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 32 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EELHOE Skin Advanced Mole Remove Serum	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3efd75f9-438a-f811-e063-6394a90a9450	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Wart Remover	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3127d616-1933-e783-e063-6294a90a52f7	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Tanning Mist	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	32670243-957d-3a95-e063-6394a90a5893	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Skin Tag Patches	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3ddd3fb0-b824-0cde-e063-6394a90aea6a	2025-11-27	Warnings	Exact identifier application number: M016
WART REMOVER	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3fd47677-52c9-6d43-e063-6294a90aa45b	2025-11-27	Warnings	Exact identifier application number: M016
JAYSUING Hair Treatment Green Ginger	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	2e8e70de-a2e0-7a71-e063-6294a90a90b8	2025-11-27	Warnings	Exact identifier application number: M016
JAYSUING Liquid Wart Flat	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	3b0c05d1-a00e-97df-e063-6394a90af3d0	2025-11-27	Warnings	Exact identifier application number: M016
JAYSUING 7 Days Nail Fungus Treatment	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	2ef424cc-815a-b331-e063-6394a90aae70	2025-11-27	Warnings	Exact identifier application number: M016
JAYSUING Pain Relief Knee Patches	GLYCERIN	Shantou Jaysuing Cleaning and Environmental Protection Technology Co., Ltd.	358a3e81-abb5-0a65-e063-6294a90a3d69	2025-11-27	Warnings	Exact identifier application number: M016
Sandra Plasencia PDRN Rejuvenating Serum	RH-OLIGOPEPTIDE-1	Guangzhou Meijiao Medical Biotechnology Co., Ltd.	449634c8-ff99-1387-e063-6294a90aef45	2025-11-27	Warnings	Exact identifier application number: M016
GLUTATHIONE	KOJIC ACIDSKIN LIGHTENING	HANCHOYEANBIOTEC Co.,Ltd.	2be274be-e6d0-d961-e063-6294a90a2190	2025-11-27	Warnings	Exact identifier application number: M016
XIMONTH Bee Venom Joint Cream	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	33d18888-8d06-da13-e063-6294a90a743c	2025-11-26	Warnings	Exact identifier application number: M016
XIMONTH Bee Venom Wart Remover Patch	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	3e6965b6-8f08-db62-e063-6394a90a64c9	2025-11-26	Warnings	Exact identifier application number: M016
XIMONTH GLP-1 Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	3d03cdfd-2e9e-f9a1-e063-6394a90a6a8b	2025-11-26	Warnings	Exact identifier application number: M016
XIMONTH Bee Venom Repair	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	37e40cc1-1121-1eee-e063-6294a90aab26	2025-11-26	Warnings	Exact identifier application number: M016
XIMONTH Liquid Wart Corn Callus Remover	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	3a1b872a-2883-0b70-e063-6294a90af9d6	2025-11-26	Warnings	Exact identifier application number: M016
XIMONTH Jimerito Honey For Eyes	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	3aa38704-4d2b-ffaf-e063-6294a90a323e	2025-11-26	Warnings	Exact identifier application number: M016
XIMONTH Bee Honey Eye Drops	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	3e69c950-bbbc-5c47-e063-6294a90a070e	2025-11-26	Warnings	Exact identifier application number: M016
Boudreauxs	ZINC OXIDE	C.B. Fleet Company, Inc.	4c7e832e-55f3-4766-98b7-29b17d741a4b	2025-11-26	Warnings	Exact identifier application number: M016
Johnsons Baby Care Essentials Gift Set	ZINC OXIDE	Kenvue Brands LLC	43edc287-57e1-d96e-e063-6294a90ac5a1	2025-11-24	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