d06d2.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 17 of 42 · 833 matching rows.
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 36800-334-16 36800033416 473 mL in 1 BOTTLE, PLASTIC (36800-334-16) 473 ml 2016-11-30 2027-12-28 No No Current