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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED COLLAGENANUBIS COSMETICS SLf564bbf0-3b5c-4a81-e053-2a95a90a7ea62023-08-29WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016
Badger After-BUG BalmCOLLOIDAL OATMEALW.S. Badger Company, Inc.a623da47-cef2-146f-e053-2a95a90afe3a2021-11-17WarningsExact identifier
application number: M016
Derma-e Eczema ReliefOATMEALTopiderm, Ince1797f81-af4b-49e1-9906-dbfd904a282b2020-08-19WarningsExact identifier
application number: M016
Resurfix PlusPETROLATUMTopiderm, Inc.f100f43d-6ace-4c3a-9c85-640c0ab2e3602019-11-19WarningsExact 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