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 20 of 67 · 1,323 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Daily Moisturizing	DIMETHICONE	Valu Merchandisers Company	0cccadd7-11f3-5d1f-e063-6294a90a55c4	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Valu Merchandisers Company	7c6fa37f-79b8-4409-b7a9-3f02332f887a	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	United Natural Foods, Inc. dba UNFI	014d0028-486e-4f1c-a14f-8162e393ebca	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	United Natural Foods, Inc. dba UNFI	29a3a719-5e8b-407d-b9d9-bdba26758292	2026-02-16	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Topco Associates LLC	8acb1b47-70ed-4aa2-a7c0-e807042affc7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Topco Associates LLC	2b32e720-ac71-4d60-bc06-e28a00f8a450	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Topco Associates LLC	3babe2cf-9e6c-4f22-940f-c1fdf489f1c7	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti Itch	PRAMOXINE HCL, ZINC ACETATE	Topco Associates LLC	8d3d1ff5-4868-495d-807c-e45aa2176f63	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Topco Associates LLC	b929b159-4af5-4a03-8e7c-676a6ba2bf55	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Topco Associates LLC	15d1ae3f-509c-4e6b-8f0c-cf9265680358	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Topco Associates LLC	cd7f1727-0b6e-4993-9820-43783994efa1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Topco Associates LLC	f37f17f7-f084-4b74-8361-178d2315a476	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Topco Associates LLC	4f6af42c-f41e-455f-b94b-3793bf0b9a3f	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	Topco Associates LLC	47e54eee-70e0-4bfa-ae77-d61a6560a9e1	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Topco Associates LLC	471a9f8d-ba12-41d3-a510-20c1a13ff850	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Wakefern Food Corp.	b799229b-f7ca-494c-afde-1fd096aef66e	2026-02-13	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	WinCo Foods, LLC	659cc8c7-6300-41c0-a684-c5fde7f2b100	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	Walgreen Co.	220f70e1-0802-4fe2-92d0-78dec557c993	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Walgreen Co.	417ae199-54bb-420f-a3cf-1c096062d78c	2026-02-12	Warnings, Adverse reactions	Exact identifier application number: M016
First Aid Beauty Dry Skin Rescue Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	4a93d029-d721-0bb5-e063-6294a90a17c4	2026-02-11	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