FDA.reportPublic FDA data

Cocoa Butter Petroleum Jelly

Product NDC
30400-503
11-digit product format
304000503
Labeler code
30400
Product ID
30400-503_5db79a5b-ff01-4da8-e063-6294a90ab74a
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Jell Pharmaceuticals Pvt. Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2020-12-24
Substance
PETROLATUM
Active strength
99 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
Cocoa Butter Petroleum Jelly
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-503-01Cocoa Butter Petroleum Jelly49 g in 1 JARJELLY492
30400-503-02Cocoa Butter Petroleum Jelly100 g in 1 JARJELLY1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-503COCOA BUTTER PETROLEUM JELLY (WHITE PETROLATUM) JELLY [JELL PHARMACEUTICALS PVT. LTD.]2Current NDC, Legacy NDC, 2 package rows20241219_cdac43bc-8350-6818-e053-2a95a90aac02.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 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Arthcal Bioidentical Peach CreamARTHCAL BIOIDENTICAL PEACH CREAMBeijing JUNGE Technology Co., Ltd.3c77f787-b7dd-6813-e063-6394a90aa0042025-08-16Boxed warning, WarningsExact identifier
application number: M016
Natureplex Diaper RashZINC OXIDENatureplex LLC41fe8db3-727c-4bbe-a5ea-62efee4b97b02025-08-15WarningsExact identifier
application number: M016
Aloe Vera Petrolatum JellyPETROLATUMShield Line LLCfdf3b90e-a434-49b2-e053-6394a90ab1752025-08-15WarningsExact identifier
application number: M016
AmeriDerm PeriShieldZINC OXIDEShield Line LLC417f1541-d65a-4612-b96b-e6183fbef1f32025-08-15WarningsExact identifier
application number: M016
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
application number: M016
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEShield Line LLC890ba245-ef37-4c62-ae82-980cb78acfb62025-08-15WarningsExact identifier
application number: M016
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
application number: M016
Vitacilina Bebe Diaper RashZINC OXIDETaisho Pharmaceutical California Inc.6701e929-700e-40a4-9117-81e36577bfe12025-08-07WarningsExact identifier
application number: M016
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
application number: M016
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
application number: M016
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
application number: M016
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
application number: M016
Earthmed FS Hand and footALLANTOINEarthmed LLC3ba592e9-2ef1-d20a-e063-6394a90a9bae2025-08-05WarningsExact identifier
application number: M016
Earthmed FS massage oilALLANTOINEarthmed LLC3ba64ad2-61b1-8021-e063-6294a90a73352025-08-05WarningsExact identifier
application number: M016
Petroleum JellyBABY PETROLEUM JELLYNeilMed Pharmaceuticals Inc.3b861e02-671a-c9e5-e063-6394a90a8d0f2025-08-04WarningsExact identifier
application number: M016
Earthmed Sport massage oilALLANTOINEarthmed LLC3b92e87d-ba8d-4bac-e063-6294a90a106e2025-08-04WarningsExact identifier
application number: M016
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2471403petrolatum 99 % Topical OintmentPSNcdac43bc-8350-6818-e053-2a95a90aac022
2471403petrolatum 0.99 MG/MG Topical OintmentSCDcdac43bc-8350-6818-e053-2a95a90aac022
2471403petrolatum 99 % Topical OintmentSYcdac43bc-8350-6818-e053-2a95a90aac022

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30400-503-013040005030149 g in 1 JAR (30400-503-01) 49 g2020-12-240000-00-00NoNoCurrent
30400-503-0230400050302100 g in 1 JAR (30400-503-02) 100 g2020-12-240000-00-00NoNoCurrent
30400-503-0330400050303340 g in 1 JAR (30400-503-03) 340 g2020-12-24NoNoCurrent
30400-503-0430400050304170 g in 1 JAR (30400-503-04) 170 g2020-12-24NoNoCurrent
30400-503-0530400050305212 g in 1 JAR (30400-503-05) 212 g2020-12-24NoNoCurrent
30400-503-0630400050306226 g in 1 JAR (30400-503-06) 226 g2020-12-24NoNoCurrent
30400-503-0730400050307368 g in 1 JAR (30400-503-07) 368 g2020-12-24NoNoCurrent