FDA.reportPublic FDA data

Princess Petroleum

Product NDC
78495-004
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
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Princess Petroleum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM100 g/100g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii4T6H12BN9U
Rxcui204754

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
78495-004-01Princess Petroleum113 g in 1 JARJELLY1132
78495-004-02Princess Petroleum170 g in 1 JARJELLY1702
78495-004-03Princess Petroleum226 g in 1 JARJELLY2262
78495-004-04Princess Petroleum368 g in 1 JARJELLY3682

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
78495-004PRINCESS PETROLEUM (WHITE PETROLATUM) JELLY [ULTRA DISTRIBUTORS INC.]2Current NDC, Legacy NDC, 4 package rows20241220_6d9c92bf-9263-40a4-acac-5c3f0b08c69d.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN6d9c92bf-9263-40a4-acac-5c3f0b08c69d2
204754petrolatum 1 MG/MG Topical OintmentSCD6d9c92bf-9263-40a4-acac-5c3f0b08c69d2
204754petrolatum 100 % Topical JellySY6d9c92bf-9263-40a4-acac-5c3f0b08c69d2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
78495-004-0178495000401113 g in 1 JAR (78495-004-01) 113 g2020-12-010000-00-00NoNoCurrent
78495-004-0278495000402170 g in 1 JAR (78495-004-02) 170 g2020-12-010000-00-00NoNoCurrent
78495-004-0378495000403226 g in 1 JAR (78495-004-03) 226 g2020-12-010000-00-00NoNoCurrent
78495-004-0478495000404368 g in 1 JAR (78495-004-04) 368 g2020-12-010000-00-00NoNoCurrent