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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalamineFERRIC OXIDE REDPerrigo Direct, Inc256bd1d4-fd50-408f-9aee-84f218bb49712026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMPerrigo Direct, Ince11470b2-80d6-4008-b87e-eb6aeadfce742026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEPerrigo Direct, Inccc0378f2-6d5f-47ec-b16a-64668b4c29cc2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXIND HCLPerrigo Direct, Inc54a20ec9-ab86-4410-af94-e04393e9d4b32026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DLANOLIN, PETROLATUMMeijer, Inc.adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEMeijer, Inc.1b72f927-c2ae-4190-a035-5d7bb9f53c152026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Petroleum Skin ProtectantWHITE PETROLATUMMeijer, Inc.af293cc0-ccd5-42a6-861b-c19fa6ffd06a2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMMeijer, Inc.09878fe0-0890-4af3-a3f6-d2890041e9f82026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEMeijer, Inc.fa8ae34c-7b68-454f-8a3b-0eaa93a340922026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Baby Diaper RashZINC OXIDEMeijer, Inc.04bec667-a11e-42d2-a4b3-1416eebf1e8d2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
HealingPETROLATUMMeijer, Inc.8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLMeijer, Inc.6b369ef2-fd54-4931-a9eb-0fb42834c2ef2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
DimethiconeDIMETHICONEMeijer, Inc.75b91b97-ea84-4c4d-9e58-5a9ff27a778c2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALMeijer, Inc.d36a7479-7b3b-49fe-8144-b5cce0e173fb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Daily MoisturizingDAILY MOISTURIZINGMeijer, Inc.44949b46-70f2-4e52-adba-a8455da614eb2026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELMeijer, Inc.13e4aece-5b91-4f89-a912-540bf170a8d12026-02-19Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDETarget Corporation7fb5f9ca-cd90-4933-9fe8-907ece00458b2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDTarget Corporationd4ee05c8-ae62-45df-8783-1ed57fa030ec2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMTarget Corporation5237c7f2-7135-4558-a758-4fc2a232172f2026-02-18Warnings, Adverse reactionsExact identifier
application number: M016
Advanced HealingPETROLATUMTarget Corporation3e620e4f-9e29-9e39-e063-6394a90adeda2026-02-18Warnings, Adverse reactionsExact 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