Medline Remedy Phytoplex Calazime

Product NDC: 53329-105
11-digit product format: 533290105
Labeler code: 53329
Product ID: 53329-105_e9b161c1-845b-b9bc-e053-2995a90a0ce3
Type: HUMAN OTC DRUG
Nonproprietary name: menthol, zinc oxide, petrolatum
Dosage form: PASTE
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2018-07-09
Marketing end: 0000-00-00
Substance: MENTHOL; PETROLATUM; ZINC OXIDE
Active strength: 44 g/100g; g/100g; 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 · 5 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	53329-105		D	Discontinued by firm	2026-10-16
excluded package	package	53329-105	53329-105-14	D	Discontinued by firm	2026-10-16
excluded package	package	53329-105	53329-105-44	D	Discontinued by firm	2026-10-16
excluded package	package	53329-105	53329-105-87	D	Discontinued by firm	2026-10-16
excluded package	package	53329-105	53329-105-96	D	Discontinued by firm	2026-10-16

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	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-105-44	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-105-96	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-105-14	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	53329-105-87	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-105-96	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-105-14	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	53329-105-87	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-105-96	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	53329-105-87	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-105-96	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	53329-105-87	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-105-96	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	53329-105-87	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-105-96	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	53329-105-87	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-105-96	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	53329-105-87	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-105-96	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	53329-105-87	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-105-96	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	53329-105-87	`0efc9e666f02…`	`f202fb6c5f17…`

Reported adverse events (FAERS/openFDA)#

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

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-105-44	GM - Gram	53329-105	56e05dfd-798e-4caa-a0bd-666739d41dbe	1	2023-04-07

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-105	MEDLINE REMEDY PHYTOPLEX CALAZIME (MENTHOL, ZINC OXIDE, PETROLATUM) PASTE [MEDLINE INDUSTRIES, LP]	7	Legacy NDC	20240130_6dd75810-da93-28aa-e053-2a91aa0a0dab.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 49 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Savvy Itch Stopping	DIPHENHYDRAMINE HYDROCHLORIDE ZINC ACETATE	Savvy Care and Cosmetics	05ee2662-6a51-6e49-e063-6294a90a4ed7	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Lavender Baby Petroleum	WHITE PETROLEUM	Home Smart Products	5828df37-2a42-4129-8e4e-d5ac9c4c9615	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	980d030a-feaf-4a81-865e-f85c66151380	2024-12-19	Warnings	Exact identifier application number: M016
Baby Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	caf568aa-3889-41ff-835e-875bb6d9ca79	2024-12-19	Warnings	Exact identifier application number: M016
Petroleum Jelly	WHITE PETROLATUM	Rejoice International Inc.	a45eb8aa-9fc9-4332-a3ef-0e6fd348fb95	2024-12-19	Warnings	Exact identifier application number: M016
Cars Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	9905b5a4-382e-4d2a-b971-37998c14c330	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Aloe Vera Petroleum	WHITE PETROLEUM	Home Smart Products	2671f2ed-af9d-4234-95bf-def368242a78	2024-12-19	Warnings	Exact identifier application number: M016
DCH Scar	ALLANTOIN 0.5%	Derma Care Research Labs, LLC	00edbc64-9d32-5751-e063-6294a90a400b	2024-12-19	Warnings	Exact identifier application number: M016
Bamboobies Diaper Rash	ZINC OXIDE 15%	Derma Care Research Labs, LLC	0411f5e3-03d2-c512-e063-6394a90a37d3	2024-12-19	Warnings	Exact identifier application number: M016
Maximum Strength Medicated Foot Powder	MEDICATED FOOT POWDER	Jell Pharmaceuticals Pvt. Ltd.	cdaae985-5363-e9d2-e053-2995a90a2682	2024-12-18	Warnings	Exact identifier application number: M016
BABY FRESH SCENT PETROLEUM	WHITE PETROLEUM	Jell Pharmaceuticals Pvt Ltd.	d80d21cf-9463-7184-e053-2995a90a23f3	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Baby Petroleum	WHITE PETROLEUM	Home Smart Products	edd9d018-c2c9-4a9a-b727-0a92cd463c02	2024-12-18	Warnings	Exact identifier application number: M016
Health Smart Cocoa Butter Petroleum	WHITE PETROLEUM	Home Smart Products	a65c8267-d34f-4542-a7ca-5180e860a03d	2024-12-18	Warnings	Exact identifier application number: M016
Princess Petroleum	WHITE PETROLATUM	Ultra Distributors Inc.	6d9c92bf-9263-40a4-acac-5c3f0b08c69d	2024-12-18	Warnings	Exact identifier application number: M016
Meijer Petroleum Jelly	WHITE PETROLATUM	Meijer Distribution, Inc	b299cf2a-2c6a-68f4-e053-2995a90a5bd7	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services, LLC	29945734-4ea6-b702-e063-6294a90ae6f2	2024-12-18	Warnings	Exact identifier application number: M016
Foster and Thrive Caldyphen Clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Strategic Sourcing Services, LLC	29946912-9794-8a8e-e063-6394a90a279e	2024-12-18	Warnings	Exact identifier application number: M016
Caring Mills Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	fbbfa780-0e2b-1874-e053-6394a90a5eeb	2024-12-18	Warnings	Exact identifier application number: M016
Serawise Eczema Rescue	OATMEAL	DrAnaMaria.com LLC	e805866a-2349-4b86-bc83-a7c859cb9403	2024-12-18	Warnings	Exact identifier application number: M016
TheraCare Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	d6fad49b-8a49-7f7c-e053-2a95a90ae638	2024-12-18	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
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-105-14	53329010514	57 g in 1 TUBE (53329-105-14)	57 g	2018-07-09	0000-00-00	No	No	Current
53329-105-44	53329010544	113 g in 1 TUBE (53329-105-44)	113 g	2018-07-09	0000-00-00	No	No	Current
53329-105-87	53329010587	4 g in 1 PACKET (53329-105-87)	4 g	2018-07-09	0000-00-00	No	No	Current
53329-105-96	53329010596	144 PACKET in 1 CARTON (53329-105-96) > 4 g in 1 PACKET (53329-105-87)	144 packet	2018-07-09	0000-00-00	No	No	Current