FDA.reportPublic FDA data

UNIVERSAL BABY FRESH SCENT PETROLEUM

Product NDC
52000-101
11-digit product format
520000101
Labeler code
52000
Product ID
52000-101_e7711f73-4588-4f11-adca-837a66453de6
Type
HUMAN OTC DRUG
Nonproprietary name
White Petroleum
Dosage form
JELLY
Route
TOPICAL
Labeler
Universal Distribution Center LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-11-01
Substance
PETROLATUM
Active strength
99.9 g/100g
NDC exclude flag
No
Listing certified through
2026-12-31
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
UNIVERSAL BABY FRESH SCENT PETROLEUM
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99.9 g/100g

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
1148414Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b6e0ddb8-3761-482a-83d0-15d612d142ebAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52000-101-01UNIVERSAL BABY FRESH SCENT PETROLEUM170 g in 1 JARJELLY1703
52000-101-02UNIVERSAL BABY FRESH SCENT PETROLEUM226 g in 1 JARJELLY2263
52000-101-03UNIVERSAL BABY FRESH SCENT PETROLEUM368 g in 1 JARJELLY3683
52000-101-04UNIVERSAL BABY FRESH SCENT PETROLEUM510 g in 1 JARJELLY5103

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52000-101UNIVERSAL BABY FRESH SCENT PETROLEUM (WHITE PETROLEUM) JELLY [UNIVERSAL DISTRIBUTION CENTER LLC]3Current NDC, Legacy NDC, 4 package rows20231121_b6e0ddb8-3761-482a-83d0-15d612d142eb.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 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Cetaphil HealingPETROLATUMGalderma Laboratories, L.P.e996db17-bd4d-4b06-bb9a-983dbdec80222024-03-13WarningsExact identifier
application number: M016
Diaper Rash Cream 2ozZINC OXIDERejoice International Corp.130a06a7-3360-afed-e063-6294a90ac19f2024-03-06WarningsExact identifier
application number: M016
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
application number: M016
Dermachange ScarALLANTOINPrivate Label Beauty and Wellness12eed473-10d6-49c8-e063-6394a90afb632024-03-05WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
application number: M016
XtraCare Foaming Facial CleanserTRICLOSANRejoice International313fcd4a-8641-417e-bf0b-02359ad815fe2024-02-28WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International5ae6d5d4-caff-4360-a0e7-7c8d7a9b59072024-02-28WarningsExact identifier
application number: M016
XtraCare with cooling action Oatmeal Skin Relief CalminDIMETHICONERejoice International29abd476-c32d-49f0-b283-30f4ba570ab42024-02-28WarningsExact identifier
application number: M016
MAX BARRIER Skin ProtectantZINC OXIDEGL HEALTH, INC.5eec834d-d8f3-49e3-b230-f8cf88b795e62024-02-26WarningsExact identifier
application number: M016
Rugby Petrolatum Hydrating Skin ProtectantPETROLATUMRugby Laboratoriesad63e345-1fe8-4f9a-a32e-8dfcde31bedc2024-02-12WarningsExact identifier
application number: M016
A and DPETROLATUMSafetec of America, Inc.b9afda3a-9e1d-46c1-b7aa-c3143caf709e2024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Mint BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc86fc9f3c-e35f-4988-bf19-64d9c6c85ee92024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Berry BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc827365b3-b3a5-4472-9add-f822362c47312024-02-09WarningsExact identifier
application number: M016
Blistex Medicated Lip BalmDIMETHICONE, OCTINOXATE, AND OCTISALATEBlistex Inc8b4160ed-8889-4e3a-947f-a56c3324dbbe2024-02-09WarningsExact identifier
application number: M016
MedlineWHITE PETROLATUM, ZINC OXIDEMedline Industries, LP101b9933-c2b8-0fdd-e063-6294a90a306a2024-01-29WarningsExact identifier
application number: M016
XtraCare Skin Relief Oatmeal Daily MoisturizingDIMETHICONERejoice International8d9e0893-c9be-4f5a-afc2-b5b997c8d1cc2024-01-29WarningsExact identifier
application number: M016
Cetaphil Baby HealingPETROLATUMGalderma Laboratories, L.P.5140754e-5db0-470f-adfd-de02b184880b2024-01-29WarningsExact identifier
application number: M016
CHAPSTICK CLASSIC MEDICATEDCAMPHOR, MENTHOL, PETROLATUMHaleon US Holdings LLCb4259621-ff41-46cc-a658-b57bff3c15252024-01-23WarningsExact identifier
application number: M016
Zinc Oxide 20%ZINC OXIDETrifecta Pharmaceuticals USAfcef17f1-84e7-a288-e053-6294a90a064b2024-01-19WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSNb6e0ddb8-3761-482a-83d0-15d612d142eb3
1148414petrolatum 0.999 MG/MG Topical GelSCDb6e0ddb8-3761-482a-83d0-15d612d142eb3
1148414petrolatum 99.9 % Topical JellySYb6e0ddb8-3761-482a-83d0-15d612d142eb3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52000-101-0152000010101170 g in 1 JAR (52000-101-01) 170 g2019-11-010000-00-00NoNoCurrent
52000-101-0252000010102226 g in 1 JAR (52000-101-02) 226 g2019-11-010000-00-00NoNoCurrent
52000-101-0352000010103368 g in 1 JAR (52000-101-03) 368 g2019-11-010000-00-00NoNoCurrent
52000-101-0452000010104510 g in 1 JAR (52000-101-04) 510 g2019-11-010000-00-00NoNoCurrent