Home NDC 65197-404 AD Overnight Healing
Product NDC 65197-404
11-digit product format 651970404
Labeler code 65197
Product ID 65197-404_37c5ce0d-9cc9-4aa0-81e1-b9645765845f
Type HUMAN OTC DRUG
Nonproprietary name AD Overnight Healing
Dosage form OINTMENT
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-05-24
Substance PETROLATUM
Active strength 47.2 g/100g
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 AD Overnight Healing
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 47.2 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 2683093 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 65197-404-04 AD Overnight Healing 1 in 1 BOX OINTMENT 1 4 65197-404-04 AD Overnight Healing 102 g in 1 TUBE OINTMENT 102 4 65197-404-15 AD Overnight Healing 431 g in 1 JAR OINTMENT 431 4
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-404 AD OVERNIGHT HEALING OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION] 4 Current NDC, 3 package rows 20250110_57c29db6-da0c-4b28-86c0-6ac1b7122428.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 52 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-404-04 65197040404 1 TUBE in 1 BOX (65197-404-04) / 102 g in 1 TUBE 1 tube 2024-05-24 No No Current 65197-404-15 65197040415 431 g in 1 JAR (65197-404-15) 431 g 2024-11-15 No No Current