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		2026-10-15
excluded package	package	53329-068	53329-068-44	D	Discontinued by firm		2026-10-15

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 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 45 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aluroderm Scar	ALLANTOIN	Olakino Therapeutics LLC	2a848dde-8fc4-ab10-e063-6294a90a2583	2025-02-07	Warnings	Exact identifier application number: M016
Meijer Scar Gel	ALLANTOIN 0.5%	Meijer	c79352e9-d9a3-0d42-e053-2a95a90a5ea2	2025-02-06	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Family Dollar (FAMILY WELLNESS)	a2047ef3-cda4-4411-a4c2-d7fb03f5b069	2025-02-06	Warnings	Exact identifier application number: M016
First honey Burn Salve	ALLANTOIN	First Honey, LLC	f40a9a34-1827-7171-e053-2a95a90acf31	2025-02-04	Warnings	Exact identifier application number: M016
Manuka Honey Extra Strength	ALLANTOIN	First Honey LLC	b742585d-9a0c-489b-b268-590583cfabd1	2025-02-04	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Cardinal Health (Leader) 70000	36deb7de-14b0-44a4-89bb-51cc1770e65b	2025-02-04	Warnings	Exact identifier application number: M016
NIVAGEN ZINC OXIDE	ZINC OXIDE	Nivagen Pharmaceuticals, Inc.	7b42655b-2163-4637-9f5d-1d2efa1bdf1d	2025-02-03	Warnings	Exact identifier application number: M016
MATYS Baby ECZEMA RELIEF	COLLOIDAL OATMEAL	Matys Healthy Products LLC	4c052bed-0931-4b8d-b033-b1872272c598	2025-01-29	Warnings	Exact identifier application number: M016
MATYS Baby DIAPER RASH RELIEF	ZINC OXIDE	Matys Healthy Products LLC	f214db72-bf4f-46d7-8ffc-6333185a69d5	2025-01-29	Warnings	Exact identifier application number: M016
EARLY MOMMY Baby Bum Butta	ZINC OXIDE	TEKT TONE LABS LLC	4bd417ba-3d24-46e3-a771-3183824f0219	2025-01-28	Warnings	Exact identifier application number: M016
Rite Aid Scar	ALLANTOIN 0.5%	Rite Aid	fd152c8f-6df5-1236-e053-6394a90a865d	2025-01-27	Warnings	Exact identifier application number: M016
BIA Eczema Relief	OATMEAL	Codex Labs Corporation	2f2de819-b7db-4c1e-9d6e-9ce33f7e6d05	2025-01-27	Warnings	Exact identifier application number: M016
Geri-Gentle petrolatum	WHITE PETROLATUM	Geri-gentle corporation	0adfbb9e-173c-925a-e063-6394a90aeb5d	2025-01-25	Warnings	Exact identifier application number: M016
Royal Creamy Petroleum Jelly Cocoa Butter	PETROLATUM JELLY	Mission Series Inc. dba Prestige Beauty Care	aca24d5e-42ee-1606-e053-2a95a90ab4e6	2025-01-23	Warnings	Exact identifier application number: M016
Royal Creamy Petroleum Jelly	PETROLATUM JELLY	Mission Series Inc. dba Prestige Beauty Care	a903becc-443d-284b-e053-2a95a90a6c75	2025-01-23	Warnings	Exact identifier application number: M016
Pharmacys Prescription Petroleum Jelly	PETROLATUM	American Consumer Products Corp	c4d29ecb-bb00-cb0b-e053-2995a90a37ef	2025-01-23	Warnings	Exact identifier application number: M016
Baby XtraCare Oatmeal	DIMETHICONE	Rejoice International	0049462b-ff31-440f-9244-b61153625bca	2025-01-23	Warnings	Exact identifier application number: M016
Repair and Protect	PETROLATUM	Blistex Inc.	a51e1b67-e2c7-4b67-95db-07f5f3bdc068	2025-01-23	Warnings	Exact identifier application number: M016
Bebe Bottoms	ZINC OXIDE	TARO PHARMACEUTICALS U.S.A., INC.	eb8512db-f8a9-432c-8779-2971411ce43d	2025-01-21	Warnings	Exact identifier application number: M016
Johnsons First Touch Baby Gift Set	ZINC OXIDE	Kenvue Brands LLC	2c2337cf-4507-7232-e063-6294a90a79c3	2025-01-20	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