Soothe and Cool Free Moisture Barrier

Product NDC: 53329-072
11-digit product format: 533290072
Labeler code: 53329
Product ID: 53329-072_e9b0c006-8e8d-c5e5-e053-2995a90adb16
Type: HUMAN OTC DRUG
Nonproprietary name: Petrolatum
Dosage form: OINTMENT
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2007-01-01
Marketing end: 0000-00-00
Substance: PETROLATUM
Active strength: 93 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	53329-072		D	Discontinued by firm	2026-10-05
excluded package	package	53329-072	53329-072-16	D	Discontinued by firm	2026-10-05
excluded package	package	53329-072	53329-072-96	D	Discontinued by firm	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 1 · 33 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Code	Status	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-072-16	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-072-96	D	Discontinued by firm	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-072-16	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-072-96	I	Inactivated by FDA	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-072-16	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-072-96	I	Inactivated by FDA	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-072-16	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-072-96	I	Inactivated by FDA	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-072-16	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-072-96	I	Inactivated by FDA	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-072-16	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-072-96	I	Inactivated by FDA	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-072-16	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-072-96	I	Inactivated by FDA	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-072-16	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-072-96	I	Inactivated by FDA	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-072-16	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-072-96	I	Inactivated by FDA	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-072-16	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	53329-072-96	I	Inactivated by FDA	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-072-16	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	53329-072-96	I	Inactivated by FDA	`367a005e9d99…`	`383a685ebd0f…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53329-072-16	2024-07-30	072 Soothe and Cool® Moisture Barrier
53329-072-96	2024-07-30	072 Soothe and Cool® Moisture Barrier
53329-072-16	2024-01-30	072 Soothe and Cool® Moisture Barrier
53329-072-96	2024-01-30	072 Soothe and Cool® Moisture Barrier

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-072-16	GM - Gram	53329-072	76058714-78ee-4305-9591-ce9a23f5aa37	1	2019-08-06
53329-072-96	GM - Gram	53329-072	a5d31cf3-2ac0-4059-9601-659e2a74d3dc	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
BENZETHONIUM CHLORIDE	INACTIVE INGREDIENT	PH41D05744	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
ISOPROPYL MYRISTATE	INACTIVE INGREDIENT	0RE8K4LNJS	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-072	SOOTHE AND COOL FREE MOISTURE BARRIER (PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]	4	Legacy NDC	20220928_a143042d-5de5-4440-8750-2b56f3b817c6.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 3 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
DawnMist White Petrolatum	WHITE PETROLATUM	Dukal LLC	598e9d46-6450-af60-e063-6394a90a3a6b	2026-08-21	Warnings	Exact identifier application number: M016
MUSTELA Diaper Rash 1 2 3	ZINC OXIDE	Expanscience Laboratories d/b/a Mustela	163f388e-849d-4b7e-93c1-9045d77a9ec2	2026-08-21	Warnings	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	0073de92-585d-e01a-e063-6394a90a2ec2	2026-08-21	Warnings	Exact identifier application number: M016
Mederma PM	DIMETHICONE	L Perrigo Company	8c728904-28f4-4333-a9ea-20996fd1b007	2026-08-21	Warnings	Exact identifier application number: M016
Earths Care Hemorrhoid Relief	WITCH HAZEL AND MENTHOL, UNSPECIFIED FORM	DLC Laboratories, Inc.	e860d65b-126d-4d77-8003-9d1381849ab5	2026-08-20	Warnings	Exact identifier application number: M016
ClaraVie	PETROLATUM	Gentell LLC	596987e4-4205-b911-e063-6294a90aa570	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	ZINC OXIDE	Gentell LLC	596abd98-17d7-2a22-e063-6294a90af57d	2026-08-19	Warnings	Exact identifier application number: M016
Claravie Skin Repair Cream	DIMETHICONE	Gentell LLC	596ae269-172e-aef5-e063-6394a90a4e2a	2026-08-19	Warnings	Exact identifier application number: M016
Claravie	LANOLIN	Gentell LLC	596c1b73-e34d-c97d-e063-6394a90ada1b	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	MENTHOL, ZINC OXIDE	Gentell LLC	596c467f-a056-ea78-e063-6394a90a79f2	2026-08-19	Warnings	Exact identifier application number: M016
ClaraVie	LANOLIN	Gentell LLC	596fe32d-be34-0635-e063-6394a90a2fc0	2026-08-19	Warnings	Exact identifier application number: M016
Medpride	ZINC OXIDE	Shield Line LLC	e2689cae-e347-4c0b-825b-6281a0b7c2f1	2026-08-18	Warnings	Exact identifier application number: M016
Eczema Skin Relief Cream	COLLOIDAL OATMEAL	CVS Health	98fac854-f7b0-4c6e-888d-1bdc6b9323b9	2026-08-17	Warnings	Exact identifier application number: M016
Zinc Oxide	ZINC OXIDE	ADUSA Distribution, LLC	5940399c-31e3-6d51-e063-6294a90a8e7c	2026-08-17	Warnings, Adverse reactions	Exact identifier application number: M016
Intimate CareGel	HYALURONIC ACID	Guangzhou Yilong Cosmetics.,Ltd	5918d204-52db-e6d0-e063-6394a90ab78c	2026-08-14	Warnings	Exact identifier application number: M016
TENA Proskin protective cream	ZINC OXIDE	Essity HMS North America Inc.	b840377f-a297-4aff-900e-7ea8b7c98717	2026-08-13	Warnings, Adverse reactions	Exact identifier application number: M016
Medline	WHITE PETROLATUM, ZINC OXIDE	Medline Industries, LP	087d66ff-1a8c-dcb2-e063-6294a90a2f8c	2026-08-11	Warnings	Exact identifier application number: M016
Nail Renewal Liquid	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	581f7192-fc17-a706-e063-6394a90a3ffa	2026-08-11	Warnings	Exact identifier application number: M016
Intertrigo Relief Cream	GLYCERIN	Shantou South Moon Biotechnology Co., Ltd.	587220c9-0ae9-3438-e063-6394a90a0a86	2026-08-07	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	The Kroger Co.	9ddcd6ba-1aed-48f8-a91a-54bd6f0d9308	2026-08-06	Warnings, Adverse reactions	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
53329-072-16	53329007216	5 g in 1 PACKET (53329-072-16)	5 g	2007-01-01	0000-00-00	No	No	Current
53329-072-96	53329007296	144 PACKET in 1 CARTON (53329-072-96) > 5 g in 1 PACKET (53329-072-16)	144 packet	2007-01-01	0000-00-00	No	No	Current