Soothe and Cool Protect

Product NDC: 53329-993
Requested package NDC: 53329-993-04
11-digit product format: 533290993
Labeler code: 53329
Product ID: 53329-993_efe1a0f9-ed14-54d7-e053-2a95a90afb80
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
Dosage form: JELLY
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2019-04-01
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 1 g/g
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 · 1 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded package	package	53329-993	53329-993-04	D	Discontinued by firm		2026-10-21

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-993	53329-993-04	D	Discontinued by firm		excluded / ndc_excluded.zip	`d630ba8d3edf…`	`732f749b63fb…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-993	53329-993-04	I	Inactivated by FDA		excluded / ndc_excluded.zip	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53329-993-04	2024-10-23	C162847	48780-1	1030e365-6750-111a-e063-dadaa90a10e2	993 Sooth & Cool Protect white petrolatum
53329-993-04	2024-07-30	C162847	48780-1	1030e365-6750-111a-e063-dadaa90a10e2	993 Sooth & Cool Protect white petrolatum
53329-993-04	2024-01-30	C162847	48780-1	1030e365-6750-111a-e063-dadaa90a10e2	993 Sooth & Cool Protect white petrolatum

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-993	SOOTHE AND COOL PROTECT (PETROLATUM) JELLY [MEDLINE INDUSTRIES, LP]	4	Legacy NDC	20241025_9a008bb9-5630-fdd8-e053-2995a90a9d33.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 68 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Anubis Barcelona New Even	LACTIC ACID, CITRIC ACID, GLYCOLIC ACID	ANUBIS COSMETICS SL	eaeeb6e0-5322-20c4-e053-2995a90a9fd9	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED COLLAGEN	ANUBIS COSMETICS SL	f564bbf0-3b5c-4a81-e053-2a95a90a7ea6	2023-08-29	Warnings	Exact identifier application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15	CAMPHOR (SYNTHETIC), PETROLATUM	Carma Laboratories, Inc.	5378d653-702d-405c-a067-882554aaf93a	2023-08-21	Warnings	Exact identifier application number: M016
Quality Choice Anti-itch Medicated	CALAMINE AND PRAMOXINE HYDROCHLORIDE	CHAIN DRUG MARKETING ASSOCIATION INC	5e07f26f-cfb6-57f9-e053-2991aa0a2008	2023-08-02	Warnings	Exact identifier application number: M016
Barrier Balm	BARRIER BALM	Autumn Harp, Inc.	01df9746-991b-4363-e063-6294a90aaac6	2023-08-01	Warnings	Exact identifier application number: M016
Barrier Cream	ZINC OXIDE	Avasol LLC	bc6a2736-faa6-46d3-af9b-a70f0762e9ce	2023-05-15	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy Cane	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	bec2f702-5ff5-ea66-e053-2a95a90ad1ec	2023-01-01	Warnings	Exact identifier application number: M016
Badger After-BUG Balm	COLLOIDAL OATMEAL	W.S. Badger Company, Inc.	a623da47-cef2-146f-e053-2a95a90afe3a	2021-11-17	Warnings	Exact identifier application number: M016
Derma-e Eczema Relief	OATMEAL	Topiderm, Inc	e1797f81-af4b-49e1-9906-dbfd904a282b	2020-08-19	Warnings	Exact identifier application number: M016
Resurfix Plus	PETROLATUM	Topiderm, Inc.	f100f43d-6ace-4c3a-9c85-640c0ab2e360	2019-11-19	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
53329-993-04	53329099304	113 g in 1 TUBE (53329-993-04)	113 g	2019-04-01	0000-00-00	No	No	Current

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
993 Sooth & Cool Protect white petrolatum	Medline Industries, LP	2024-10-23	HUMAN OTC DRUG LABEL	4