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 42 of 68 · 1,343 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Witch Hazel WITCH HAZEL TOP CARE (Topco Associates LLC) 23b592f7-3af3-45ef-897a-fe33ab518b6d 2025-04-14 Warnings Exact identifier application number: M016 Witch Hazel WITCH HAZEL Strategic Sourcing Services LLC ef3408db-de98-4a43-9215-f80fed14815c 2025-04-14 Warnings Exact identifier application number: M016 Petroleum Jelly PETROLATUM Walgreens 69bdd508-7c33-42c5-9a08-e56cf3eaebf3 2025-04-11 Warnings Exact identifier application number: M016 4% 10gTATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 322daa32-a74e-1fee-e063-6294a90a37aa 2025-04-07 Warnings Exact identifier application number: M016 Aluroderm Scar ALLANTOIN Asclemed USA, Inc. 60656ca1-5218-4595-854e-19f1061def1e 2025-04-01 Warnings Exact identifier application number: M016 Dr. Maxs Diaper ZINC OXIDE Dr. Maxs LLC 31bfa962-5e3b-c5d2-e063-6294a90ac177 2025-04-01 Warnings Exact identifier application number: M016 Vaseline BABY HEALING JELLY Conopco Inc. d/b/a Unilever bca3176f-86fe-5969-e053-2995a90a2419 2025-03-31 Warnings Exact identifier application number: M016 4% TATTOO Numb Cream 4% LIDOCAINE Shengnan (Guangzhou) Cosmetics Co., LTD 31646815-f591-c560-e063-6294a90ad11a 2025-03-28 Warnings Exact identifier application number: M016 Face Saver Gel SKIN PROTECTANT GEL Neat Feat Products Limited 31563dd7-9f58-80f6-e063-6294a90a5571 2025-03-27 Warnings Exact identifier application number: M016 Porphose COLLOIDAL OATMEAL TOPICAL SPRAY Porphose 315951e0-899f-c968-e063-6294a90abe61 2025-03-27 Warnings Exact identifier application number: M016 Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fc9eecd-fd25-827c-e063-6394a90a26a5 2025-03-26 Warnings Exact identifier application number: M016 Cocoa Butter Petroleum Jelly WHITE PETROLATUM JELLY WALGREENS 1fcc9626-6058-e9b3-e063-6394a90ab525 2025-03-26 Warnings Exact identifier application number: M016 Nicotine Patches NICOTINE PATCHES Zhejiang FTA Shengzuozhi Biotechnology Co., LTD 313b08e2-d764-96da-e063-6294a90ab705 2025-03-25 Warnings Exact identifier application number: M016 Eczema Cream ECZEMA CREAM Kyte Baby LLC 30c943aa-d9dc-5c16-e063-6294a90a3c58 2025-03-20 Warnings Exact identifier application number: M016 Koala Kubs Diaper Rash Cream DIAPER RASH CREAM Melaleuca, Inc. c6b3b0dd-22a8-16f7-e053-2a95a90a51ea 2025-03-20 Warnings Exact identifier application number: M016 Gold Bond Eczema Relief Medicated Skin Protectant Cream COLLOIDAL OATMEAL Chattem, Inc. 2b6b8342-878d-4588-8b24-6746d35d319d 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Juicy Peach COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b20bd5-3b4f-8cc7-e063-6394a90a9106 2025-03-19 Warnings Exact identifier application number: M016 First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Fresh Strawberry COLLOIDAL OATMEAL The Procter & Gamble Manufacturing Company 30b2744d-fb59-f383-e063-6294a90abd2a 2025-03-19 Warnings Exact identifier application number: M016 Dr. Butler Hemorrhoid and Perineal MINERAL OIL 59.8%,PETROLATUM 36% Beyond Health P.A. d17b6f16-6893-ce0a-e053-2a95a90aa23a 2025-03-19 Warnings Exact identifier application number: M016 Gold Bond Diabetics Medicated Dry Skin Relief Foot Cream DIMETHICONE, WHITE PETROLATUM Chattem, Inc. b951d1cb-b81e-4d7f-9a67-8405daa89667 2025-03-19 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