Home NDC 53329-097 Remedy Essentials
Product NDC 53329-097
11-digit product format 533290097
Labeler code 53329
Product ID 53329-097_47a8adf6-e5fd-f0c5-e063-6294a90a9e3d
Type HUMAN OTC DRUG
Nonproprietary name White Petrolatum,Zinc Oxide
Dosage form PASTE
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-11-14
Substance ZINC OXIDE; PETROLATUM
Active strength 20; 75 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 Remedy Essentials
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 20 g/100g PETROLATUM 75 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z 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 1860083 Internal RxNorm 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 53329-097-16 Remedy Essentials 5 g in 1 PACKET PASTE 5 8 53329-097-44 Remedy Essentials 113 g in 1 TUBE PASTE 113 8 53329-097-96 Remedy Essentials 144 in 1 BOX PASTE 144 8 53329-097-96 Remedy Essentials 5 g in 1 PACKET PASTE 5 8
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-097 REMEDY ESSENTIALS (WHITE PETROLATUM,ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP] 6 Current NDC, Legacy NDC, 4 package rows 20240606_42a033d6-782b-2d7f-e054-00144ff8d46c.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 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 Marketing end Sample Exclude flag Status 53329-097-16 53329009716 5 g in 1 PACKET (53329-097-16) 5 g 2024-03-01 No No Current 53329-097-44 53329009744 113 g in 1 TUBE (53329-097-44) 113 g 2016-11-14 0000-00-00 No No Current 53329-097-96 53329009796 144 PACKET in 1 BOX (53329-097-96) / 5 g in 1 PACKET 144 packet 2024-03-01 No No Current