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 9 of 70 · 1,384 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
SUPRADERM	WHITE PETROLATUM, LANOLIN	Olen Skin Care Corporation	4e7199bd-52c6-48e9-9c78-c84e45412faf	2026-06-10	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	509ee758-9d53-220c-e063-6394a90a4bd5	2026-06-09	Warnings	Exact identifier application number: M016
BABY BUM DIAPER	ZINC OXIDE	Creative Consumer Products, Inc. DBA (Doing Business As) Dionis Goat Milk Skincare	53d8a654-aaec-6f91-e063-6394a90a7351	2026-06-09	Warnings	Exact identifier application number: M016
CELISTAR MICRONEEDLING INFUSION	HYALURONATE SODIUM	Guangdong Outeli Biotechnology Co., Ltd.	53de46a7-3947-70a7-e063-6294a90ab829	2026-06-09	Warnings	Exact identifier application number: M016
Medline	DIMETHICONE	Medline Industries, LP	3c448cf7-8ca5-c7f7-e063-6294a90a75ff	2026-06-08	Warnings	Exact identifier application number: M016
WOODSLEEP Wild Yam Cream	GLYCERIN	Shantou Woodsleep Biotechnology Co., Ltd.	53b992fd-5759-57bb-e063-6394a90a1600	2026-06-08	Warnings	Exact identifier application number: M016
XIMONTH Fungi Free Bee Venom Nail Soothing Serum	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	53bab969-8407-6334-e063-6294a90aa5d1	2026-06-08	Warnings	Exact identifier application number: M016
GNP Calamine Topical Suspension	CALAMINE 8% AND ZINC OXIDE 8%	Amerisource Bergen	777b0e66-1bce-4483-9dad-c46796fd6f23	2026-06-04	Warnings	Exact identifier application number: M016
GNP Caldyphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Amerisource Bergen	515c58d7-0dc4-45e7-9155-e5270a16290e	2026-06-04	Warnings	Exact identifier application number: M016
First Aid Beauty Sensitive Skin Bestsellers Kit	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	535a0e8e-6bb4-6652-e063-6394a90aa7ff	2026-06-03	Warnings	Exact identifier application number: M016
Quad Wash	DIMETHICONE	Dynarex Corporation	535dc862-6a18-26c9-e063-6294a90a3d4a	2026-06-03	Warnings	Exact identifier application number: M016
First Aid Beauty Sensitive Skin Bestsellers Kit	COLLOIDAL OATMEAL	JCS Global Distribution, Inc.	535e42a1-8b14-324d-e063-6394a90a3f65	2026-06-03	Warnings	Exact identifier application number: M016
Petroleum Jelly Skin Protectant	WHITE PETROLATUM	Acme United Corporation	535e94bb-21e8-90be-e063-6394a90a37bb	2026-06-03	Warnings	Exact identifier application number: M016
ADVANCED HEALING	PETROLATUM	Rejoice International Corp.	532c7e5a-4d05-3bd0-e063-6294a90aee00	2026-06-01	Warnings	Exact identifier application number: M016
PUTRIZEN 40 UREA	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	533dadbc-6f20-d880-e063-6394a90a753f	2026-06-01	Warnings	Exact identifier application number: M016
ADVANCED HEALING BALM	PETROLATUM	Rejoice International Corp.	53285d82-3755-ca78-e063-6394a90a5019	2026-05-31	Warnings	Exact identifier application number: M016
KIEHLS SINCE 1851 Ultra Facial Meltdown Recovery	COLLOIDAL OATMEAL	LOreal USA Products Inc	22e088b9-b3b1-4c34-be12-a5a31200ec25	2026-05-29	Warnings	Exact identifier application number: M016
Acne Relief Cream	NIACINAMIDE,SALICYLIC ACID,CENTELLA ASIATICA ROOT,COPTIS CHINENSIS ROOT	Guangzhou Senmai Biotechnology Co.,Ltd.	53008b89-89ab-7650-e063-6294a90ac16c	2026-05-29	Warnings	Exact identifier application number: M016
PURE PETROLATUM	PETROLATUM	VASA COSMETICS PRIVATE LIMITED	52efd466-49bd-bbdf-e063-6394a90aa108	2026-05-28	Warnings	Exact identifier application number: M016
TheraCare Vitamin A and D plus E	PETROLATUM	Veridian Healthcare	52e0e248-6c04-feb9-e063-6394a90add46	2026-05-28	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
53329-072-16	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