FDA.reportPublic FDA data

Health Smart Baby Petroleum

Product NDC
52862-015
11-digit product format
528620015
Labeler code
52862
Product ID
52862-015_298ce21f-2595-1a4d-e063-6294a90a2607
Type
HUMAN OTC DRUG
Nonproprietary name
White Petroleum
Dosage form
JELLY
Route
TOPICAL
Labeler
Home Smart Products
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-07-28
Substance
PETROLATUM
Active strength
99.9 g/100g
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 11 matching rows.

View current auxiliary records. · View the auxiliary file history.

Dataset, Scope, Package NDC table
DatasetScopePackage NDC
excluded productproduct
excluded packagepackage52862-015-25
excluded packagepackage52862-015-24
excluded packagepackage52862-015-21
excluded packagepackage52862-015-22
excluded packagepackage52862-015-01
excluded packagepackage52862-015-19
excluded packagepackage52862-015-26
excluded packagepackage52862-015-23
excluded packagepackage52862-015-14
excluded packagepackage52862-015-20

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
Health Smart Baby Petroleum
Listing expiration
2027-12-31

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
edd9d018-c2c9-4a9a-b727-0a92cd463c02Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52862-015-012020-08-11Health Smart Baby Petroleum
52862-015-142020-08-11Health Smart Baby Petroleum
52862-015-192020-08-11Health Smart Baby Petroleum
52862-015-202020-08-11Health Smart Baby Petroleum
52862-015-212020-08-11Health Smart Baby Petroleum
52862-015-222020-08-11Health Smart Baby Petroleum
52862-015-232020-08-11Health Smart Baby Petroleum
52862-015-242020-08-11Health Smart Baby Petroleum
52862-015-252020-08-11Health Smart Baby Petroleum
52862-015-262020-08-11Health Smart Baby Petroleum
52862-015-012020-01-31Health Smart Baby Petroleum
52862-015-142020-01-31Health Smart Baby Petroleum
52862-015-192020-01-31Health Smart Baby Petroleum
52862-015-202020-01-31Health Smart Baby Petroleum
52862-015-212020-01-31Health Smart Baby Petroleum
52862-015-222020-01-31Health Smart Baby Petroleum
52862-015-232020-01-31Health Smart Baby Petroleum
52862-015-242020-01-31Health Smart Baby Petroleum
52862-015-252020-01-31Health Smart Baby Petroleum
52862-015-262020-01-31Health Smart Baby Petroleum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-015-01Health Smart Baby Petroleum226 g in 1 BOTTLEJELLY2263
52862-015-14Health Smart Baby Petroleum113 g in 1 BOTTLEJELLY1133
52862-015-19Health Smart Baby Petroleum50 g in 1 BOTTLEJELLY503
52862-015-20Health Smart Baby Petroleum100 g in 1 BOTTLEJELLY1003
52862-015-21Health Smart Baby Petroleum170 g in 1 BOTTLEJELLY1703
52862-015-22Health Smart Baby Petroleum283 g in 1 BOTTLEJELLY2833
52862-015-23Health Smart Baby Petroleum368 g in 1 BOTTLEJELLY3683
52862-015-24Health Smart Baby Petroleum425 g in 1 BOTTLEJELLY4253
52862-015-25Health Smart Baby Petroleum450 g in 1 BOTTLEJELLY4503
52862-015-26Health Smart Baby Petroleum500 g in 1 BOTTLEJELLY5003

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UHEALTH SMART BABY PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]1
PETROLATUMACTIVE MOIETY4T6H12BN9UHEALTH SMART BABY PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-015HEALTH SMART BABY PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]3Current NDC, Legacy NDC, 10 package rows20241222_edd9d018-c2c9-4a9a-b727-0a92cd463c02.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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Petrolatum JellyPETROLATUMNEW PRIDE CORPf6634410-fa1f-7987-e053-2995a90abb062023-12-01WarningsExact identifier
application number: M016
Cetaphil Cracked Skin Repair BalmDIMETHICONEGalderma Laboratories, L.P.5efb3ef0-6ee9-4ef8-b81e-90bd1825c9562023-11-30WarningsExact identifier
application number: M016
Cetaphil Cracked Skin RepairDIMETHICONEGalderma Laboratories, L.P.27d74e0f-8359-4c59-bf7f-acade7f4545c2023-11-30WarningsExact identifier
application number: M016
Sheffield Advanced Scar GelADVANCED SCAR GELSheffield Pharmaceuticals LLCab78b946-81ed-442c-a167-26c26c7fe8a12023-11-30WarningsExact identifier
application number: M016
Akin Diaper RashZINC OXIDESouthern Sales & Service, Inc.f5515517-7977-48f9-aab6-cf0d2f2a04a02023-11-29WarningsExact identifier
application number: M016
Dr. Sheffield Diaper RashZINC OXIDESheffield Pharmaceuticals LLCcac77320-b5cf-4edf-9693-ebabfb61390c2023-11-28WarningsExact identifier
application number: M016
Sheffield Zinc OxideZINC OXIDESheffield Pharmaceuticals LLC60b54c04-4387-4954-951d-1658099473102023-11-28WarningsExact identifier
application number: M016
Cetaphil Baby Soothe and Protect CreamALLANTOINGalderma Laboratories, L.P.38254e03-3716-4e45-86b7-06430ebadc862023-11-22WarningsExact identifier
application number: M016
Cetaphil Baby Eczema SoothingCOLLOIDAL OATMEALGalderma Laboratories, L.P.d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b2023-11-22WarningsExact identifier
application number: M016
EczemaHoneyBodyLotionCOLLOIDAL OATMEALAllure Labs0a710be0-562e-8368-e063-6294a90a3b1b2023-11-18WarningsExact identifier
application number: M016
Zinc OxideSKIN PROTECTANTBluePoint Laboratoriesd9b752e6-655a-19a6-e053-2995a90a9a372023-11-17WarningsExact identifier
application number: M016
UNIVERSAL ORIGINAL PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC47b8c720-ad1e-4ac7-ba73-872e409b38bf2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLC1ac9ee69-339d-4426-b3bf-13e5386f1a9b2023-11-17WarningsExact identifier
application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCcf888bf3-6950-43aa-b4be-5a32961b4d962023-11-15WarningsExact identifier
application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUMWHITE PETROLEUMUniversal Distribution Center LLCb6e0ddb8-3761-482a-83d0-15d612d142eb2023-11-15WarningsExact identifier
application number: M016
DERMA SANTE Anti Eczema CreamOATMEALHope Science Inc.1492a6ad-016c-4307-8286-5c564de9e1602023-11-11WarningsExact identifier
application number: M016
M3 NATURALS Eczema CreamOATMEALM3 Naturals LLC45e2cdde-58fb-4eea-a54d-f53f9ad0d8542023-11-11WarningsExact identifier
application number: M016
THERAPLEX Eczema TherapyOATMEALTHERAPLEX, LLC53900588-5c9e-4164-816d-017bdbb0f31b2023-11-11WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash Max StrengthZINC OXIDEGeodis Logistics LLC1b4fd6cb-f2dc-40a2-b958-e99caec917932023-11-10WarningsExact identifier
application number: M016
Boudreauxs Butt Diaper Rash OriginalZINC OXIDEGeodis Logistics LLC97587458-4ca0-4de3-9bb9-148346d859c02023-11-10WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSNedd9d018-c2c9-4a9a-b727-0a92cd463c023
1148414petrolatum 0.999 MG/MG Topical GelSCDedd9d018-c2c9-4a9a-b727-0a92cd463c023
1148414petrolatum 99.9 % Topical JellySYedd9d018-c2c9-4a9a-b727-0a92cd463c023

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-015-0152862001501226 g in 1 BOTTLE (52862-015-01) 226 g2013-07-280000-00-00NoNoCurrent
52862-015-1452862001514113 g in 1 BOTTLE (52862-015-14) 113 g2013-07-280000-00-00NoNoCurrent
52862-015-195286200151950 g in 1 BOTTLE (52862-015-19) 50 g2013-07-280000-00-00NoNoCurrent
52862-015-2052862001520100 g in 1 BOTTLE (52862-015-20) 100 g2013-07-280000-00-00NoNoCurrent
52862-015-2152862001521170 g in 1 BOTTLE (52862-015-21) 170 g2013-07-280000-00-00NoNoCurrent
52862-015-2252862001522283 g in 1 BOTTLE (52862-015-22) 283 g2013-07-280000-00-00NoNoCurrent
52862-015-2352862001523368 g in 1 BOTTLE (52862-015-23) 368 g2013-07-280000-00-00NoNoCurrent
52862-015-2452862001524425 g in 1 BOTTLE (52862-015-24) 425 g2013-07-280000-00-00NoNoCurrent
52862-015-2552862001525450 g in 1 BOTTLE (52862-015-25) 450 g2013-07-280000-00-00NoNoCurrent
52862-015-2652862001526500 g in 1 BOTTLE (52862-015-26) 500 g2013-07-280000-00-00NoNoCurrent