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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact 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