Remedy Skin Protectant

Product NDC: 53329-302
11-digit product format: 533290302
Labeler code: 53329
Product ID: 53329-302_efcfa488-6020-fcbd-e053-2995a90ad540
Type: HUMAN OTC DRUG
Nonproprietary name: White Petrolatum
Dosage form: PASTE
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2013-11-06
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 59 g/100g
NDC exclude flag: No
Listing certified through: 2023-12-31
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 · 3 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-302		D	Discontinued by firm	2026-11-13
excluded package	package	53329-302	53329-302-14	D	Discontinued by firm	2026-11-13
excluded package	package	53329-302	53329-302-41	D	Discontinued by firm	2026-11-13

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 · 6 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	53329-302-41	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-302-14	`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	53329-302-41	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-302-14	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
ALUMINUM STEARATES	INACTIVE INGREDIENT	O4D7U3B46U	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
CHLOROXYLENOL	INACTIVE INGREDIENT	0F32U78V2Q	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PARAFFIN	INACTIVE INGREDIENT	I9O0E3H2ZE	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PENTAERYTHRITYL DISTEARATE	INACTIVE INGREDIENT	697WOT8HNB	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
SORBITAN SESQUIOLEATE	INACTIVE INGREDIENT	0W8RRI5W5A	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
STEARIC ACID	INACTIVE INGREDIENT	4ELV7Z65AP	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
TOCOPHEROL	INACTIVE INGREDIENT	R0ZB2556P8	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
YELLOW WAX	INACTIVE INGREDIENT	2ZA36H0S2V	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1
ZINC OXIDE	INACTIVE INGREDIENT	SOI2LOH54Z	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-302	REMEDY SKIN PROTECTANT (WHITE PETROLATUM) PASTE [MEDLINE INDUSTRIES, LP]	6	Legacy NDC	20241207_0ec52309-642f-4667-9199-6711190fa1d4.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 39 of 67 · 1,323 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Rugby Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTION	Rugby Laboratories	9af3a740-ef97-26ce-e053-2a95a90a0ee1	2025-07-28	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	e7eb10b7-3950-49cb-ba73-11e7581b6be9	2025-07-25	Warnings	Exact identifier application number: M016
ProCure SkinGuard	PETROLATUM 49.9%	Twin Med LLC	3a1721f6-1bb0-cd47-e063-6394a90a148e	2025-07-25	Warnings	Exact identifier application number: M016
ProCure HydroCerin	PETROLATUM 33%	Twin Med LLC	3ab7248d-b914-9fdd-e063-6294a90ac4c8	2025-07-24	Warnings	Exact identifier application number: M016
AD PREVENT Original	AD PREVENT ORIGINAL	WellSpring Pharmaceutical Corporation	cf73246e-81c1-42e9-a107-dc6c99cf7d01	2025-07-24	Warnings	Exact identifier application number: M016
Dimethicone 1 Skin Protectant	DIMETHICONE	Universal Distribution Center LLC	2c5b96b9-24d6-4223-a63d-fe83d7c02368	2025-07-24	Warnings	Exact identifier application number: M016
Dr Butlers Soothing Incontinence	MINERAL OIL 59.8%, PETROLATUM 36.0%	Beyond Health PA	3a9d3796-fd05-fe57-e063-6294a90a0ac6	2025-07-23	Warnings	Exact identifier application number: M016
A and D plus E	VITAMIN A, D AND E OINTMENT	Derma Sciences Canada Inc.	35aca592-bfd0-652f-e063-6394a90ac53e	2025-07-22	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLATUM	Derma Sciences Canada Inc.	3a895e6c-da8d-db9b-e063-6394a90ace40	2025-07-22	Warnings	Exact identifier application number: M016
Petroleum Jelly	PETROLEUM JELLY	NeilMed Pharmaceuticals Inc.	36bbbb1e-78e9-98f6-e063-6294a90a66d1	2025-07-21	Warnings	Exact identifier application number: M016
Mountain Ice Eczema	COLLOIDAL OATMEAL	Mountainside Medical Equipment, Inc.	1a91f33e-dd85-4d5a-b61c-e460a507e292	2025-07-21	Warnings	Exact identifier application number: M016
Our Eczema Remedy	COLLOIDAL OATMEAL	Fewer Better Things	3a755b4c-47c8-9ca5-e063-6394a90af84a	2025-07-21	Warnings	Exact identifier application number: M016
Aveeno DAILY MOISTURIZING	DIMETHICONE	Kenvue Brands LLC	54a13b85-32b5-439d-a27a-8fba2cf44251	2025-07-16	Warnings	Exact identifier application number: M016
ProCure Moisture Barrier	1% DIMETHICONE, 12% ZINC OXIDE	Twin Med LLC	3988c83b-d4eb-1f09-e063-6394a90a45ad	2025-07-14	Warnings	Exact identifier application number: M016
Avalon Organics Antidandruff Conditioner	SALICYLIC ACID	The Hain Celestial Group, Inc.	66db1071-022a-aa19-e053-2a91aa0a8e39	2025-07-11	Warnings	Exact identifier application number: M016
Avalon Organics Antidandruff	SALICYLIC ACID	The Hain Celestial Group, Inc.	66c7f730-64f3-4eef-e053-2a91aa0a4225	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Infection Protection Wound Care Maximum Strength	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	9e7843e2-ca69-40f5-a4ce-da6b03ebe7f7	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Skin Repair	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	92a23c7f-6b89-49cb-93e2-49ab7a85c86d	2025-07-11	Warnings	Exact identifier application number: M016
terrasil Infection Protection Wound Care	ALLANTOIN	Aidance Scientific, Inc, DBA Aidance Skincare & Topical Solutions	e98d1d8c-c979-49de-9bd8-cd409efff6de	2025-07-11	Warnings	Exact identifier application number: M016
Neosporin Lip Health Overnight Renewal Therapy	PETROLATUM	Kenvue Brands LLC	0da54fe1-c99f-4a2d-9ee5-2dc24005096c	2025-07-10	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

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-302-14	53329030214	57 g in 1 TUBE (53329-302-14)	57 g	2013-11-06	0000-00-00	No	No	Current
53329-302-41	53329030241	169.5 g in 1 TUBE (53329-302-41)	169.5 g	2013-11-06	0000-00-00	No	No	Current