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		2026-10-05
excluded package	package	53329-068	53329-068-44	D	Discontinued by firm		2026-10-05

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 1 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dermaka Infants and Kids Multi Purpose Skin Protectant	ZINC OXIDE	Dermaka Skin Products LLC	f84dfd55-db6c-4d75-be67-4d13a139e209	2026-09-10	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Soothing Therapeutic Multipurpose	DIMETHICONE	L'Oreal USA Products Inc	805cd262-2689-4818-8fed-ddefacbdde23	2026-09-10	Warnings	Exact identifier application number: M016
La Roche Posay Laboratoire Dermatologique Cicaplast Balm B5 Therapeutic Multipurpose	DIMETHICONE	Cosmetique Active Production	d19f482c-bec7-45aa-b22f-fe91a3dc717d	2026-09-10	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	CVS Pharmacy, Inc.	35e67726-4527-4cd7-8e73-30325a32402c	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Lanolin, Petrolatum	LANOLIN, PETROLATUM	CVS Pharmacy, Inc.	606f65a8-08fd-4ab6-9d68-03ddf662bdf0	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Soothing Moisturizing Cream	COLLOIDAL OATMEAL	Nice-Pak Products, LLC	23548524-2e2e-4d1a-9ebb-6f86d6279e93	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walgreen Co.	22bd8e87-965c-466b-bb9b-7d4753e500bc	2026-09-09	Warnings, Adverse reactions	Exact identifier application number: M016
Drs. pharmacy Scar Cream	ALLANTOIN	OL PHARMA TECH, LLC Drs PHARMACY	d0381034-8cf7-5e8d-e053-2995a90a9faa	2026-09-09	Warnings	Exact identifier application number: M016
Drs. Pharmacy baby healing	PETROLATUM	OL PHARMA TECH, LLC Drs PHARMACY	5b14ffa0-9486-a7fe-e063-6394a90ab3ed	2026-09-09	Warnings	Exact identifier application number: M016
Wart Remover	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	5af3afe1-dad5-91b7-e063-6294a90ab95e	2026-09-08	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	5afb3595-f014-153e-e063-6294a90ad34b	2026-09-08	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	5afb59b4-491c-45bb-e063-6294a90a0ae6	2026-09-08	Warnings	Exact identifier application number: M016
Claravie	ALUMINUM HYDROXIDE GEL	Gentell LLC	5afea757-8feb-f907-e063-6394a90a6259	2026-09-08	Warnings	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	United Natural Foods, Inc. dba UNFI	242adc68-f9e0-4f69-a580-a107d1634b50	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	United Natural Foods, Inc. dba UNFI	0bc1a9b4-1210-4d9a-bbd2-40e9225e86ea	2026-09-04	Warnings, Adverse reactions	Exact identifier application number: M016
FIRST AID BEAUTY FAB ULTRA REPAIR SKIN PROTECTANT Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5a9aaca8-474a-0393-e063-6394a90a5a3a	2026-09-04	Warnings	Exact identifier application number: M016
Aveeno Eczema Therapy Cream	COLLOIDAL OATMEAL	Kenvue Brands LLC	5a7b0470-3ed5-5b92-e063-6294a90ae0f4	2026-09-03	Warnings	Exact identifier application number: M016
First Aid Beauty Face and Body Bestsellers Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	5a974dbf-84ac-5374-e063-6294a90a8da0	2026-09-03	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	Jell Pharmaceuticals Pvt. Ltd.	cdc297cb-476a-6da9-e053-2a95a90a399a	2026-09-02	Warnings	Exact identifier application number: M016
Nail Treatment Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5a7cd607-a50e-17d0-e063-6294a90acdb2	2026-09-02	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