Home NDC 78495-004-01 Princess Petroleum
Product NDC 78495-004
Requested package NDC 78495-004-01
11-digit product format 784950004
Labeler code 78495
Product ID 78495-004_298dabf6-4ce8-7ed2-e063-6394a90a1bdc
Type HUMAN OTC DRUG
Nonproprietary name White Petrolatum
Dosage form JELLY
Route TOPICAL
Labeler Ultra Distributors Inc.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2020-12-01
Substance PETROLATUM
Active strength 100 g/100g
NDC exclude flag No
Listing certified through 2027-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Princess Petroleum
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength PETROLATUM 100 g/100g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 4T6H12BN9U Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 204754 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 78495-004-01 Princess Petroleum 113 g in 1 JAR JELLY 113 2 78495-004-02 Princess Petroleum 170 g in 1 JAR JELLY 170 2 78495-004-03 Princess Petroleum 226 g in 1 JAR JELLY 226 2 78495-004-04 Princess Petroleum 368 g in 1 JAR JELLY 368 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 78495-004 PRINCESS PETROLEUM (WHITE PETROLATUM) JELLY [ULTRA DISTRIBUTORS INC.] 2 Current NDC, Legacy NDC, 4 package rows 20241220_6d9c92bf-9263-40a4-acac-5c3f0b08c69d.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 · 1,346 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join 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 Copperlife Foot DIMETHICONE 1% Tommie Copper, Inc. cb825d2c-6333-3c1f-e053-2995a90a78f3 2024-12-15 Warnings Exact identifier application number: M016 Tommie Copper Foot DIMETHICONE 1% Tommie Copper, Inc. ca3d3374-a3d4-69e5-e053-2995a90a3ece 2024-12-15 Warnings Exact identifier application number: M016 Evereden Healing Eczema Treatment COLLOIDAL OATMEAL Eden Brands, Inc. d43f0eaa-aab0-eaff-e053-2995a90ac5c8 2024-12-13 Warnings Exact identifier application number: M016 Babo Fragrance Free Diaper Cream ZINC OXIDE Babo Botanicals, Inc. adcd4fc7-c400-fc8e-e053-2a95a90a7e1f 2024-12-12 Warnings Exact identifier application number: M016 Domeboro ALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATE Advantice Health, LLC. 28c39200-2f7c-954b-3ce7-7349b2738812 2024-12-12 Warnings Exact identifier application number: M016 Atopis Eczema Therapy Cream COLLOIDAL OATMEAL Bionona Limited 8d4b4a14-b631-f2fa-e053-2a95a90a932f 2024-12-12 Warnings Exact identifier application number: M016 Desitin Daily Defense Zinc Oxide Diaper Rash ZINC OXIDE Kenvue Brands LLC b6e0d1a3-e469-4102-916b-d5cc8ca12e73 2024-12-11 Warnings Exact identifier application number: M016 Little Me Multipurpose Baby Balm WHITE PETROLATUM Shalom International Corp e09518f1-3691-4d85-a8e1-a5c452057066 2024-12-11 Warnings Exact identifier application number: M016
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Marketing end Sample Exclude flag Status 78495-004-01 78495000401 113 g in 1 JAR (78495-004-01) 113 g 2020-12-01 0000-00-00 No No Current