FDA.reportPublic FDA data

Novita Pure Petrolatum Jelly

Product NDC
52410-1010
11-digit product format
524101010
Labeler code
52410
Product ID
52410-1010_3ca9bcad-c6ca-4539-e063-6394a90ac7da
Type
HUMAN OTC DRUG
Nonproprietary name
Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Shield Line LLC
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
2026-12-31
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
Novita Pure Petrolatum Jelly
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM100 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
204754Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
3c55614f-932d-4898-e054-00144ff88e88Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52410-1010-32021-02-243c55614f-932d-4898-e054-00144ff88e88
52410-1010-52021-02-243c55614f-932d-4898-e054-00144ff88e88
52410-1010-32021-01-293c55614f-932d-4898-e054-00144ff88e88
52410-1010-52021-01-293c55614f-932d-4898-e054-00144ff88e88

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-1010-3Novita Pure Petrolatum Jelly226 g in 1 JARJELLY22611
52410-1010-5Novita Pure Petrolatum Jelly368 g in 1 JARJELLY36811

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-1010NOVITA PURE PETROLATUM JELLY (PETROLATUM) JELLY [SHIELD LINE LLC]10Current NDC, Legacy NDC, 2 package rows20240716_3c55614f-932d-4898-e054-00144ff88e88.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 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Vital LineHYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDESANUBIS COSMETICS SLebe024f7-7c45-ad60-e053-2995a90a45d62023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016
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 JellyPSN3c55614f-932d-4898-e054-00144ff88e8811
204754petrolatum 1 MG/MG Topical OintmentSCD3c55614f-932d-4898-e054-00144ff88e8811
204754petrolatum 100 % Topical JellySY3c55614f-932d-4898-e054-00144ff88e8811

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52410-1010-352410101003226 g in 1 JAR (52410-1010-3) 226 g2016-10-150000-00-00NoNoCurrent
52410-1010-552410101005368 g in 1 JAR (52410-1010-5) 368 g2016-10-150000-00-00NoNoCurrent