Home NDC 10967-675 EIGHT HOUR NIGHT
Product NDC 10967-675
11-digit product format 109670675
Labeler code 10967
Product ID 10967-675_0ec6d442-3cb3-709b-e063-6394a90a795d
Type HUMAN OTC DRUG
Nonproprietary name DIMETHICONE
Dosage form EMULSION
Route TOPICAL
Labeler REVLON
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-10-20
Substance DIMETHICONE
Active strength 2 mg/g
Pharmacologic classes Skin Barrier Activity [PE]
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 EIGHT HOUR NIGHT
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength DIMETHICONE 2 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 92RU3N3Y1O Internal UNII lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 10967-675-16 EIGHT HOUR NIGHT 45 g in 1 JAR EMULSION 45 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 10967-675 EIGHT HOUR NIGHT (DIMETHICONE) EMULSION [REVLON] 3 Current NDC, Legacy NDC, 1 package rows 20240113_b3b277f9-565a-636c-e053-2995a90a94d2.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 28 of 68 · 1,357 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 10967-675-16 10967067516 45 g in 1 JAR (10967-675-16) 45 g 2020-10-20 0000-00-00 No No Current