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		2026-10-27
excluded package	package	53329-067	53329-067-04	D	Discontinued by firm		2026-10-27

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 43 of 68 · 1,343 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Gold Bond Eczema Relief Medicated Hand Cream	COLLOIDAL OATMEAL	Chattem, Inc.	27457bc5-3edc-4c8b-b8a2-eaf09b511cf8	2025-03-19	Warnings	Exact identifier application number: M016
Nicotine Patches	NICOTINE PATCHES	Zhejiang FTA Shengzuozhi Biotechnology Co., LTD	30a977c3-6862-670e-e063-6294a90aeb2f	2025-03-18	Warnings	Exact identifier application number: M016
YVTYVT Copper Peptides Face Serum	COPPER TRIPEPTIDE-1	Beijing JUNGE Technology Co., Ltd.	306f2d48-43b8-359a-e063-6394a90a06dc	2025-03-16	Boxed warning, Warnings	Exact identifier application number: M016
Dr Talbots Cooling Perineal Pad	WATER, ALOE BARBADENSIS LEAF JUICE, BIOFLAVONOIDS, CALENDULA OFFICINALIS FLOWER EXTRACT, CHAMOMILLA RECUTITA FLOWER EXTRACT, CITRIC ACID, DECYL GLUCOSIDE, GLYCERIN, LACTIC ACID, LEVULINIC ACID, MENTHA PIPERITA (PEPPERMINT) OIL, SODIUM COCOAMPHOACETATE, POTASSIUM SORBATE	Talbot's Pharmaceuticals family Products, LLC.	242277e2-ff26-ad4e-e063-6394a90ab317	2025-03-14	Warnings	Exact identifier application number: M016
RID Poison Ivy Rash Relief	CALAMINE AND ZINC OXIDE	Oystershell Consumer Health Inc.	36c3af9a-2646-4427-e063-6394a90a2c5e	2025-03-13	Warnings	Exact identifier application number: M016
Aavini Double Layer Brightening Spot Correcting Essence Oil	AAVINI DOUBLE LAYER BRIGHTENING SPOT CORRECTING ESSENCE OIL	Qingyuan Moksha Biotechnology Co., Ltd.	2ff89a13-3969-2df1-e063-6394a90ac0d3	2025-03-10	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	3008bbeb-abba-5cdb-e063-6294a90ae483	2025-03-10	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Cream Intense Hydration Skin Protectant Cucumber Melon	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2fc4745c-fac9-7861-e063-6294a90a3f14	2025-03-07	Warnings	Exact identifier application number: M016
AD Skin Protectant	AD SKIN PROTECTANT	WellSpring Pharmaceutical Corporation	d26f1312-2e1b-4106-bc48-a336d4e034ad	2025-03-07	Warnings	Exact identifier application number: M016
Aveeno Baby Eczema Therapy Nighttime Balm	OATMEAL	Kenvue Brands LLC	04d90e45-c2ee-4122-b919-a0eb6d11b59a	2025-03-04	Warnings	Exact identifier application number: M016
5% Signature Numb cream	5% SIGNATURE	Shengnan (Guangzhou) Cosmetics Co., LTD	2f80abc0-49d8-968d-e063-6294a90a555b	2025-03-04	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Intense Hydration Skin Protectant Vanilla	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	f19b3056-063c-63ec-e053-2995a90a4614	2025-03-04	Warnings	Exact identifier application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Peppermint Twist	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	2770424d-7414-66d4-e063-6394a90ad4b1	2025-03-04	Warnings	Exact identifier application number: M016
Olay Sensitive Soothing Moisturizer Skin Protectant Fragrance-Free	COLLOIDAL OATMEAL	The Procter & Gamble Manufacturing Company	026bb3a1-3e01-1530-e063-6294a90ab1b1	2025-03-04	Warnings	Exact identifier application number: M016
5% Dr.care Numb cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	2f905d76-ef9c-c844-e063-6394a90a4dc9	2025-03-04	Warnings	Exact identifier application number: M016
Desitin Maximum Strength Zinc Oxide Diaper Rash	ZINC OXIDE	Kenvue Brands LLC	1590101a-c968-fca5-e063-6394a90a7ccc	2025-02-28	Warnings	Exact identifier application number: M016
Perineal Cooling Liners	WITCH HAZEL	CVS Pharmacy	88f44650-8fb7-4eb2-901d-30eb8415dc2b	2025-02-25	Warnings	Exact identifier application number: M016
5% Signature Numb cream	LIDOCAINE	Shengnan (Guangzhou) Cosmetics Co., LTD	2f043d3c-d8db-414e-e063-6394a90a13de	2025-02-25	Warnings	Exact identifier application number: M016
Hania Skin Protectant	PETROLATUM	Natureplex LLC	63609a57-91fc-4cfd-b942-b69a0d2fb284	2025-02-19	Warnings	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Whole Foods Market	2c55ca28-61b1-4b3a-bba8-11acd1273bd3	2025-02-19	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
53329-067-04	53329006704	113 g in 1 TUBE (53329-067-04)	113 g	2007-01-01	0000-00-00	No	No	Current