FDA.reportPublic FDA data

Petroleum with Cocoa

Product NDC
83324-258
11-digit product format
833240258
Labeler code
83324
Product ID
83324-258_437d4081-1d3b-b2c7-e063-6394a90a2cf0
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
QUALITY CHOICE (Chain Drug Marketing Association)
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-11-01
Substance
PETROLATUM
Active strength
99.89 g/100g
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
Petroleum with Cocoa
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99.89 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
086b6563-cb73-4874-aa42-028f5e81b60dAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
83324-258-75Petroleum with Cocoa212 g in 1 JARJELLY2121

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 46 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLC1ac59efd-9efd-09d9-e063-6394a90a5e402025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa3424b96-74b0-21c4-e053-2a95a90ae7ea2025-01-20WarningsExact identifier
application number: M016
Hand Sanitizer WipesALCOHOLHANUL CO.,LTDa4eb1cad-a9c0-43d3-e053-2995a90a06a02025-01-20WarningsExact identifier
application number: M016
RICO Hand Sanitizer WipesALCOHOLHANUL CO.,LTDdc8ba3a2-9748-ec52-e053-2995a90a638b2025-01-20WarningsExact identifier
application number: M016
Hand SanitizerALCOHOLHANUL CO.,LTDa4fa65f9-9786-76dd-e053-2995a90a6e132025-01-20WarningsExact identifier
application number: M016
SAN Skinlab Cloth Wet WipesBENZALKONIUM CHLORIDE 0.13%HANUL CO.,LTDc058d278-3d6d-7e3c-e053-2995a90a6c2f2025-01-20WarningsExact identifier
application number: M016
Rico Hand SanitizerALCOHOLHANUL CO.,LTDa6065fcd-3968-d5a1-e053-2a95a90ab8d62025-01-20WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4465b-6e46-51e2-e063-6294a90a695f2025-01-16WarningsExact identifier
application number: M016
VITAMIN A and DWHITE PETROLATUMVIVE HEALTH LLC2bd4a2b0-f586-3ab1-e063-6294a90aa1ed2025-01-16WarningsExact identifier
application number: M016
Dermoia Manuka Honey EczemaOATMEALTREASUREWISE LLC18c174de-6626-45ee-a6aa-f75a48daab8d2025-01-15WarningsExact identifier
application number: M016
AllantoinMEDICINAL MASSAGE OILCarolina Cannabis Creations L.L.C04b5619b-2122-f159-e063-6394a90a2e052025-01-15WarningsExact identifier
application number: M016
Skin Barista 2in1 White Body PerfectionDIMETHICONEPioom Cosmetic Co.,ltd2d7fc20c-31a7-195b-e054-00144ff88e882025-01-15WarningsExact identifier
application number: M016
Skin Barista Rice Bran Cleansing FoamALLANTOINPioom Cosmetic Co.,ltd2d7fc7f6-1e89-116c-e054-00144ff8d46c2025-01-15WarningsExact identifier
application number: M016
Hammertech Vitamin A and DWHITE PETROLATUMHAMMER TECH LLCffe96aa1-db6b-33e4-e053-6394a90a7e4e2025-01-14WarningsExact identifier
application number: M016
NOON Cartessa Accelerate ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd400ead81-ab07-400f-b261-db330e0fd0042025-01-14WarningsExact identifier
application number: M016
NOON Post Procedure ProgramALLANTOIN, TITANIUM DIOXIDE, OCTOCRYLENE, AND AVOBENZONENoon Aesthetics M.R. Ltd9d1d11b4-40ff-4ea8-a3af-655f457c05f12025-01-14WarningsExact identifier
application number: M016
OLP diaper Rash cream A and DZINC OXIDEOL PHARMA TECH, LLC Drs PHARMACYd6faa4d9-751c-a1b6-e053-2a95a90aee5b2025-01-09WarningsExact identifier
application number: M016
ANTI-ITCHZINC ACETATE , DIPHENHYDRAMINEOL PHARMA TECH, LLCb79d3096-c609-e710-e053-2995a90a8da22025-01-09WarningsExact identifier
application number: M016
ANTIBACTERIAL DREAMY FLORALSGLYCERINQuimicas Handal de Centroamerica SA de CV09f73bec-516d-90f0-e063-6394a90aecab2025-01-08WarningsExact identifier
application number: M016
AOAO Repair Foot CreamUREA,SALICYLIC ACID,TOCOPHEROL,CAMELLIA SINENSIS LEAF EXTRACT,ALOE VERA LEAF EXTRACT,COCOS NUCIFERA (COCONUT) OIL.Guangdong Junhui Biotechnology Co.,LTD21064e84-c827-ca82-e063-6394a90a6c652025-01-08WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSN086b6563-cb73-4874-aa42-028f5e81b60d1
1148414petrolatum 0.999 MG/MG Topical GelSCD086b6563-cb73-4874-aa42-028f5e81b60d1
1148414petrolatum 99.9 % Topical JellySY086b6563-cb73-4874-aa42-028f5e81b60d1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83324-258-7583324025875212 g in 1 JAR (83324-258-75) 212 g2025-11-01NoNoCurrent