FDA.reportPublic FDA data

Petroleum

Product NDC
53329-068
Requested package NDC
53329-068-01
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

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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
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 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