Home NDC 53329-067 Soothe and Cool
Product NDC 53329-067
11-digit product format 533290067
Labeler code 53329
Product ID 53329-067_efceb3a5-8762-fb96-e053-2995a90a1c8f
Type HUMAN OTC DRUG
Nonproprietary name White Petrolatum
Dosage form OINTMENT
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH FINAL
Marketing start 2007-01-01
Marketing end 0000-00-00
Substance PETROLATUM
Active strength 935 mg/g
NDC exclude flag No
Listing certified through 2023-12-31
Current FDA listing Historical FDA.report record Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 22 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Package NDC Code Status Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53329-067-04 D Discontinued by firm d630ba8d3edf…732f749b63fb…2025-08-27 00:01 UTC · source 2025-08-26 excluded product product I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-08-27 00:01 UTC · source 2025-08-26 excluded package package 53329-067-04 I Inactivated by FDA f5e01cc5f278…a2eaf40c39c3…2025-04-01 02:39 UTC · source 2025-03-31 excluded product product I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-04-01 02:39 UTC · source 2025-03-31 excluded package package 53329-067-04 I Inactivated by FDA 2ef7874e63bc…57b86245f4fa…2025-03-28 20:22 UTC · source 2025-03-28 excluded product product I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-28 20:22 UTC · source 2025-03-28 excluded package package 53329-067-04 I Inactivated by FDA a1b67e2a42f9…c4cf2c586c0d…2025-03-22 03:12 UTC · source 2025-03-21 excluded product product I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-22 03:12 UTC · source 2025-03-21 excluded package package 53329-067-04 I Inactivated by FDA cfe11265f3b6…090c488252e2…2025-03-10 12:48 UTC · source 2025-03-10 excluded product product I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-03-10 12:48 UTC · source 2025-03-10 excluded package package 53329-067-04 I Inactivated by FDA cdf11ea48f46…ba0047e9e063…2025-02-02 03:52 UTC · source 2025-01-31 excluded product product I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-02-02 03:52 UTC · source 2025-01-31 excluded package package 53329-067-04 I Inactivated by FDA 302b2466d912…e7b80fea0513…2025-01-20 13:05 UTC · source 2025-01-20 excluded product product I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-20 13:05 UTC · source 2025-01-20 excluded package package 53329-067-04 I Inactivated by FDA ed331223b511…672a5bd82f5f…2025-01-11 03:41 UTC · source 2025-01-10 excluded product product I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2025-01-11 03:41 UTC · source 2025-01-10 excluded package package 53329-067-04 I Inactivated by FDA 0efc9e666f02…f202fb6c5f17…2024-11-09 02:27 UTC · source 2024-11-08 excluded product product I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-11-09 02:27 UTC · source 2024-11-08 excluded package package 53329-067-04 I Inactivated by FDA ad56d346431e…cc804d4bbf1e…2024-10-04 04:10 UTC · source 2024-10-03 excluded product product I Inactivated by FDA 367a005e9d99…383a685ebd0f…2024-10-04 04:10 UTC · source 2024-10-03 excluded package package 53329-067-04 I Inactivated by FDA 367a005e9d99…383a685ebd0f…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Product Concepts# FDA-Initiated Inactive NDC Indexing# DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-067 SOOTHE AND COOL (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP] 6 Legacy NDC 20221217_405163d3-c61d-4481-999a-b17ec33589d6.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 65 of 68 · 1,343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 0bc6812a-5c2a-7bb9-e063-6294a90a36e3 2023-12-05 Warnings Exact identifier application number: M016 Carmex Classic Lip Balm Medicated Free Strawberry Stick Sunscreen SPF 15 CAMPHOR (SYNTHETIC), WHITE PETROLATUM, OCTINOXATE, OXYBENZONE Carma Laboratories, Inc. 34fae56e-367d-4659-af2d-1c9ddaf1639c 2023-12-05 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE Rejoice International Corp. 0ba98cdf-489e-dc2a-e063-6294a90adb38 2023-12-04 Warnings Exact identifier application number: M016 Diaper Rash Cream 2.5oz ZINC OXIDE China Ningbo Shangge Cosmetics Technology Corp. 0baa8a14-8655-d77c-e063-6294a90ab8aa 2023-12-04 Warnings Exact identifier application number: M016 THERAPLEX Eczema Therapy OATMEAL THERAPLEX, LLC 86472a3d-7138-4141-8422-ab20c17a46e0 2023-12-04 Warnings Exact identifier application number: M016 SOOTHE Moisturizing Rescue Cream OATMEAL Rodan & Fields 91163267-c2aa-47b3-b290-d1605536d806 2023-12-04 Warnings Exact identifier application number: M016 Manzatin-E Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. cafd084f-8493-4d6e-b256-2d4b4282f866 2023-12-01 Warnings Exact identifier application number: M016 Manzatin Diaper Rash Skin Protectant ZINC OXIDE Laboratorios Zepol S.A. 5c1618a4-ca08-4814-a556-74e79db618b9 2023-12-01 Warnings Exact identifier application number: M016 Petrolatum Jelly PETROLATUM NEW PRIDE CORP f6634410-fa1f-7987-e053-2995a90abb06 2023-12-01 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair Balm DIMETHICONE Galderma Laboratories, L.P. 5efb3ef0-6ee9-4ef8-b81e-90bd1825c956 2023-11-30 Warnings Exact identifier application number: M016 Cetaphil Cracked Skin Repair DIMETHICONE Galderma Laboratories, L.P. 27d74e0f-8359-4c59-bf7f-acade7f4545c 2023-11-30 Warnings Exact identifier application number: M016 Sheffield Advanced Scar Gel ADVANCED SCAR GEL Sheffield Pharmaceuticals LLC ab78b946-81ed-442c-a167-26c26c7fe8a1 2023-11-30 Warnings Exact identifier application number: M016 Akin Diaper Rash ZINC OXIDE Southern Sales & Service, Inc. f5515517-7977-48f9-aab6-cf0d2f2a04a0 2023-11-29 Warnings Exact identifier application number: M016 Dr. Sheffield Diaper Rash ZINC OXIDE Sheffield Pharmaceuticals LLC cac77320-b5cf-4edf-9693-ebabfb61390c 2023-11-28 Warnings Exact identifier application number: M016 Sheffield Zinc Oxide ZINC OXIDE Sheffield Pharmaceuticals LLC 60b54c04-4387-4954-951d-165809947310 2023-11-28 Warnings Exact identifier application number: M016 Cetaphil Baby Soothe and Protect Cream ALLANTOIN Galderma Laboratories, L.P. 38254e03-3716-4e45-86b7-06430ebadc86 2023-11-22 Warnings Exact identifier application number: M016 Cetaphil Baby Eczema Soothing COLLOIDAL OATMEAL Galderma Laboratories, L.P. d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b 2023-11-22 Warnings Exact identifier application number: M016 EczemaHoneyBodyLotion COLLOIDAL OATMEAL Allure Labs 0a710be0-562e-8368-e063-6294a90a3b1b 2023-11-18 Warnings Exact identifier application number: M016 Zinc Oxide SKIN PROTECTANT BluePoint Laboratories d9b752e6-655a-19a6-e053-2995a90a9a37 2023-11-17 Warnings Exact identifier application number: M016 UNIVERSAL ORIGINAL PETROLEUM WHITE PETROLEUM Universal Distribution Center LLC 47b8c720-ad1e-4ac7-ba73-872e409b38bf 2023-11-17 Warnings Exact identifier application number: M016
Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 53329-067-04 53329006704 113 g in 1 TUBE (53329-067-04) 113 g 2007-01-01 0000-00-00 No No Current