FDA.reportPublic FDA data

Novita Petrolatum with Cocoa Butter

Product NDC
52410-1011
11-digit product format
524101011
Labeler code
52410
Product ID
52410-1011_3ca994c0-d9e8-44aa-e063-6294a90a096a
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
2016-10-12
Substance
PETROLATUM
Active strength
99.9 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 Petrolatum with Cocoa Butter
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM99.9 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
1148414Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
3e9c68e5-8983-1a18-e054-00144ff8d46cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
52410-1011-32021-02-243e9c68e5-8983-1a18-e054-00144ff8d46c
52410-1011-52021-02-243e9c68e5-8983-1a18-e054-00144ff8d46c
52410-1011-32021-01-293e9c68e5-8983-1a18-e054-00144ff8d46c
52410-1011-52021-01-293e9c68e5-8983-1a18-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52410-1011-3Novita Petrolatum with Cocoa Butter226 g in 1 JARJELLY2269
52410-1011-5Novita Petrolatum with Cocoa Butter368 g in 1 JARJELLY3689

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
52410-1011NOVITA PETROLATUM WITH COCOA BUTTER (PETROLATUM) JELLY [SHIELD LINE LLC]8Current NDC, Legacy NDC, 2 package rows20240716_3e9c68e5-8983-1a18-e054-00144ff8d46c.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 34 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ODLUMIVIE Salmon DNA Repairing SerumRH-OLIGOPEPTIDE-1ODLUMIVIE435ecb5b-0d12-4da1-e063-6394a90a8be22025-11-11WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMKROGER3feb1346-76b6-fbb6-e063-6394a90a17d12025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Ceramide ReviCell CreamCERAMIDE NPODLUMIVIE435ee48f-1b9e-6d08-e063-6394a90af5b52025-11-11WarningsExact identifier
application number: M016
ODLUMIVIE Dendrobium Restorative MaskDENDROBIUM OFFICINALE STEMODLUMIVIE435ef0e0-50be-c4e4-e063-6294a90a8e8e2025-11-11WarningsExact identifier
application number: M016
Au Kah Chuen FugicalCALAMINE AND DIPHENHYDRAMINE HYDROCHLORIDZhejiang Dingtai Pharmaceutical Co., Ltd5b4add17-6c3d-4093-826a-2edb41c1d1db2025-11-10WarningsExact identifier
application number: M016
TATWAX VITAMINS ADPETROLATUMNantong Health & Beyond Hygienic Products Inc.333fdce4-5a1d-45a4-94fe-81d47ecd26702025-11-07WarningsExact identifier
application number: M016
Arme Scar GelDIMETHICONENanjing Ludejin Corporation Management Co., Ltd42e9a59a-480e-f74a-e063-6294a90a06402025-11-06WarningsExact identifier
application number: M016
Baby Diaper Rash CreamZINC OXIDEHello Bello42f14aa6-5694-7727-e063-6294a90a09f32025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Classic EssenceNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1e874ac0-a993-be9e-e063-6394a90af4242025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Eye CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eeb9c36-5bd8-ec90-e063-6294a90ae4e12025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair SerumNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eb08f86-eb2a-7f29-e063-6294a90a05162025-11-06WarningsExact identifier
application number: M016
Atti amour Rose Anti-Aging Repair Moisturizing CreamNIACINAMIDE, GLYCERINRIVER SUNZ co.,Ltd1eec4cfe-d5a3-3570-e063-6294a90ac38b2025-11-06WarningsExact identifier
application number: M016
Spa Dry Heel Foot ReliefDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.ab8a70f5-1b3e-48a4-a9f7-ebcb30d527a92025-11-05WarningsExact identifier
application number: M016
Royal Jelly Berry Powerful Lip CareDIMETHICONEDistribuidora Comercial Jafra, S.A. de C.V.09323fbe-76b5-48c6-80a7-c35b64110a7d2025-11-05WarningsExact identifier
application number: M016
Pink Eczema CreamCOLLOIDAL OATMEALMOOGOO SKIN CARE PTY LTD3b8d92d0-ab7f-8dd5-e063-6394a90aa3af2025-11-04WarningsExact identifier
application number: M016
MedlineZINC OXIDE, PETROLATUMMedline Industries, LPf162b1a8-65b3-13a8-e053-2a95a90a3f132025-11-04WarningsExact identifier
application number: M016
MedlinePETROLATUMMedline Industries, LPf3062b61-e4c4-9f57-e053-2995a90aa0282025-11-04WarningsExact identifier
application number: M016
Sandra Plasencia Dendrobium Officinale Soothing Biofermented MaskTITANIUM DIOXIDEGuangzhou Meijiao Medical Biotechnology Co., Ltd.3cdf06f2-63f2-7a59-e063-6294a90a72ea2025-11-03WarningsExact identifier
application number: M016
Witch HazelWITCH HAZELPremier Brands of America Inc.38583c02-497b-922c-e063-6294a90a49de2025-11-03WarningsExact identifier
application number: M016
The Zoeun Omega SerumCOLLOIDAL OATMEALSturgeonbio Co.,Ltd.4277da80-b55b-74af-e063-6394a90af3252025-10-31WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1148414petrolatum 99.9 % Topical GelPSN3e9c68e5-8983-1a18-e054-00144ff8d46c9
1148414petrolatum 0.999 MG/MG Topical GelSCD3e9c68e5-8983-1a18-e054-00144ff8d46c9
1148414petrolatum 99.9 % Topical JellySY3e9c68e5-8983-1a18-e054-00144ff8d46c9

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
52410-1011-352410101103226 g in 1 JAR (52410-1011-3) 226 g2016-10-120000-00-00NoNoCurrent
52410-1011-552410101105368 g in 1 JAR (52410-1011-5) 368 g2016-10-120000-00-00NoNoCurrent