FDA.reportPublic FDA data

Health Smart Cocoa Butter Petroleum

Product NDC
52862-014
11-digit product format
528620014
Labeler code
52862
Product ID
52862-014_298ceaec-69ec-06d6-e063-6394a90a3654
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 packagepackage52862-014-14
excluded packagepackage52862-014-25
excluded packagepackage52862-014-20
excluded packagepackage52862-014-19
excluded packagepackage52862-014-24
excluded packagepackage52862-014-23
excluded packagepackage52862-014-01
excluded packagepackage52862-014-22
excluded packagepackage52862-014-26
excluded packagepackage52862-014-21

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 Cocoa Butter 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
a65c8267-d34f-4542-a7ca-5180e860a03dAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52862-014-012020-08-11Health Smart Cocoa Butter Petroleum
52862-014-142020-08-11Health Smart Cocoa Butter Petroleum
52862-014-192020-08-11Health Smart Cocoa Butter Petroleum
52862-014-202020-08-11Health Smart Cocoa Butter Petroleum
52862-014-212020-08-11Health Smart Cocoa Butter Petroleum
52862-014-222020-08-11Health Smart Cocoa Butter Petroleum
52862-014-232020-08-11Health Smart Cocoa Butter Petroleum
52862-014-242020-08-11Health Smart Cocoa Butter Petroleum
52862-014-252020-08-11Health Smart Cocoa Butter Petroleum
52862-014-262020-08-11Health Smart Cocoa Butter Petroleum
52862-014-012020-01-31Health Smart Cocoa Butter Petroleum
52862-014-142020-01-31Health Smart Cocoa Butter Petroleum
52862-014-192020-01-31Health Smart Cocoa Butter Petroleum
52862-014-202020-01-31Health Smart Cocoa Butter Petroleum
52862-014-212020-01-31Health Smart Cocoa Butter Petroleum
52862-014-222020-01-31Health Smart Cocoa Butter Petroleum
52862-014-232020-01-31Health Smart Cocoa Butter Petroleum
52862-014-242020-01-31Health Smart Cocoa Butter Petroleum
52862-014-252020-01-31Health Smart Cocoa Butter Petroleum
52862-014-262020-01-31Health Smart Cocoa Butter Petroleum

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52862-014-01Health Smart Cocoa Butter Petroleum226 g in 1 BOTTLEJELLY2263
52862-014-14Health Smart Cocoa Butter Petroleum113 g in 1 BOTTLEJELLY1133
52862-014-19Health Smart Cocoa Butter Petroleum50 g in 1 BOTTLEJELLY503
52862-014-20Health Smart Cocoa Butter Petroleum100 g in 1 BOTTLEJELLY1003
52862-014-21Health Smart Cocoa Butter Petroleum170 g in 1 BOTTLEJELLY1703
52862-014-22Health Smart Cocoa Butter Petroleum283 g in 1 BOTTLEJELLY2833
52862-014-23Health Smart Cocoa Butter Petroleum368 g in 1 BOTTLEJELLY3683
52862-014-24Health Smart Cocoa Butter Petroleum425 g in 1 BOTTLEJELLY4253
52862-014-25Health Smart Cocoa Butter Petroleum450 g in 1 BOTTLEJELLY4503
52862-014-26Health Smart Cocoa Butter Petroleum500 g in 1 BOTTLEJELLY5003

DailyMed Socrata Ingredients#

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

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52862-014HEALTH SMART COCOA BUTTER PETROLEUM (WHITE PETROLEUM) JELLY [HOME SMART PRODUCTS]3Current NDC, Legacy NDC, 10 package rows20241220_a65c8267-d34f-4542-a7ca-5180e860a03d.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 60 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
THERA Calazinc Body ShieldZINC OXIDEMcKesson Medical-Surgical Inc.974b1046-83ee-4207-91d3-40982beb9c632024-06-17WarningsExact identifier
application number: M016
DimethiconeBODY CLEANSERMcKesson8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a82024-06-14WarningsExact identifier
application number: M016
Dr. Mom Butt BalmDIMETHICONE PETROLATUMFerndale Laboratories, Inc.ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd2024-06-13WarningsExact identifier
application number: M016
Secura ProtectivePETROLATUMSmith & Nephew Medical Ltd20906566-fbf2-46d9-a5d8-c7f7356d10802024-06-12WarningsExact identifier
application number: M016
CalamineFERRIC OXIDE REDNuCare Pharmaceuticals,Inc.66e98554-e158-a519-e053-2a91aa0a67832024-06-06Warnings, Adverse reactionsExact identifier
application number: M016
CVS Health Vitamin A and D Skin ProtectantLANOLIN AND PETROLATUMCVS Healthfe3ccabb-9644-4091-9dca-ffd96a43ecaf2024-05-28WarningsExact identifier
application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper RashZINC OXIDEBabo Botanicals, Inc.186a9642-cd73-adfb-e063-6394a90a75c72024-05-14WarningsExact identifier
application number: M016
Honest Eczema BalmCOLLOIDAL OATMEALThe Honest Company, Inc.35b8bc5c-420e-4d31-9659-f36cabbd897a2024-05-14WarningsExact identifier
application number: M016
Extra Strength Itch StoppingITCH STOPPING CREAMUniversal Distribution Centre LLCb9a42aa3-1903-76f0-e053-2a95a90a51d12024-05-13WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONCardinal Health, 110 dba Leader7f733c0a-82b2-d3b0-e053-2991aa0a6b0f2024-05-13WarningsExact identifier
application number: M016
Walgreens Maximum Diaper RashZINC OXIDEWalgreens Company5eb2152f-6fa2-4191-878a-207416e698182024-05-07WarningsExact identifier
application number: M016
Cetaphil Eczema Rapid Relief CreamCOLLOIDAL OATMEALGalderma Laboratories, L.P.02a405fa-8ae9-41e9-b86f-ef5fb6e3844a2024-05-02WarningsExact identifier
application number: M016
ChapstickAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC0e34fc74-772e-48fd-a353-58807ef412c12024-05-01WarningsExact identifier
application number: M016
Diaper Rash Cream 40% ZINCZINC OXIDEASTONEA LABS PRIVATE LIMITED16da985a-6210-ec82-e063-6294a90a132d2024-04-24WarningsExact identifier
application number: M016
Petrolatum JellyPETROLATUMASTONEA LABS PRIVATE LIMITED16dac8e5-aeb8-592d-e063-6394a90ae2b62024-04-24WarningsExact identifier
application number: M016
Monistat Complete Care Chafing ReliefDIMETHICONEInsight Pharmaceuticals LLC07d7c883-1fa3-4786-905c-a1fab649765e2024-04-19WarningsExact identifier
application number: M016
zinc oxide 20%ZINC OXIDE 20%Bionpharma Inc1549500a-0941-0fba-e063-6394a90a564e2024-04-18WarningsExact identifier
application number: M016
ARC Skin ProtectantALLANTOINAnjon Biologics, Incf4ff79dd-cb38-4cca-9631-a2758a1718732024-04-18WarningsExact identifier
application number: M016
ZinctralZINC OXIDEPureTek Corporationde990834-00da-0c7a-e053-2995a90a7c372024-04-15WarningsExact identifier
application number: M016
Chapstick Moisturizer Variety PackAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCbfb9a2d5-1ad2-45b8-a215-9d1370af53372024-04-12WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSNa65c8267-d34f-4542-a7ca-5180e860a03d3
1148414petrolatum 0.999 MG/MG Topical GelSCDa65c8267-d34f-4542-a7ca-5180e860a03d3
1148414petrolatum 99.9 % Topical JellySYa65c8267-d34f-4542-a7ca-5180e860a03d3

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52862-014-0152862001401226 g in 1 BOTTLE (52862-014-01) 226 g2013-07-280000-00-00NoNoCurrent
52862-014-1452862001414113 g in 1 BOTTLE (52862-014-14) 113 g2013-07-280000-00-00NoNoCurrent
52862-014-195286200141950 g in 1 BOTTLE (52862-014-19) 50 g2013-07-280000-00-00NoNoCurrent
52862-014-2052862001420100 g in 1 BOTTLE (52862-014-20) 100 g2013-07-280000-00-00NoNoCurrent
52862-014-2152862001421170 g in 1 BOTTLE (52862-014-21) 170 g2013-07-280000-00-00NoNoCurrent
52862-014-2252862001422283 g in 1 BOTTLE (52862-014-22) 283 g2013-07-280000-00-00NoNoCurrent
52862-014-2352862001423368 g in 1 BOTTLE (52862-014-23) 368 g2013-07-280000-00-00NoNoCurrent
52862-014-2452862001424425 g in 1 BOTTLE (52862-014-24) 425 g2013-07-280000-00-00NoNoCurrent
52862-014-2552862001425450 g in 1 BOTTLE (52862-014-25) 450 g2013-07-280000-00-00NoNoCurrent
52862-014-2652862001426500 g in 1 BOTTLE (52862-014-26) 500 g2013-07-280000-00-00NoNoCurrent