Home NDC 53329-768 Medline
Product NDC 53329-768
11-digit product format 533290768
Labeler code 53329
Product ID 53329-768_41349255-e0cd-8d71-e063-6394a90a32ca
Type HUMAN OTC DRUG
Nonproprietary name zinc oxide
Dosage form SPRAY
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2023-12-01
Substance ZINC OXIDE
Active strength 250 mg/mL
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 Medline
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ZINC OXIDE 250 mg/mL
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination SOI2LOH54Z Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 865073 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 53329-768-55 Medline 59 mL in 1 BOTTLE, SPRAY SPRAY 59 3
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-768 MEDLINE (ZINC OXIDE) SPRAY [MEDLINE INDUSTRIES, LP] 2 Current NDC, 1 package rows 20241027_dae45414-7401-9536-e053-2a95a90a0a86.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 61 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join ChapStick Classic Spearmint PETROLATUM Haleon US Holdings LLC d39786e8-bcd8-479d-8990-142a21788a47 2024-04-12 Warnings Exact identifier application number: M016 Chapstick 12 Days of Christmas WHITE PETROLATUM Haleon US Holdings LLC d6eb2ea6-27c7-40a6-a1f0-789ea2131de3 2024-04-11 Warnings Exact identifier application number: M016 Chapstick Active 2in1 Variety Pack ZINC OXIDE Haleon US Holdings LLC d1998a9e-d61f-4b4c-91b0-5e66754bcc4a 2024-04-11 Warnings Exact identifier application number: M016 Chapstick 12 Days of Christmas WHITE PETROLATUM Haleon US Holdings LLC 040694f0-b5ba-4203-bde9-699fa9b1afef 2024-04-11 Warnings Exact identifier application number: M016 Chapstick Holiday Classics Kit WHITE PETROLATUM Haleon US Holdings LLC 6df216dc-c03d-463a-8029-5e54c1dc3d27 2024-04-11 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated SPF15 Triple Force Formula OCTINOXATE, OXYBENZONE, WHITE PETROLATUM Carma Laboratories, Inc. 3eb0f8ff-89e7-4410-8573-3349e4946548 2024-04-02 Warnings Exact identifier application number: M016 Pure Cornstarch Baby CORN STARCH Walgreen Company d0e9bd13-b568-4f7e-b036-8d23e71ad8bf 2024-03-25 Warnings Exact identifier application number: M016 ChapStick Supreme Classic Cherry WHITE PETROLATUM Haleon US Holdings LLC 84d8cc38-83e3-49be-b180-d01820525b60 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Moisturizer Original AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM Haleon US Holdings LLC 9cd13fbb-887f-46a8-9f0b-4450ad3e07b7 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Peachy Keen ZINC OXIDE Haleon US Holdings LLC ef206fe7-2659-41dc-b117-380af704999b 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Pretty in Pink ZINC OXIDE Haleon US Holdings LLC e686ce23-57bc-4026-be62-d46d90ded442 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Total Hydration Moisture Tint Very Berry ZINC OXIDE Haleon US Holdings LLC 59023150-65ef-4427-9045-0e64b100cbab 2024-03-22 Warnings Exact identifier application number: M016 Chapstick Moisturizer Cool Mint AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC 33497c07-ad6e-4c50-bc23-a55725b2eae1 2024-03-21 Warnings Exact identifier application number: M016 Chapstick Moisturizer Original AVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUM Haleon US Holdings LLC de250ae9-6e4a-46ca-bcc9-5bb07dbb70c5 2024-03-21 Warnings Exact identifier application number: M016 ChapStick Classic Strawberry WHITE PETROLATUM Haleon US Holdings LLC 3a279496-74c5-4ab1-ba69-06ad4a4f67cf 2024-03-21 Warnings Exact identifier application number: M016 Chapstick Moisturizer Cool Mint AVOBENZONE, OCTINOXATE, AND WHITE PETROLATUM Haleon US Holdings LLC c1120c7a-1fa8-45a4-8bcf-35d9cc9f2c74 2024-03-21 Warnings Exact identifier application number: M016 terrasil Diabetics Ulcer and Sore Relief Kit ALLANTOIN Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions 523b6598-8039-4116-b0f8-ba31d7d6ea9d 2024-03-20 Warnings Exact identifier application number: M016 ChapStick Classic Cherry WHITE PETROLATUM Haleon US Holdings LLC db041b1b-084a-4283-b6ba-4d4bcdc220b3 2024-03-19 Warnings Exact identifier application number: M016 ChapStick Classic Original WHITE PETROLATUM Haleon US Holdings LLC 42fe0f4a-efb7-4e70-a359-db7dc2ac9905 2024-03-19 Warnings Exact identifier application number: M016 ChapStick Classic Spearmint WHITE PETROLATUM Haleon US Holdings LLC 74354d8e-c265-4a27-9715-1a4c157ad890 2024-03-19 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 53329-768-55 53329076855 59 mL in 1 BOTTLE, SPRAY (53329-768-55) 59 ml 2023-12-01 No No Current