Home NDC 53329-071 Soothe and Cool Moisture Barrier
Product NDC 53329-071
11-digit product format 533290071
Labeler code 53329
Product ID 53329-071_e9b0b9fd-5057-7b6b-e053-2995a90a9d71
Type HUMAN OTC DRUG
Nonproprietary name Petrolatum
Dosage form OINTMENT
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH FINAL
Marketing start 2006-03-01
Marketing end 0000-00-00
Substance PETROLATUM
Active strength 98 g/100g
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 · 5 matching rows.
View current auxiliary records. · View the auxiliary file history.
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# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded PETROLATUM ACTIVE INGREDIENT 4T6H12BN9U SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 PETROLATUM ACTIVE MOIETY 4T6H12BN9U SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 .ALPHA.-TOCOPHEROL ACETATE, D- INACTIVE INGREDIENT A7E6112E4N SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 ALOE INACTIVE INGREDIENT V5VD430YW9 SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 BENZETHONIUM CHLORIDE INACTIVE INGREDIENT PH41D05744 SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 CHOLECALCIFEROL INACTIVE INGREDIENT 1C6V77QF41 SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 CORN OIL INACTIVE INGREDIENT 8470G57WFM SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1 VITAMIN A PALMITATE INACTIVE INGREDIENT 1D1K0N0VVC SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.] 1
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-071 SOOTHE AND COOL MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP] 9 Legacy NDC 20241127_59625382-2769-4c91-9c53-e19dfd6ca115.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 50 of 68 · 1,357 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Shea Butter Petroleum Jelly PETROLATUM JELLY Walgreens e35d913e-2195-4e3d-ae38-f010317140fd 2024-12-17 Warnings Exact identifier application number: M016 Jell Pharmaceuticals Vitamin A D PETROLATUM Jell Pharmaceuticals Pvt. Ltd. 6ab8ba54-3679-4fd0-a876-cb89aace96ca 2024-12-17 Warnings Exact identifier application number: M016 Shea Butter Petroleum Jelly PETROLATUM JELLY Jell Pharmaceuticals Pvt. Ltd. cd848f33-e863-d3af-e053-2a95a90a45b1 2024-12-17 Warnings Exact identifier application number: M016 Softlips Cherry, Raspberry, Vanilla DIMETHICONE The Mentholatum Company b7b2f64e-27b4-4c71-95cf-78b37540f975 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut DIMETHICONE The Mentholatum Company 1203ea70-dc1a-4439-a230-bd3fc45f75f5 2024-12-17 Warnings Exact identifier application number: M016 Softlips Tropical Coconut Peach Passion DIMETHICONE The Mentholatum Company 11f619e7-4a58-45e4-8f4a-fe358832ab64 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon, Tropical Coconut, Peach Passion DIMETHICONE The Mentholatum Company e9212502-909a-4184-905e-f31a53602c3b 2024-12-17 Warnings Exact identifier application number: M016 Softlips Watermelon DIMETHICONE The Mentholatum Company e32d738e-e0af-4f17-a753-bdc7938b1684 2024-12-17 Warnings Exact identifier application number: M016 Softlips Peach Passion DIMETHICONE The Mentholatum Company 4a133e73-e51b-4f04-91de-dc8c4d4dba30 2024-12-17 Warnings Exact identifier application number: M016 Sweet Cheeks Diaper ZINC OXIDE Tubby Todd 4ed0afe1-c893-453e-b4d5-f32561360ec1 2024-12-17 Warnings Exact identifier application number: M016 White Petrolatum PETROLATUM Geri-Care Pharmaceuticals, Corp f40a29c2-65ea-91f9-e053-2a95a90ac439 2024-12-17 Warnings Exact identifier application number: M016 Vitamin A and D PETROLATUM Geri-care Pharmaceutials Corp fd76c101-a287-f92c-e053-6294a90a4468 2024-12-17 Warnings Exact identifier application number: M016 Foster and Thrive Phenolated Calamine CALAMINE AND ZINC OXIDE AND PHENOL Strategic Sourcing Services LLC 298171e1-2826-d33b-e063-6394a90a875a 2024-12-17 Warnings Exact identifier application number: M016 Secura Dimethicone Protectant DIMETHICONE Smith & Nephew Medical Ltd 83f92ac9-4114-4192-926d-be2854a84106 2024-12-16 Warnings Exact identifier application number: M016 CVS Maximum Strength Anti-Itch Cream HYDROCORTISONE 1% CVS Health c2876cba-d7e7-de5c-e053-2a95a90a6355 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Lip) DIMETHICONE, OCTINOXATE, OCTISALATE, CAMPHOR (SYNTHETIC), MENTHOL, UNSPECIFIED FORM, AND PHENOL Blistex Inc 4121d671-521c-4f36-b2db-652c13f730c6 2024-12-16 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm Variety Pack (Blistex Medicated Berry Lip Balm, Blistex Medicated Lip Balm, Blistex Medicated Mint Lip Balm) DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 24e1d2fc-3f9d-4e86-a397-61bfbfc4d58c 2024-12-16 Warnings Exact identifier application number: M016 Balmex Diaper Rash ZINC OXIDE 11.3% Randob Labs, LTD f7f7a89d-d4e0-9faa-e053-6294a90aaf7b 2024-12-15 Warnings Exact identifier application number: M016 QC Scar ALLANTOIN 0.5% CDMA f7e3d751-a47a-2bca-e053-6394a90a6541 2024-12-15 Warnings Exact identifier application number: M016 Dr. Butler Soothing Incontinence PETROLATUM 36% Beyond Health P.A. d17a0c28-a5b7-4df0-e053-2995a90a8edd 2024-12-15 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 53329-071-14 53329007114 56 g in 1 TUBE (53329-071-14) 56 g 2019-01-01 0000-00-00 No No Current 53329-071-15 53329007115 198 g in 1 TUBE (53329-071-15) 198 g 2019-01-01 0000-00-00 No No Current 53329-071-16 53329007116 5 g in 1 PACKET (53329-071-16) 5 g 2006-03-01 0000-00-00 No No Current 53329-071-96 53329007196 144 PACKET in 1 BOX (53329-071-96) > 5 g in 1 PACKET (53329-071-16) 144 packet 2006-03-01 0000-00-00 No No Current