Home NDC 24208-313 Soothe Night Time
Product NDC 24208-313
11-digit product format 242080313
Labeler code 24208
Product ID 24208-313_22e15dc4-1977-7228-e063-6394a90a679a
Type HUMAN OTC DRUG
Nonproprietary name white petrolatum mineral oil
Dosage form OINTMENT
Route OPHTHALMIC
Labeler Bausch & Lomb Incorporated
Application M018
Marketing category OTC MONOGRAPH DRUG
Marketing start 2011-11-15
Substance MINERAL OIL; PETROLATUM
Active strength 200; 800 mg/g; mg/g
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 24208-313 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 24208-313 24208-313-34 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Soothe Night Time
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MINERAL OIL 200 mg/g PETROLATUM 800 mg/g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination T5L8T28FGP Internal UNII lookup 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 259196 Internal RxNorm lookup 1235262 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 24208-313-34 Soothe Night Time 3.5 g in 1 TUBE OINTMENT 3.5 8
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 24208-313 SOOTHE NIGHT TIME (WHITE PETROLATUM MINERAL OIL) OINTMENT [BAUSCH & LOMB INCORPORATED] 8 Current NDC, Legacy NDC, 1 package rows 20240927_638d3c3f-9960-43da-956e-0e28c77f533e.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 6 of 25 · 494 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 24208-313-34 24208031334 3.5 g in 1 TUBE (24208-313-34) 3.5 g 2011-11-15 0000-00-00 No No Current