Home NDC 65197-401 AD PREVENT Original
Product NDC 65197-401
11-digit product format 651970401
Labeler code 65197
Product ID 65197-401_d45682ea-98dd-4a57-8f58-c6ccadc01dc9
Type HUMAN OTC DRUG
Nonproprietary name AD PREVENT Original
Dosage form OINTMENT
Route TOPICAL
Labeler WellSpring Pharmaceutical Corporation
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-10-02
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 PREVENT Original
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 65197-401-00 AD PREVENT Original 454 g in 1 JAR OINTMENT 454 6 65197-401-01 AD PREVENT Original 113 g in 1 TUBE OINTMENT 113 6 65197-401-01 AD PREVENT Original 1 in 1 BOX OINTMENT 1 6 65197-401-12 AD PREVENT Original 42.5 g in 1 TUBE OINTMENT 42.5 6 65197-401-12 AD PREVENT Original 1 in 1 BOX OINTMENT 1 6 65197-401-99 AD PREVENT Original 567 g in 1 CARTON OINTMENT 567 6
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 65197-401 AD PREVENT ORIGINAL OINTMENT [WELLSPRING PHARMACEUTICAL CORPORATION] 5 Current NDC, 6 package rows 20250110_cf73246e-81c1-42e9-a107-dc6c99cf7d01.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.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 65197-401-00 65197040100 454 g in 1 JAR (65197-401-00) 454 g 2023-11-01 No No Current 65197-401-01 65197040101 1 TUBE in 1 BOX (65197-401-01) / 113 g in 1 TUBE 1 tube 2023-10-02 No No Current 65197-401-12 65197040112 1 TUBE in 1 BOX (65197-401-12) / 42.5 g in 1 TUBE 1 tube 2023-10-02 No No Current 65197-401-99 65197040199 567 g in 1 CARTON (65197-401-99) 567 g 2025-07-01 No No Current