Medline

Product NDC: 53329-153
11-digit product format: 533290153
Labeler code: 53329
Product ID: 53329-153_5996485c-7ed2-ecdb-e063-6294a90ad807
Type: HUMAN OTC DRUG
Nonproprietary name: white petrolatum, zinc oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2023-05-01
Substance: ZINC OXIDE; WHITE PETROLATUM
Active strength: 150; 490 mg/g; mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Product NDC	Package NDC	Code	Status	Reporting period	Archive	Snapshot	Source SHA-256
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product	53329-153		I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-153	53329-153-44	I	Inactivated by FDA		excluded / ndc_excluded.zip	`f5e01cc5f278…`	`a2eaf40c39c3…`

Reported adverse events (FAERS/openFDA)#

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

Additional Listing Data#

Finished product: Yes
Brand name base: Medline
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	150 mg/g
WHITE PETROLATUM	490 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup
B6E5W8RQJ4	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1494207	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
0073de92-585d-e01a-e063-6394a90a2ec2	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
3c386306-c48a-413e-bb69-70cb268496f3	Product name	1	20210727

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
Effective	Related label
2025-09-03	153 Remedy Specialized Zinc Oxide Paste
2025-09-03	153 Remedy Specialized Zinc Oxide Paste
2025-09-03	153 Remedy Specialized Zinc Oxide Paste
2025-07-29	153 Remedy Specialized Zinc Oxide Paste
2025-07-29	153 Remedy Specialized Zinc Oxide Paste
2025-07-29	153 Remedy Specialized Zinc Oxide Paste

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
53329-153-44	Medline	113 g in 1 TUBE	PASTE	113		4

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-153-44	GM - Gram	53329-153	77ce5cc5-68f9-4fd8-9316-01c6e06c2d30	1	2024-07-12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-153	MEDLINE (WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]	2	Current NDC, 1 package rows	20231230_0073de92-585d-e01a-e063-6394a90a2ec2.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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydro Gel	GLYCERIN 20%	Trifecta Pharmaceuticals USA LLC	02e8e5d0-7844-39fe-e063-6394a90a57e1	2024-01-19	Warnings	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Sled Distribution, LLC	e73a4b7a-7b27-abfc-e053-2995a90a35c2	2024-01-15	Warnings	Exact identifier application number: M016
Sunmark Caldiphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	2024-01-12	Warnings	Exact identifier application number: M016
EIGHT HOUR NIGHT	DIMETHICONE	REVLON	b3b277f9-565a-636c-e053-2995a90a94d2	2024-01-12	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Eczema Relief Creamy	OATMEAL	L'Oreal USA Products Inc	bcf7b985-6875-4033-a412-1bb6d3afa6d8	2024-01-01	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing	PETROLATUM	L'Oreal USA Products Inc.	1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95	2023-12-31	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Baby Healing	PETROLATUM	L'Oreal USA Products Inc.	fe665bbc-1172-4f59-acc6-8d5c179693b6	2023-12-31	Warnings	Exact identifier application number: M016
Quality Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Market Association	e3c0c46d-3d85-411d-a543-009064cdd19e	2023-12-28	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Therapeutic Hand	DIMETHICONE	L'Oreal USA Products Inc	7fe49112-4180-415c-a380-768a8d6b2185	2023-12-28	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Pharma Nobis, LLC	e42fccc2-1b4e-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Pharma Nobis, LLC	e42fbdcc-3291-7761-e053-2995a90a7172	2023-12-26	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Pharma Nobis, LLC	e42fb807-8cb4-ed25-e053-2995a90a6780	2023-12-26	Warnings	Exact identifier application number: M016
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1494207	petrolatum 49 % / zinc oxide 15 % Paste	PSN	0073de92-585d-e01a-e063-6394a90a2ec2	4
1494207	petrolatum 0.49 MG/MG / zinc oxide 0.15 MG/MG Paste	SCD	0073de92-585d-e01a-e063-6394a90a2ec2	4
1494207	Petrolatum 0.49 MG/MG / ZNO 0.15 MG/MG Paste	SY	0073de92-585d-e01a-e063-6394a90a2ec2	4
1494207	petrolatum 49 % / zinc oxide 15 % Paste	SY	0073de92-585d-e01a-e063-6394a90a2ec2	4

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
53329-153-44	53329015344	113 g in 1 TUBE (53329-153-44)	113 g	2023-05-01	No	No	Current