FDA.reportPublic FDA data

Pure Petrolatum Jelly

Product NDC
30400-509
11-digit product format
304000509
Labeler code
30400
Product ID
30400-509_5db907a6-e9c2-dcc6-e063-6294a90a7bc9
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Jell Pharmaceuticals Pvt. Ltd.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-15
Substance
PETROLATUM
Active strength
100 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
Pure Petrolatum Jelly
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM100 g/100g

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
30400-509-01Pure Petrolatum Jelly368 g in 1 JARJELLY3682
30400-509-02Pure Petrolatum Jelly226 g in 1 JARJELLY2262

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
30400-509PURE PETROLATUM JELLY (PETROLATUM) JELLY [JELL PHARMACEUTICALS PVT. LTD.]2Current NDC, Legacy NDC, 2 package rows20241220_cdc297cb-476a-6da9-e053-2a95a90a399a.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 61 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ChapStick Supreme Classic CherryWHITE PETROLATUMHaleon US Holdings LLC84d8cc38-83e3-49be-b180-d01820525b602024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLC9cd13fbb-887f-46a8-9f0b-4450ad3e07b72024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Peachy KeenZINC OXIDEHaleon US Holdings LLCef206fe7-2659-41dc-b117-380af704999b2024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Pretty in PinkZINC OXIDEHaleon US Holdings LLCe686ce23-57bc-4026-be62-d46d90ded4422024-03-22WarningsExact identifier
application number: M016
Chapstick Total Hydration Moisture Tint Very BerryZINC OXIDEHaleon US Holdings LLC59023150-65ef-4427-9045-0e64b100cbab2024-03-22WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLC33497c07-ad6e-4c50-bc23-a55725b2eae12024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer OriginalAVOBENZONE, HOMOSALATE, OCTISALATE, OCTOCRYLENE, WHITE PETROLATUMHaleon US Holdings LLCde250ae9-6e4a-46ca-bcc9-5bb07dbb70c52024-03-21WarningsExact identifier
application number: M016
ChapStick Classic StrawberryWHITE PETROLATUMHaleon US Holdings LLC3a279496-74c5-4ab1-ba69-06ad4a4f67cf2024-03-21WarningsExact identifier
application number: M016
Chapstick Moisturizer Cool MintAVOBENZONE, OCTINOXATE, AND WHITE PETROLATUMHaleon US Holdings LLCc1120c7a-1fa8-45a4-8bcf-35d9cc9f2c742024-03-21WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Sore Relief KitALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions523b6598-8039-4116-b0f8-ba31d7d6ea9d2024-03-20WarningsExact identifier
application number: M016
ChapStick Classic CherryWHITE PETROLATUMHaleon US Holdings LLCdb041b1b-084a-4283-b6ba-4d4bcdc220b32024-03-19WarningsExact identifier
application number: M016
ChapStick Classic OriginalWHITE PETROLATUMHaleon US Holdings LLC42fe0f4a-efb7-4e70-a359-db7dc2ac99052024-03-19WarningsExact identifier
application number: M016
ChapStick Classic SpearmintWHITE PETROLATUMHaleon US Holdings LLC74354d8e-c265-4a27-9715-1a4c157ad8902024-03-19WarningsExact identifier
application number: M016
Cetaphil HealingPETROLATUMGalderma Laboratories, L.P.e996db17-bd4d-4b06-bb9a-983dbdec80222024-03-13WarningsExact identifier
application number: M016
Diaper Rash Cream 2ozZINC OXIDERejoice International Corp.130a06a7-3360-afed-e063-6294a90ac19f2024-03-06WarningsExact identifier
application number: M016
mama bear DIAPER RASH Skin ProtectantLANOLIN AND PETROLATUMAMAZON.COM SERVICES LLCcda9ca47-b668-4a65-908d-80b9a6515bd72024-03-06WarningsExact identifier
application number: M016
Dermachange ScarALLANTOINPrivate Label Beauty and Wellness12eed473-10d6-49c8-e063-6394a90afb632024-03-05WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Cocoa Butter EnrichedPETROLEUMRejoice International580d76ee-ea89-426e-bd25-7a58481e97952024-02-28WarningsExact identifier
application number: M016
XtraCare Creamy Petroleum Jelly Vitamin E enrichedPETROLATUMRejoice International2c382a50-93d2-4d28-b7a4-1702b20b71392024-02-28WarningsExact identifier
application number: M016
XtraCare Foaming Facial CleanserTRICLOSANRejoice International313fcd4a-8641-417e-bf0b-02359ad815fe2024-02-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSNcdc297cb-476a-6da9-e053-2a95a90a399a2
204754petrolatum 1 MG/MG Topical OintmentSCDcdc297cb-476a-6da9-e053-2a95a90a399a2
204754petrolatum 100 % Topical JellySYcdc297cb-476a-6da9-e053-2a95a90a399a2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
30400-509-0130400050901368 g in 1 JAR (30400-509-01) 368 g2016-10-150000-00-00NoNoCurrent
30400-509-0230400050902226 g in 1 JAR (30400-509-02) 226 g2016-10-150000-00-00NoNoCurrent
30400-509-0330400050903170 g in 1 CONTAINER (30400-509-03) 170 g2026-08-01NoNoCurrent
30400-509-0430400050904100 g in 1 JAR (30400-509-04) 100 g2016-10-15NoNoCurrent
30400-509-0530400050905155 g in 1 JAR (30400-509-05) 155 g2016-10-15NoNoCurrent
30400-509-0630400050906106 g in 1 JAR (30400-509-06) 106 g2016-10-15NoNoCurrent
30400-509-0730400050907113 g in 1 JAR (30400-509-07) 113 g2016-10-15NoNoCurrent
30400-509-083040005090849 g in 1 JAR (30400-509-08) 49 g2016-10-15NoNoCurrent
30400-509-0930400050909212 g in 1 JAR (30400-509-09) 212 g2016-10-15NoNoCurrent