Puralube

Product NDC: 0574-4025
Requested package NDC: 0574-4025-35
11-digit product format: 005744025
Labeler code: 0574
Product ID: 0574-4025_d008be67-a4c2-4c8c-b6c2-021abd0f048a
Type: HUMAN OTC DRUG
Nonproprietary name: Light mineral oil, white petrolatum
Dosage form: OINTMENT
Route: OPHTHALMIC
Labeler: Paddock Laboratories, LLC
Application: part349
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2014-07-28
Marketing end: 2022-01-01
Substance: LIGHT MINERAL OIL; PETROLATUM
Active strength: 150 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 0000-00-00
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	0574-4025	0574-4025-35	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 · 12 matching rows.

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

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

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0574-4025-11	GM - Gram	0574-4025	4bc52665-7ab3-4004-83f5-a8f363c677b3	1	2018-08-13
0574-4025-20	GM - Gram	0574-4025	e2127896-6795-4474-8d11-e4d385e0c819	1	2014-09-03
0574-4025-35	GM - Gram	0574-4025	60cbd43d-c798-47ff-989e-609333bcb384	1	2015-02-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
LIGHT MINERAL OIL	ACTIVE INGREDIENT	N6K5787QVP	PURALUBE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [PADDOCK LABORATORIES, LLC]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	PURALUBE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [PADDOCK LABORATORIES, LLC]	1
LIGHT MINERAL OIL	ACTIVE MOIETY	N6K5787QVP	PURALUBE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [PADDOCK LABORATORIES, LLC]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	PURALUBE (LIGHT MINERAL OIL, WHITE PETROLATUM) OINTMENT [PADDOCK LABORATORIES, LLC]	1

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
N6K5787QVP	LIGHT MINERAL OIL	92062-35-6	LIGHT MINERAL OIL
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
0574-4025-35	00574402535	1 TUBE in 1 CARTON (0574-4025-35) > 3.5 g in 1 TUBE	1 tube	2015-01-05	2022-01-01	No	No	Current