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
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-068	53329-068-04	D	Discontinued by firm		2026-10-16
excluded package	package	53329-068	53329-068-44	D	Discontinued by firm		2026-10-16

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 date	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	53329-068-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	53329-068-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	53329-068-44	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	53329-068-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	53329-068-44	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	53329-068-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	53329-068-44	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	53329-068-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	53329-068-44	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	53329-068-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	53329-068-44	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	53329-068-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	53329-068-44	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	53329-068-04	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	53329-068-44	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	53329-068-04	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	53329-068-04	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	53329-068-44	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	53329-068-44	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	53329-068-04	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	53329-068-44	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	53329-068-04	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	53329-068-44	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	53329-068-04	`557ba5c1ecfa…`	`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
Ingredient	Strength
PETROLATUM	1 g/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
204754	Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
34f3581f-39ba-4f28-9237-52f3820ab4c0	Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53329-068-01	2023-08-25	068 Curad Petroleum Jelly
53329-068-01	2023-08-25	068 Curad Petroleum Jelly
53329-068-04	2023-08-25	068 Curad Petroleum Jelly
53329-068-04	2023-08-25	068 Curad Petroleum Jelly
53329-068-16	2023-08-25	068 Curad Petroleum Jelly
53329-068-16	2023-08-25	068 Curad Petroleum Jelly
53329-068-44	2023-08-25	068 Curad Petroleum Jelly
53329-068-44	2023-08-25	068 Curad Petroleum Jelly
53329-068-96	2023-08-25	068 Curad Petroleum Jelly
53329-068-96	2023-08-25	068 Curad Petroleum Jelly
53329-068-01	2023-07-28	068 Curad Petroleum Jelly
53329-068-01	2023-07-28	068 Curad Petroleum Jelly
53329-068-04	2023-07-28	068 Curad Petroleum Jelly
53329-068-04	2023-07-28	068 Curad Petroleum Jelly
53329-068-16	2023-07-28	068 Curad Petroleum Jelly
53329-068-16	2023-07-28	068 Curad Petroleum Jelly
53329-068-44	2023-07-28	068 Curad Petroleum Jelly
53329-068-44	2023-07-28	068 Curad Petroleum Jelly
53329-068-96	2023-07-28	068 Curad Petroleum Jelly
53329-068-96	2023-07-28	068 Curad Petroleum Jelly

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-068-01	Petroleum	28.4 g in 1 TUBE	JELLY	28.4	17
53329-068-01	Petroleum	1 in 1 BOX	JELLY	1	17
53329-068-04	Petroleum	118.29 g in 1 TUBE	JELLY	118.29	17
53329-068-16	Petroleum	5 g in 1 PACKET	JELLY	5	17
53329-068-44	Petroleum	113 g in 1 TUBE	JELLY	113	17
53329-068-96	Petroleum	144 in 1 CARTON	JELLY	144	17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-068-01	GM - Gram	53329-068	2519f4ed-7728-4e58-bf47-9f93cb91d3ba	1	2021-03-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.]	7
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, INC.]	7

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-068	PETROLEUM (WHITE PETROLATUM) JELLY [MEDLINE INDUSTRIES, LP]	16	Current NDC, Legacy NDC, 6 package rows	20250112_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 66 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Petrolatum Jelly	PETROLATUM	NEW PRIDE CORP	f6634410-fa1f-7987-e053-2995a90abb06	2023-12-01	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair Balm	DIMETHICONE	Galderma Laboratories, L.P.	5efb3ef0-6ee9-4ef8-b81e-90bd1825c956	2023-11-30	Warnings	Exact identifier application number: M016
Cetaphil Cracked Skin Repair	DIMETHICONE	Galderma Laboratories, L.P.	27d74e0f-8359-4c59-bf7f-acade7f4545c	2023-11-30	Warnings	Exact identifier application number: M016
Sheffield Advanced Scar Gel	ADVANCED SCAR GEL	Sheffield Pharmaceuticals LLC	ab78b946-81ed-442c-a167-26c26c7fe8a1	2023-11-30	Warnings	Exact identifier application number: M016
Akin Diaper Rash	ZINC OXIDE	Southern Sales & Service, Inc.	f5515517-7977-48f9-aab6-cf0d2f2a04a0	2023-11-29	Warnings	Exact identifier application number: M016
Dr. Sheffield Diaper Rash	ZINC OXIDE	Sheffield Pharmaceuticals LLC	cac77320-b5cf-4edf-9693-ebabfb61390c	2023-11-28	Warnings	Exact identifier application number: M016
Sheffield Zinc Oxide	ZINC OXIDE	Sheffield Pharmaceuticals LLC	60b54c04-4387-4954-951d-165809947310	2023-11-28	Warnings	Exact identifier application number: M016
Cetaphil Baby Soothe and Protect Cream	ALLANTOIN	Galderma Laboratories, L.P.	38254e03-3716-4e45-86b7-06430ebadc86	2023-11-22	Warnings	Exact identifier application number: M016
Cetaphil Baby Eczema Soothing	COLLOIDAL OATMEAL	Galderma Laboratories, L.P.	d18aa7a8-15e3-4ca0-a501-fd11e8f7d85b	2023-11-22	Warnings	Exact identifier application number: M016
EczemaHoneyBodyLotion	COLLOIDAL OATMEAL	Allure Labs	0a710be0-562e-8368-e063-6294a90a3b1b	2023-11-18	Warnings	Exact identifier application number: M016
Zinc Oxide	SKIN PROTECTANT	BluePoint Laboratories	d9b752e6-655a-19a6-e053-2995a90a9a37	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL ORIGINAL PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	47b8c720-ad1e-4ac7-ba73-872e409b38bf	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL LAVENDER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	1ac9ee69-339d-4426-b3bf-13e5386f1a9b	2023-11-17	Warnings	Exact identifier application number: M016
UNIVERSAL COCOA BUTTER SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	cf888bf3-6950-43aa-b4be-5a32961b4d96	2023-11-15	Warnings	Exact identifier application number: M016
UNIVERSAL BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Universal Distribution Center LLC	b6e0ddb8-3761-482a-83d0-15d612d142eb	2023-11-15	Warnings	Exact identifier application number: M016
DERMA SANTE Anti Eczema Cream	OATMEAL	Hope Science Inc.	1492a6ad-016c-4307-8286-5c564de9e160	2023-11-11	Warnings	Exact identifier application number: M016
M3 NATURALS Eczema Cream	OATMEAL	M3 Naturals LLC	45e2cdde-58fb-4eea-a54d-f53f9ad0d854	2023-11-11	Warnings	Exact identifier application number: M016
THERAPLEX Eczema Therapy	OATMEAL	THERAPLEX, LLC	53900588-5c9e-4164-816d-017bdbb0f31b	2023-11-11	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Max Strength	ZINC OXIDE	Geodis Logistics LLC	1b4fd6cb-f2dc-40a2-b958-e99caec91793	2023-11-10	Warnings	Exact identifier application number: M016
Boudreauxs Butt Diaper Rash Original	ZINC OXIDE	Geodis Logistics LLC	97587458-4ca0-4de3-9bb9-148346d859c0	2023-11-10	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
204754	petrolatum 100 % Topical Jelly	PSN	34f3581f-39ba-4f28-9237-52f3820ab4c0	17
204754	petrolatum 1 MG/MG Topical Ointment	SCD	34f3581f-39ba-4f28-9237-52f3820ab4c0	17
204754	petrolatum 100 % Topical Jelly	SY	34f3581f-39ba-4f28-9237-52f3820ab4c0	17

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-068-01	53329006801	1 TUBE in 1 BOX (53329-068-01) / 28.4 g in 1 TUBE	1 tube	2018-01-01	0000-00-00	No	No	Current
53329-068-04	53329006804	118.29 g in 1 TUBE (53329-068-04)	118.29 g	2019-02-21	0000-00-00	No	No	Current
53329-068-16	53329006816	5 g in 1 PACKET (53329-068-16)	5 g	2018-01-01	0000-00-00	No	No	Current
53329-068-44	53329006844	113 g in 1 TUBE (53329-068-44)	113 g	2018-01-01	2022-01-01	No	No	Current
53329-068-96	53329006896	144 PACKET in 1 CARTON (53329-068-96) / 5 g in 1 PACKET (53329-068-16)	144 packet	2018-01-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
068 Curad Petroleum Jelly	Medline Industries, LP	2025-10-09	HUMAN OTC DRUG LABEL	17
ST COVID-POD (Saliva Collection Kit) - Asclemed USA, Inc.	Asclemed USA, Inc.	2020-09-23	HUMAN PRESCRIPTION DRUG LABEL	1