FDA.reportPublic FDA data

DUKAL WHITE PETROLATUM

Product NDC
65517-2023
11-digit product format
655172023
Labeler code
65517
Product ID
65517-2023_26bc7f03-950e-5fc7-e063-6394a90a3e4d
Type
HUMAN OTC DRUG
Nonproprietary name
PETROLATUM
Dosage form
JELLY
Route
TOPICAL
Labeler
Dukal LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2023-12-13
Substance
PETROLATUM
Active strength
1 g/g
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
DUKAL WHITE PETROLATUM
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
4T6H12BN9UInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
0c6474ed-2343-d5f2-e063-6394a90a30b3Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
65517-2023-1DUKAL WHITE PETROLATUM6 in 1 CASEJELLY65
65517-2023-1DUKAL WHITE PETROLATUM144 in 1 BOXJELLY1445
65517-2023-2DUKAL WHITE PETROLATUM144 in 1 CASEJELLY1445
65517-2023-2DUKAL WHITE PETROLATUM28 g in 1 TUBEJELLY285

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
65517-2023DUKAL WHITE PETROLATUM (PETROLATUM) JELLY [DUKAL LLC]5Current NDC, 4 package rows20241208_0c6474ed-2343-d5f2-e063-6394a90a30b3.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 53 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CVS Eczema Relief Skin ProtectantOATMEALCVS Health3cf25c43-592f-41cb-aa0b-a82f4e7faf3d2024-11-11WarningsExact identifier
application number: M016
DGH Advanced Formula Scar Skin ProtectantALLANTOINDolgencorp Inc950dcffd-d2c3-4ca7-8a15-7cb1016ca3642024-11-08WarningsExact identifier
application number: M016
ABC Arbonne Baby Care Diaper RashDIMETHICONE AND ZINC OXIDEArbonne International, LLCdd1d8198-bb9d-4508-a971-ae3bc624cdd12024-11-08WarningsExact identifier
application number: M016
SUPER SENSITIVE DIAPER RASHZINC OXIDEORGANIC & SUSTAINABLE BEAUTYb0de2a9b-7854-4caf-b7ff-632c1d4a382e2024-11-08WarningsExact identifier
application number: M016
DoveDERMASERIES ECZEMA RELIEF SOOTHING BODY LOTIONConopco, Inc. d/b/a/ Unileverbcfb12ea-304e-7d8c-e053-2a95a90af6062024-11-07WarningsExact identifier
application number: M016
VaselineCLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAMConopco, Inc. d/b/a/ Unileverbd206830-e334-3764-e053-2995a90a74ca2024-11-07WarningsExact identifier
application number: M016
DoveMEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BARConopco Inc. d/b/a/ Unileverb9e61a03-e000-50ab-e053-2a95a90a32102024-11-07WarningsExact identifier
application number: M016
DoveDOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASHConopco Inc. d/b/a/ Unileverb9f8cb31-560c-79e0-e053-2a95a90a39ae2024-11-07WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL HAND WASHConopco Inc. d/b/a/ Unilevered234413-777a-9c82-e053-2a95a90a6f982024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceCATCHING THE SUNRISE HAND SANITIZERConopco Inc. d/b/a/ Unileverb9fa6c72-7c56-6fd0-e053-2995a90a67072024-11-07WarningsExact identifier
application number: M016
DoveCARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASHConopco Inc. d/b/a/ Unilevered24b320-27fc-9714-e053-2995a90a79a62024-11-07WarningsExact identifier
application number: M016
SKINSEIETHYL ALCOHOL LIQUIDConopco Inc. d/b/a/ Unilevera603c419-238f-0bae-e053-2a95a90abc2b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceUNDER THE STARLIT SKY HAND SANITIZERConopco Inc. d/b/a/ Unileverba0dfe52-c550-94fd-e053-2995a90a98002024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUMMERTIME SPRINKLERS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0e474c-db62-910f-e053-2995a90a889e2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceGIRLS NIGHT OUT HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ce03e-5e7b-b09a-e053-2995a90a4eef2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceAFTER THE RAIN HAND SANITIZERConopco Inc. d/b/a/ Unileverba0d27fb-f72f-5e87-e053-2a95a90af7e02024-11-07WarningsExact identifier
application number: M016
Love Beauty and PlanetBELOVED CATCUS FLOWER AND BASIL HAND SANITIZERConopco Inc. d/b/a/ Unileverba47599c-3e11-cec3-e053-2a95a90aef7b2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceWRAPPED IN YOUR ARMS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0ef938-da18-3b9c-e053-2995a90acb722024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceSUNKISSED OCEAN WAVES HAND SANITIZERConopco Inc. d/b/a/ Unileverba0db6a3-222a-093f-e053-2a95a90ac88a2024-11-07WarningsExact identifier
application number: M016
Find Your Happy PlaceLAZY WEEKENDS HAND SANITIZERConopco Inc. d/b/a/ Unileverba0f4571-e752-d925-e053-2995a90afd3a2024-11-07WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN0c6474ed-2343-d5f2-e063-6394a90a30b35
204754petrolatum 1 MG/MG Topical OintmentSCD0c6474ed-2343-d5f2-e063-6394a90a30b35
204754petrolatum 100 % Topical JellySY0c6474ed-2343-d5f2-e063-6394a90a30b35

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
65517-2023-1655172023016 BOX in 1 CASE (65517-2023-1) / 144 PACKET in 1 BOX / 5 g in 1 PACKET6 box2023-12-13NoNoCurrent
65517-2023-265517202302144 TUBE in 1 CASE (65517-2023-2) / 28 g in 1 TUBE144 tube2024-12-05NoNoCurrent