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	2026-10-15
excluded package	package	53329-105	53329-105-14	D	Discontinued by firm	2026-10-15
excluded package	package	53329-105	53329-105-44	D	Discontinued by firm	2026-10-15
excluded package	package	53329-105	53329-105-87	D	Discontinued by firm	2026-10-15
excluded package	package	53329-105	53329-105-96	D	Discontinued by firm	2026-10-15

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 31 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Pediadermics eczema 3	COLLOIDAL OATMEAL, DIMETHICONE	Renu Laboratories, LLC	af861f0b-4387-6861-e053-2995a90a8bfa	2025-12-02	Warnings	Exact identifier application number: M016
Flexitol Face and Eyelid Eczema	OATMEAL	LaCorium Health USA Inc.	f5b24f9c-1a77-4dc3-b7fd-ccad7b06ee65	2025-12-02	Warnings	Exact identifier application number: M016
ProCure HydroShield	PETROLATUM 41%	Twin Med LLC	3d36e664-ac10-72eb-e063-6294a90a49c4	2025-12-01	Warnings	Exact identifier application number: M016
ProCure Vitamin A and D	WHITE PETROLATUM 93.4%	Twin Med LLC	3d385a07-2a12-fce7-e063-6294a90a32d6	2025-12-01	Warnings	Exact identifier application number: M016
ESTRIOL	ESTRIOL	Shenzhen Mengyue Technology Co., Ltd.	44de9eb4-080e-bfbc-e063-6394a90ac0ea	2025-12-01	Warnings	Exact identifier application number: M016
CareALL Creamy Petroleum Jelly	PETROLATUM	New World Imports, Inc	e13fea4e-bd6d-425a-aa7e-1d41dc36bf00	2025-12-01	Warnings	Exact identifier application number: M016
CareALL Creamy Cocoa Butter Petroleum Jelly	PETROLATUM	New World Imports, Inc	9358b8ef-df14-45fc-9bfd-9052577a1f88	2025-12-01	Warnings	Exact identifier application number: M016
CAREALL Zinc Oxide	ZINC OXIDE	New World Imports Inc	aa9ae4d1-4229-4894-9eaf-8588b2867472	2025-12-01	Warnings	Exact identifier application number: M016
CAREALL Petroleum	PETROLATUM	New World Imports, Inc	47e999de-08bd-4121-b6d0-270cc603b56d	2025-12-01	Warnings	Exact identifier application number: M016
HOEGOA Growth Hair Serum	GLYCERIN	Shantou Oralhoe Biotechnology Co., Ltd.	44b6609f-c58b-b6ac-e063-6394a90a749b	2025-11-29	Warnings	Exact identifier application number: M016
OUHOE Micro Darts Tag gone Patch	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	33ce447c-facd-35fb-e063-6394a90a1ead	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Herbal Hair Oil	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	30c3df30-e0c6-4efa-e063-6294a90ac40a	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Aloe Soothing Sun Cream	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	326781e0-55dc-80fc-e063-6394a90a09aa	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Ultra Anti-Acne Control Gel	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	3bd1b734-76b0-5264-e063-6294a90a32d0	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Lipoma Cream	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	3cb4aed1-3b13-a62a-e063-6294a90a6c39	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Para Crescimento	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	42fbfcac-29ab-51f7-e063-6394a90a626f	2025-11-27	Warnings	Exact identifier application number: M016
OUHOE Biotin With Hydrolyzed Collagen	GLYCERIN	Shantou Ouhoe Technology Co., Ltd.	43138915-5fe1-6e32-e063-6294a90abefa	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Pain Relief Patch	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3f835843-eb04-6273-e063-6294a90ab2f0	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Skin Tag Remover	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	32922508-74ae-8347-e063-6294a90a6154	2025-11-27	Warnings	Exact identifier application number: M016
EELHOE Bodyacne Removal Cleanser	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	3bbebf1d-2e22-1427-e063-6294a90a7999	2025-11-27	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