Home NDC 53329-771 Sensi-Care
Product NDC 53329-771
11-digit product format 533290771
Labeler code 53329
Product ID 53329-771_efdff7d9-0155-f285-e053-2a95a90a20d4
Type HUMAN OTC DRUG
Nonproprietary name petrolatum, zinc oxide
Dosage form CREAM
Route TOPICAL
Labeler Medline Industries, LP
Application M016
Marketing category OTC MONOGRAPH FINAL
Marketing start 2020-09-30
Marketing end 0000-00-00
Substance PETROLATUM; ZINC OXIDE
Active strength 49 g/100g; 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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2025-12-14 17:58 UTC · source 2025-12-05 excluded product product 53329-771 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…2025-12-14 17:58 UTC · source 2025-12-05 excluded package package 53329-771 53329-771-44 D Discontinued by firm excluded / ndc_excluded.zip d630ba8d3edf…732f749b63fb…
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 53329-771 SENSI-CARE (PETROLATUM, ZINC OXIDE) CREAM [MEDLINE INDUSTRIES, LP] 5 Legacy NDC 20240704_af5f9d80-9697-edfd-e053-2a95a90a32b4.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 62 of 68 · 1,350 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 5ae6d5d4-caff-4360-a0e7-7c8d7a9b5907 2024-02-28 Warnings Exact identifier application number: M016 XtraCare with cooling action Oatmeal Skin Relief Calmin DIMETHICONE Rejoice International 29abd476-c32d-49f0-b283-30f4ba570ab4 2024-02-28 Warnings Exact identifier application number: M016 MAX BARRIER Skin Protectant ZINC OXIDE GL HEALTH, INC. 5eec834d-d8f3-49e3-b230-f8cf88b795e6 2024-02-26 Warnings Exact identifier application number: M016 Rugby Petrolatum Hydrating Skin Protectant PETROLATUM Rugby Laboratories ad63e345-1fe8-4f9a-a32e-8dfcde31bedc 2024-02-12 Warnings Exact identifier application number: M016 A and D PETROLATUM Safetec of America, Inc. b9afda3a-9e1d-46c1-b7aa-c3143caf709e 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Mint Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 86fc9f3c-e35f-4988-bf19-64d9c6c85ee9 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Berry Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 827365b3-b3a5-4472-9add-f822362c4731 2024-02-09 Warnings Exact identifier application number: M016 Blistex Medicated Lip Balm DIMETHICONE, OCTINOXATE, AND OCTISALATE Blistex Inc 8b4160ed-8889-4e3a-947f-a56c3324dbbe 2024-02-09 Warnings Exact identifier application number: M016 Medline WHITE PETROLATUM, ZINC OXIDE Medline Industries, LP 101b9933-c2b8-0fdd-e063-6294a90a306a 2024-01-29 Warnings Exact identifier application number: M016 XtraCare Skin Relief Oatmeal Daily Moisturizing DIMETHICONE Rejoice International 8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc 2024-01-29 Warnings Exact identifier application number: M016 Cetaphil Baby Healing PETROLATUM Galderma Laboratories, L.P. 5140754e-5db0-470f-adfd-de02b184880b 2024-01-29 Warnings Exact identifier application number: M016 CHAPSTICK CLASSIC MEDICATED CAMPHOR, MENTHOL, PETROLATUM Haleon US Holdings LLC b4259621-ff41-46cc-a658-b57bff3c1525 2024-01-23 Warnings Exact identifier application number: M016 Zinc Oxide 20% ZINC OXIDE Trifecta Pharmaceuticals USA fcef17f1-84e7-a288-e053-6294a90a064b 2024-01-19 Warnings Exact identifier application number: M016 Hydro Gel GLYCERIN 20% Trifecta Pharmaceuticals USA LLC 02e8e5d0-7844-39fe-e063-6394a90a57e1 2024-01-19 Warnings Exact identifier application number: M016 White Petrolatum WHITE PETROLATUM Sled Distribution, LLC e73a4b7a-7b27-abfc-e053-2995a90a35c2 2024-01-15 Warnings Exact identifier application number: M016 Sunmark Caldiphen CALAMINE AND PRAMOXINE HYDROCHLORIDE Strategic Sourcing Services 4f4d4c54-64b5-4e20-bed0-c7fb470b8434 2024-01-12 Warnings Exact identifier application number: M016 EIGHT HOUR NIGHT DIMETHICONE REVLON b3b277f9-565a-636c-e053-2995a90a94d2 2024-01-12 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Eczema Relief Creamy OATMEAL L'Oreal USA Products Inc bcf7b985-6875-4033-a412-1bb6d3afa6d8 2024-01-01 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Healing PETROLATUM L'Oreal USA Products Inc. 1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95 2023-12-31 Warnings Exact identifier application number: M016 CeraVe Developed with Dermatologists Baby Healing PETROLATUM L'Oreal USA Products Inc. fe665bbc-1172-4f59-acc6-8d5c179693b6 2023-12-31 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 53329-771-44 53329077144 113 g in 1 TUBE (53329-771-44) 113 g 2020-09-30 0000-00-00 No No Current