Home NDC 50438-401 Royal Petroleum (Vitamin E Enriched)
Product NDC 50438-401
11-digit product format 504380401
Labeler code 50438
Product ID 50438-401_bee0a22f-1615-45d0-bbf5-f30c48b0fe62
Type HUMAN OTC DRUG
Nonproprietary name PETROLATUM
Dosage form JELLY
Route TOPICAL
Labeler Filo America
Application part347
Marketing category OTC MONOGRAPH FINAL
Marketing start 2014-02-19
Marketing end 0000-00-00
Substance PETROLATUM
Active strength 30 g/100g
NDC exclude flag No
Listing certified through 2019-12-31
Current FDA listing Historical FDA.report record NDC auxiliary status# Explicit status records from FDA unfinished, excluded, and compounder auxiliary files. Absence of a row is not itself a regulatory status.
Dataset, Scope, Product NDC table Dataset Scope Product NDC Package NDC Code Status Reporting period Source date excluded product product 50438-401 I Inactivated by FDA 2026-07-31 excluded package package 50438-401 50438-401-01 I Inactivated by FDA 2026-07-31
openFDA label cross-check# Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Astringent CALCIUM ACETATE MONOHYDRATE AND ALUMINUM SULFATE TETRADECAHYDRATE Granulation Technology, Inc. 1c2bf19c-2f32-4a22-a371-16cc744dce76 2025-06-12 Warnings Exact identifier Petrolatum PETROLATUM Greenbrier International, Inc. 91f24a0c-276f-4962-8da8-462b1f42040e 2019-05-17 Warnings Exact identifier Eczema Care Moisturizing 3 oz. COLLOIDAL OATMEAL Rejoice International Inc. 83967d26-159a-e95c-e053-2991aa0af53a 2019-03-08 Warnings Exact identifier Oatmeal Skin Relief Calming . 8oz DIMETHICONE Rejoice International Inc. 8384dc52-ba36-da3d-e053-2a91aa0a4f40 2019-03-07 Warnings Exact identifier Petrolatum PETROLATUM Greenbrier International, Inc. b8832ee7-3e13-456b-b301-dad7473a032b 2019-02-04 Warnings Exact identifier BURTS BEES BABY BEE DIAPER RASH ZINC OXIDE BURT'S BEES, INC. 168b31b1-9260-61f8-e054-00144ff8d46c 2018-12-21 Warnings Exact identifier Balmex Diaper Rash ZINC OXIDE Randob Labs,Ltd. f202dd0e-7c61-4ea1-a5f6-e90898366ba3 2018-11-13 Warnings Exact identifier BALMEX ADULT CARE RASH ZINC OXIDE Randob Labs,Ltd. 9443a987-c7b2-4b0d-a9dc-02233135af81 2018-11-13 Warnings Exact identifier BALMEX MULTI-PURPOSE PETROLATUM Randob Labs,Ltd. 83a9ba1a-b708-47e2-a4a3-ef847e1bb792 2018-11-13 Warnings Exact identifier Natures Choice Vitamins A and D A AND D OINTMENT Unipack, Inc. 17861122-2231-4a54-b3d8-894153c708d7 2018-01-15 Warnings Exact identifier MG217 Eczema Face COLLOIDAL OATMEAL Wisconsin Pharmacal Company 5f10697e-7f0c-f2b7-e053-2991aa0aabde 2017-11-30 Warnings Exact identifier MG217 Baby Eczema COLLOIDAL OATMEAL Wisconsin Pharmacal Company 5d65052d-2972-544d-e053-2a91aa0afa3e 2017-11-28 Warnings Exact identifier Vitamin A and D LANOLIN AND PETROLATUM Family Dollar Services Inc 4826b36d-3326-4f5c-8b22-c5ff79e55062 2017-11-08 Warnings Exact identifier TriCalm Hydrogel ALUMINUM ACETATE Modular Thermal Technologies LLC Dba Life Wear Technologies 5cb42ffb-3655-4c38-bf84-1cf33c82df10 2017-03-23 Warnings Exact identifier CVS Health Diaper Rash ZINC OXIDE CVS Health 12f786a0-0960-4b98-9f0b-dcf3725a9866 2017-03-20 Warnings Exact identifier ARGAN AIR WATER BANG ESSENCE DIMETHICONE Pioom Cosmetic Co.,ltd 34e79668-0710-5753-e054-00144ff88e88 2016-06-08 Warnings Exact identifier
Warnings cross-check# openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
warnings Warnings For external use only When using this product Avoid contact with eyes. If contact occurs, rinse thoroughly with water. Do not cover compress or wet dressing with plastic to prevent evaporation In some skin conditions, soaking too long may overdry Stop use and ask a doctor if condition worsens or symptoms persist for more than 7 days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
FDA-Initiated Inactive NDC Indexing# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50438-401-01 Royal Petroleum (Vitamin E Enriched) 198 g in 1 TUBE JELLY 198 1
DailyMed Socrata Ingredients# DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50438-401 ROYAL PETROLEUM (VITAMIN E ENRICHED) (PETROLATUM) JELLY [FILO AMERICA] 1 Legacy NDC, 1 package rows 20140219_a32070de-5501-46dc-a4d8-61f45d377e78.zip
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Status 50438-401-01 50438040101 198 g in 1 TUBE 198 g Historical