Pure Petroleum

Product NDC: 50346-001
11-digit product format: 503460001
Labeler code: 50346
Product ID: 50346-001_f0a92676-2545-457f-80c3-d2e24b83653d
Type: HUMAN OTC DRUG
Nonproprietary name: White Petroleum
Dosage form: JELLY
Route: TOPICAL
Labeler: Pan Aromas LLC
Application: part347
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2012-05-26
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 1 g/g
NDC exclude flag: E
Listing certified through: 2018-12-31
Current FDA listing: Historical FDA.report record

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 · 10 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	50346-001		I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-01	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-02	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-03	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-04	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-05	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-06	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-07	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-08	I	Inactivated by FDA	2026-10-05
excluded package	package	50346-001	50346-001-09	I	Inactivated by FDA	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 4 · 220 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-03	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-04	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-09	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-08	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-05	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-02	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-07	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	50346-001-06	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-03	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-04	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-09	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-08	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-05	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-02	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-07	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	50346-001-06	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-03	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-04	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-09	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-08	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-05	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-02	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-07	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	50346-001-06	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-03	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-04	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-09	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-08	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-05	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-02	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-07	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	50346-001-06	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-03	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-04	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-09	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-08	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-05	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-02	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-07	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	50346-001-06	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-03	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-04	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-09	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-08	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-05	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-02	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-07	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	50346-001-06	`cdf11ea48f46…`	`ba0047e9e063…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

FDA-Initiated Inactive NDC Indexing#

NDC, Related label table
NDC	Related label
50346-001-01	PURE PETROLEUM JELLY
50346-001-02	PURE PETROLEUM JELLY
50346-001-03	PURE PETROLEUM JELLY
50346-001-04	PURE PETROLEUM JELLY
50346-001-05	PURE PETROLEUM JELLY
50346-001-06	PURE PETROLEUM JELLY
50346-001-07	PURE PETROLEUM JELLY
50346-001-08	PURE PETROLEUM JELLY
50346-001-09	PURE PETROLEUM JELLY

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
50346-001-01	Pure Petroleum	100 g in 1 JAR	JELLY	100	1
50346-001-02	Pure Petroleum	113 g in 1 JAR	JELLY	113	1
50346-001-03	Pure Petroleum	142 g in 1 JAR	JELLY	142	1
50346-001-04	Pure Petroleum	170 g in 1 JAR	JELLY	170	1
50346-001-05	Pure Petroleum	198 g in 1 JAR	JELLY	198	1
50346-001-06	Pure Petroleum	226 g in 1 JAR	JELLY	226	1
50346-001-07	Pure Petroleum	255 g in 1 JAR	JELLY	255	1
50346-001-08	Pure Petroleum	283 g in 1 JAR	JELLY	283	1
50346-001-09	Pure Petroleum	368 g in 1 JAR	JELLY	368	1

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version	Uploaded
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	PURE PETROLEUM (WHITE PETROLEUM) JELLY [PAN AROMAS LLC]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	PURE PETROLEUM (WHITE PETROLEUM) JELLY [PAN AROMAS LLC]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
50346-001	PURE PETROLEUM (WHITE PETROLEUM) JELLY [PAN AROMAS LLC]	1	Legacy NDC, 9 package rows	20120530_eeaebd3b-2b23-4bf1-b130-93e1cf4591cc.zip

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	eeaebd3b-2b23-4bf1-b130-93e1cf4591cc	1
204754	petrolatum 1 MG/MG Topical Ointment	SCD	eeaebd3b-2b23-4bf1-b130-93e1cf4591cc	1
204754	petrolatum 100 % Topical Jelly	SY	eeaebd3b-2b23-4bf1-b130-93e1cf4591cc	1

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
50346-001-01	50346000101	100 g in 1 JAR	100 g	Historical
50346-001-02	50346000102	113 g in 1 JAR	113 g	Historical
50346-001-03	50346000103	142 g in 1 JAR	142 g	Historical
50346-001-04	50346000104	170 g in 1 JAR	170 g	Historical
50346-001-05	50346000105	198 g in 1 JAR	198 g	Historical
50346-001-06	50346000106	226 g in 1 JAR	226 g	Historical
50346-001-07	50346000107	255 g in 1 JAR	255 g	Historical
50346-001-08	50346000108	283 g in 1 JAR	283 g	Historical
50346-001-09	50346000109	368 g in 1 JAR	368 g	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
PURE PETROLEUM JELLY	Pan Aromas LLC \| Jell Pharmaceuticals Pvt. Ltd.	2012-05-26	HUMAN OTC DRUG LABEL	1