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		2026-10-28
excluded package	package	53329-067	53329-067-04	D	Discontinued by firm		2026-10-28

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 53 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
CVS Eczema Relief Skin Protectant	OATMEAL	CVS Health	3cf25c43-592f-41cb-aa0b-a82f4e7faf3d	2024-11-11	Warnings	Exact identifier application number: M016
DGH Advanced Formula Scar Skin Protectant	ALLANTOIN	Dolgencorp Inc	950dcffd-d2c3-4ca7-8a15-7cb1016ca364	2024-11-08	Warnings	Exact identifier application number: M016
ABC Arbonne Baby Care Diaper Rash	DIMETHICONE AND ZINC OXIDE	Arbonne International, LLC	dd1d8198-bb9d-4508-a971-ae3bc624cdd1	2024-11-08	Warnings	Exact identifier application number: M016
SUPER SENSITIVE DIAPER RASH	ZINC OXIDE	ORGANIC & SUSTAINABLE BEAUTY	b0de2a9b-7854-4caf-b7ff-632c1d4a382e	2024-11-08	Warnings	Exact identifier application number: M016
Dove	DERMASERIES ECZEMA RELIEF SOOTHING BODY LOTION	Conopco, Inc. d/b/a/ Unilever	bcfb12ea-304e-7d8c-e053-2a95a90af606	2024-11-07	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE ECZEMA FLARE-UP RESCUE THERAPY CREAM	Conopco, Inc. d/b/a/ Unilever	bd206830-e334-3764-e053-2995a90a74ca	2024-11-07	Warnings	Exact identifier application number: M016
Dove	MEN SKIN DEFENSE ANTIBACTERIAL 3N1 HAND BODY SHAVE BAR	Conopco Inc. d/b/a/ Unilever	b9e61a03-e000-50ab-e053-2a95a90a3210	2024-11-07	Warnings	Exact identifier application number: M016
Dove	DOVE CARE AND PROTECT ANTIBACTERIAL NOURISHING FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f8cb31-560c-79e0-e053-2a95a90a39ae	2024-11-07	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL HAND WASH	Conopco Inc. d/b/a/ Unilever	ed234413-777a-9c82-e053-2a95a90a6f98	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	CATCHING THE SUNRISE HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b9fa6c72-7c56-6fd0-e053-2995a90a6707	2024-11-07	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL FOAMING HAND WASH	Conopco Inc. d/b/a/ Unilever	ed24b320-27fc-9714-e053-2995a90a79a6	2024-11-07	Warnings	Exact identifier application number: M016
SKINSEI	ETHYL ALCOHOL LIQUID	Conopco Inc. d/b/a/ Unilever	a603c419-238f-0bae-e053-2a95a90abc2b	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	UNDER THE STARLIT SKY HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0dfe52-c550-94fd-e053-2995a90a9800	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SUMMERTIME SPRINKLERS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0e474c-db62-910f-e053-2995a90a889e	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	GIRLS NIGHT OUT HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ce03e-5e7b-b09a-e053-2995a90a4eef	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	AFTER THE RAIN HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0d27fb-f72f-5e87-e053-2a95a90af7e0	2024-11-07	Warnings	Exact identifier application number: M016
Love Beauty and Planet	BELOVED CATCUS FLOWER AND BASIL HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba47599c-3e11-cec3-e053-2a95a90aef7b	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	WRAPPED IN YOUR ARMS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0ef938-da18-3b9c-e053-2995a90acb72	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	SUNKISSED OCEAN WAVES HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0db6a3-222a-093f-e053-2a95a90ac88a	2024-11-07	Warnings	Exact identifier application number: M016
Find Your Happy Place	LAZY WEEKENDS HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	ba0f4571-e752-d925-e053-2995a90afd3a	2024-11-07	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