FDA.reportPublic FDA data

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 firm2026-10-15
excluded packagepackage53329-06853329-068-44DDiscontinued by firm2026-10-15

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#

NDC, Effective, Related label table
NDCEffectiveRelated label
53329-068-012023-08-25068 Curad Petroleum Jelly
53329-068-012023-08-25068 Curad Petroleum Jelly
53329-068-042023-08-25068 Curad Petroleum Jelly
53329-068-042023-08-25068 Curad Petroleum Jelly
53329-068-162023-08-25068 Curad Petroleum Jelly
53329-068-162023-08-25068 Curad Petroleum Jelly
53329-068-442023-08-25068 Curad Petroleum Jelly
53329-068-442023-08-25068 Curad Petroleum Jelly
53329-068-962023-08-25068 Curad Petroleum Jelly
53329-068-962023-08-25068 Curad Petroleum Jelly
53329-068-012023-07-28068 Curad Petroleum Jelly
53329-068-012023-07-28068 Curad Petroleum Jelly
53329-068-042023-07-28068 Curad Petroleum Jelly
53329-068-042023-07-28068 Curad Petroleum Jelly
53329-068-162023-07-28068 Curad Petroleum Jelly
53329-068-162023-07-28068 Curad Petroleum Jelly
53329-068-442023-07-28068 Curad Petroleum Jelly
53329-068-442023-07-28068 Curad Petroleum Jelly
53329-068-962023-07-28068 Curad Petroleum Jelly
53329-068-962023-07-28068 Curad Petroleum Jelly

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 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 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