Petroleum

Product NDC
53329-068
11-digit product format
533290068
Labeler code
53329
Product ID
53329-068_40c14f0d-cd27-922b-e063-6394a90a375e
Type
HUMAN OTC DRUG
Nonproprietary name
White Petrolatum
Dosage form
JELLY
Route
TOPICAL
Labeler
Medline Industries, LP
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-01-01
Substance
PETROLATUM
Active strength
1 g/g
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage53329-06853329-068-04DDiscontinued by firm2026-10-12
excluded packagepackage53329-06853329-068-44DDiscontinued by firm2026-10-12

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 24 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0553329-068-44d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0553329-068-04d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2653329-068-44f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2653329-068-04f5e01cc5f278…a2eaf40c39c3…
2025-04-01 02:39 UTC · source 2025-03-3153329-068-442ef7874e63bc…57b86245f4fa…
2025-04-01 02:39 UTC · source 2025-03-3153329-068-042ef7874e63bc…57b86245f4fa…
2025-03-28 20:22 UTC · source 2025-03-2853329-068-44a1b67e2a42f9…c4cf2c586c0d…
2025-03-28 20:22 UTC · source 2025-03-2853329-068-04a1b67e2a42f9…c4cf2c586c0d…
2025-03-22 03:12 UTC · source 2025-03-2153329-068-44cfe11265f3b6…090c488252e2…
2025-03-22 03:12 UTC · source 2025-03-2153329-068-04cfe11265f3b6…090c488252e2…
2025-03-10 12:48 UTC · source 2025-03-1053329-068-44cdf11ea48f46…ba0047e9e063…
2025-03-10 12:48 UTC · source 2025-03-1053329-068-04cdf11ea48f46…ba0047e9e063…
2025-02-02 03:52 UTC · source 2025-01-3153329-068-44302b2466d912…e7b80fea0513…
2025-02-02 03:52 UTC · source 2025-01-3153329-068-04302b2466d912…e7b80fea0513…
2025-01-20 13:05 UTC · source 2025-01-2053329-068-44ed331223b511…672a5bd82f5f…
2025-01-20 13:05 UTC · source 2025-01-2053329-068-04ed331223b511…672a5bd82f5f…
2025-01-11 03:41 UTC · source 2025-01-1053329-068-040efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-1053329-068-440efc9e666f02…f202fb6c5f17…
2024-11-09 02:27 UTC · source 2024-11-0853329-068-44ad56d346431e…cc804d4bbf1e…
2024-11-09 02:27 UTC · source 2024-11-0853329-068-04ad56d346431e…cc804d4bbf1e…
2024-10-04 04:10 UTC · source 2024-10-0353329-068-44367a005e9d99…383a685ebd0f…
2024-10-04 04:10 UTC · source 2024-10-0353329-068-04367a005e9d99…383a685ebd0f…
2024-07-10 04:00 UTC · source 2024-07-0953329-068-44557ba5c1ecfa…9c80585c8c6e…
2024-07-10 04:00 UTC · source 2024-07-0953329-068-04557ba5c1ecfa…9c80585c8c6e…

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
Petroleum
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PETROLATUM1 g/g

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
34f3581f-39ba-4f28-9237-52f3820ab4c0Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53329-068-01Petroleum28.4 g in 1 TUBEJELLY28.417
53329-068-01Petroleum1 in 1 BOXJELLY117
53329-068-04Petroleum118.29 g in 1 TUBEJELLY118.2917
53329-068-16Petroleum5 g in 1 PACKETJELLY517
53329-068-44Petroleum113 g in 1 TUBEJELLY11317
53329-068-96Petroleum144 in 1 CARTONJELLY14417

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
53329-068-01GM - Gram53329-0682519f4ed-7728-4e58-bf47-9f93cb91d3ba12021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
PETROLATUMACTIVE INGREDIENT4T6H12BN9UPETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.]7
PETROLATUMACTIVE MOIETY4T6H12BN9UPETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.]7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53329-068PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, LP]16Current NDC, Legacy NDC, 6 package rows20250112_34f3581f-39ba-4f28-9237-52f3820ab4c0.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 9 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
SUPRADERMWHITE PETROLATUM, LANOLINOlen Skin Care Corporation4e7199bd-52c6-48e9-9c78-c84e45412faf2026-06-10WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP509ee758-9d53-220c-e063-6394a90a4bd52026-06-09WarningsExact identifier
application number: M016
BABY BUM DIAPERZINC OXIDECreative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare53d8a654-aaec-6f91-e063-6394a90a73512026-06-09WarningsExact identifier
application number: M016
CELISTAR MICRONEEDLING INFUSIONHYALURONATE SODIUMGuangdong Outeli Biotechnology Co., Ltd.53de46a7-3947-70a7-e063-6294a90ab8292026-06-09WarningsExact identifier
application number: M016
MedlineDIMETHICONEMedline Industries, LP3c448cf7-8ca5-c7f7-e063-6294a90a75ff2026-06-08WarningsExact identifier
application number: M016
WOODSLEEP Wild Yam CreamGLYCERINShantou Woodsleep Biotechnology Co., Ltd.53b992fd-5759-57bb-e063-6394a90a16002026-06-08WarningsExact identifier
application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing SerumGLYCERINShantou Ximonth Biotechnology Co., Ltd.53bab969-8407-6334-e063-6294a90aa5d12026-06-08WarningsExact identifier
application number: M016
GNP Calamine Topical SuspensionCALAMINE 8% AND ZINC OXIDE 8%Amerisource Bergen777b0e66-1bce-4483-9dad-c46796fd6f232026-06-04WarningsExact identifier
application number: M016
GNP CaldyphenCALAMINE AND PRAMOXINE HYDROCHLORIDEAmerisource Bergen515c58d7-0dc4-45e7-9155-e5270a16290e2026-06-04WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company535a0e8e-6bb4-6652-e063-6394a90aa7ff2026-06-03WarningsExact identifier
application number: M016
Quad WashDIMETHICONEDynarex Corporation535dc862-6a18-26c9-e063-6294a90a3d4a2026-06-03WarningsExact identifier
application number: M016
First Aid Beauty Sensitive Skin Bestsellers KitCOLLOIDAL OATMEALJCS Global Distribution, Inc.535e42a1-8b14-324d-e063-6394a90a3f652026-06-03WarningsExact identifier
application number: M016
Petroleum Jelly Skin ProtectantWHITE PETROLATUMAcme United Corporation535e94bb-21e8-90be-e063-6394a90a37bb2026-06-03WarningsExact identifier
application number: M016
ADVANCED HEALINGPETROLATUMRejoice International Corp.532c7e5a-4d05-3bd0-e063-6294a90aee002026-06-01WarningsExact identifier
application number: M016
PUTRIZEN 40 UREAGLYCERINShantou Ximonth Biotechnology Co., Ltd.533dadbc-6f20-d880-e063-6394a90a753f2026-06-01WarningsExact identifier
application number: M016
ADVANCED HEALING BALMPETROLATUMRejoice International Corp.53285d82-3755-ca78-e063-6394a90a50192026-05-31WarningsExact identifier
application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown RecoveryCOLLOIDAL OATMEALLOreal USA Products Inc22e088b9-b3b1-4c34-be12-a5a31200ec252026-05-29WarningsExact identifier
application number: M016
Acne Relief CreamNIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOTGuangzhou Senmai Biotechnology Co.,Ltd.53008b89-89ab-7650-e063-6294a90ac16c2026-05-29WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMVASA COSMETICS PRIVATE LIMITED52efd466-49bd-bbdf-e063-6394a90aa1082026-05-28WarningsExact identifier
application number: M016
TheraCare Vitamin A and D plus EPETROLATUMVeridian Healthcare52e0e248-6c04-feb9-e063-6394a90add462026-05-28WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
204754petrolatum 100 % Topical JellyPSN34f3581f-39ba-4f28-9237-52f3820ab4c017
204754petrolatum 1 MG/MG Topical OintmentSCD34f3581f-39ba-4f28-9237-52f3820ab4c017
204754petrolatum 100 % Topical JellySY34f3581f-39ba-4f28-9237-52f3820ab4c017

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
53329-068-01533290068011 TUBE in 1 BOX (53329-068-01) / 28.4 g in 1 TUBE1 tube2018-01-010000-00-00NoNoCurrent
53329-068-0453329006804118.29 g in 1 TUBE (53329-068-04) 118.29 g2019-02-210000-00-00NoNoCurrent
53329-068-16533290068165 g in 1 PACKET (53329-068-16) 5 g2018-01-010000-00-00NoNoCurrent
53329-068-4453329006844113 g in 1 TUBE (53329-068-44) 113 g2018-01-012022-01-01NoNoCurrent
53329-068-9653329006896144 PACKET in 1 CARTON (53329-068-96) / 5 g in 1 PACKET (53329-068-16) 144 packet2018-01-010000-00-00NoNoCurrent