Home NDC 65197-470 AD Skin Protectant
Product NDC 65197-470
11-digit product format 651970470
Labeler code 65197
Product ID 65197-470_45ffedac-d2b6-4783-9c15-ff538ce73a7e
Type HUMAN OTC DRUG
Nonproprietary name AD Skin Protectant
Dosage form OINTMENT
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2025-01-20
Substance LANOLIN; PETROLATUM
Active strength 15.5; 53.4 g/100g; 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 Skin Protectant
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength LANOLIN 15.5 g/100g PETROLATUM 53.4 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 7EV65EAW6H Internal UNII lookup 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 664981 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 65197-470-16 AD Skin Protectant 454 g in 1 JAR OINTMENT 454 5 65197-470-35 AD Skin Protectant 99 g in 1 TUBE OINTMENT 99 5 65197-470-35 AD Skin Protectant 1 in 1 BOX OINTMENT 1 5
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 55 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 65197-470-16 65197047016 454 g in 1 JAR (65197-470-16) 454 g 2025-03-15 No No Current 65197-470-35 65197047035 1 TUBE in 1 BOX (65197-470-35) / 99 g in 1 TUBE 1 tube 2025-01-20 No No Current