Soothe and Cool

Product NDC: 53329-067
11-digit product format: 533290067
Labeler code: 53329
Product ID: 53329-067_efceb3a5-8762-fb96-e053-2995a90a1c8f
Type: HUMAN OTC DRUG
Nonproprietary name: White 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: 935 mg/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 · 2 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Source date
excluded product	product	53329-067		D	Discontinued by firm		2026-10-23
excluded package	package	53329-067	53329-067-04	D	Discontinued by firm		2026-10-23

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 · 22 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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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	53329-067-04	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
a1367f07-14a3-4895-a6e7-61ee9285308b	Product name	1	20190415

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
53329-067-04	2024-07-30	C162847	48780-1	1030e365-1dcd-111a-e063-dadaa90a10e2	067 Soothe and Cool Protect A&D
53329-067-04	2024-01-30	C162847	48780-1	1030e365-1dcd-111a-e063-dadaa90a10e2	067 Soothe and Cool Protect A&D

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-067-04	GM - Gram	53329-067	ec3485a5-715b-4b22-84f8-bd555cc40374	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
Petrolatum	ACTIVE INGREDIENT	4T6H12BN9U	VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
Petrolatum	ACTIVE MOIETY	4T6H12BN9U	VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
Corn Oil	INACTIVE INGREDIENT	8470G57WFM	VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
Light Mineral Oil	INACTIVE INGREDIENT	N6K5787QVP	VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1
Vitamin A Palmitate	INACTIVE INGREDIENT	1D1K0N0VVC	VITAMINS A AND D OINTMENT (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-067	SOOTHE AND COOL (WHITE PETROLATUM) OINTMENT [MEDLINE INDUSTRIES, LP]	6	Legacy NDC	20221217_405163d3-c61d-4481-999a-b17ec33589d6.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 11 of 68 · 1,346 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Dove	ANTIBACTERIAL CARE MOISTURIZING CREAM	Conopco Inc. d/b/a/ Unilever	5150f48c-ff0c-ce39-e063-6394a90ad424	2026-05-08	Warnings	Exact identifier application number: M016
Seedlings Diaper Rash Cream	ZINC OXIDE	Young Living Essential Oils, LC.	4d8aeaba-ddb1-6f74-e054-00144ff88e88	2026-05-08	Warnings	Exact identifier application number: M016
Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5120b708-047a-1182-e063-6394a90a74c3	2026-05-06	Warnings	Exact identifier application number: M016
AOAO Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	512185a5-5c1d-ef9f-e063-6394a90a81af	2026-05-06	Warnings	Exact identifier application number: M016
AKOLKOL TOENAIL FUNGUS TREATMENT	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	5121c341-e5e9-2b36-e063-6394a90a93b8	2026-05-06	Warnings	Exact identifier application number: M016
Beyond Good Diaper Rash	ZINC OXIDE	Babylist, Inc	512b62df-4f08-d839-e063-6294a90ab52f	2026-05-06	Warnings	Exact identifier application number: M016
Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	4c531280-bc5b-1cf2-e063-6394a90a034a	2026-05-05	Warnings	Exact identifier application number: M016
PEGO Acne Buster Salicylic Acid Drying Serum	ZINC OXIDE,NIACINAMIDE,COLLOIDAL SULFUR,AZELAIC ACID,SALICYLIC ACID.	Guangzhou Senmai Biotechnology Co.,Ltd.	511eaced-c4d8-ae94-e063-6394a90a320e	2026-05-05	Warnings	Exact identifier application number: M016
Rugby Gas relief	SIMETHICONE	Rugby Laboratories	9b84f74f-8609-489d-b411-3103afa1b5c2	2026-05-04	Warnings	Exact identifier application number: M016
Vitamin A and D	PETROLATUM	Aldermed Inc.	3f13a15c-8b64-48f0-a459-853b9097bc31	2026-05-04	Warnings	Exact identifier application number: M016
Zinc Oxide Skin Protectant	ZINC OXIDE 20%	Aldermed Inc.	a55ac5b4-bac7-4d2a-8ac8-c3eaf7e89e52	2026-05-04	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Aldermed Inc.	4e02af41-db86-46d8-a97d-332d84eced6f	2026-05-04	Warnings	Exact identifier application number: M016
Daily Moisturizer	LOTION	Walgreens	fc65f673-b23d-1ffa-e053-6394a90a0966	2026-05-03	Warnings	Exact identifier application number: M016
Dry Skin Healing	PETROLATUM	Walgreen	0397507d-4b6e-c679-e063-6294a90a0b33	2026-05-03	Warnings	Exact identifier application number: M016
Daily Moisturizer	LOTION	Walgreen	fc67037a-ed31-f678-e053-6394a90a7175	2026-05-03	Warnings	Exact identifier application number: M016
Skin Relief	LOTION	Walgreen	fc678e80-e63d-e3fe-e053-6394a90aa7d6	2026-05-03	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Walmart INC	f76ceecc-ef11-3839-e053-6394a90a8d4a	2026-05-03	Warnings	Exact identifier application number: M016
Herpecin L	DIMETHICONE AND MERADIMATE AND OCTINOXATE AND OCTISALATE AND OXYBENZONE	Focus Consumer Healthcare, LLC	5b6ed4e9-3e69-c773-e053-2991aa0a7dfe	2026-05-01	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Retail Business Services, LLC	7291e175-a9b6-4c47-93ce-227ce11e4599	2026-04-30	Warnings, Adverse reactions	Exact identifier application number: M016
Herpecin Pain Relief	ALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCL	Focus Consumer Healthcare, LLC	beeb6043-6547-4fe9-e053-2995a90a5d74	2026-04-30	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
53329-067-04	53329006704	113 g in 1 TUBE (53329-067-04)	113 g	2007-01-01	0000-00-00	No	No	Current