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 10 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
EELHOE Cuticle Pusher Pen	GLYCERIN	Shantou Eelhoe Daily Chemical Technology Co., Ltd.	52c7f956-a2a1-ae1d-e063-6294a90ab3c2	2026-05-27	Warnings	Exact identifier application number: M016
Dermoia Eczema Relief Colloidal Oatmeal	OATMEAL	Treasurewise LLC	1285c0a4-5fdf-4691-a8c6-1de8e2e2f66a	2026-05-27	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Wal-Mart Stores, Inc.	61e76e2a-fc46-7a64-e053-2991aa0a56a8	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Wal-Mart Stores, Inc.	61929c97-bd6b-0d7c-e053-2991aa0aa571	2026-05-26	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Pharma Nobis, LLC	fbcfa541-beda-06de-e053-6294a90a9298	2026-05-26	Warnings	Exact identifier application number: M016
Humco Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Humco holding Group, Inc.	f7dcd959-fb98-43bb-8dd3-a662bf8a053c	2026-05-26	Warnings	Exact identifier application number: M016
Advanced Healing	PETROLATUM	CVS Pharamacy, Inc	0bd3380e-2284-44a7-b2ef-68c9909627fd	2026-05-26	Warnings, Adverse reactions	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing Lip Balm	PETROLATUM	L'Oreal USA Products Inc	21dc8842-0672-4d46-bcea-b8e3d54c48bf	2026-05-20	Warnings	Exact identifier application number: M016
AFTER CARE	DIMETHICONE	Merz North America	c19c5ffe-3b62-43e1-83c2-d89c7b9aa2ae	2026-05-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Trifecta Pharmaceuticals USA	63b551fc-7d16-c099-e053-2a91aa0a5f2c	2026-05-18	Warnings	Exact identifier application number: M016
ADVANCED SILICONE SCAR	ALLANTOIN	Yantai Aien Biotechnology Co., Ltd.	51ffdc45-5acf-ae20-e063-6294a90a55e8	2026-05-17	Warnings	Exact identifier application number: M016
LCFateLC Nail Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	51ea23f4-0a23-4ae1-e063-6394a90aa051	2026-05-16	Warnings	Exact identifier application number: M016
Radlive Active Defense Nano-Silver Cream	COLLOIDAL OATMEAL	SilverCeuticals	51e23135-008d-9db5-e063-6294a90a7d61	2026-05-15	Warnings	Exact identifier application number: M016
Cerave Developed with Dermatologists Healing	PETROLATUM	LOreal USA Products Inc	de44ac01-ba17-4f97-ac12-9ea348013bde	2026-05-14	Warnings	Exact identifier application number: M016
Triple 3x Max Diaper Rash	ZINC OXIDE	Advantice Health, LLC	e554046b-cd0a-4a6e-8f24-2e610c697432	2026-05-14	Warnings	Exact identifier application number: M016
Eczema Therapy	COLLOIDAL OATMEAL	SilverCeuticals	3a26a35e-a098-0e22-e063-6294a90a96b9	2026-05-13	Warnings	Exact identifier application number: M016
Nail- Pflaster	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	519681bc-6312-f627-e063-6394a90a2845	2026-05-11	Warnings	Exact identifier application number: M016
Hydrating	PETROLATUM	Aldermed Inc.	4aa6a354-e487-4b65-e063-6394a90abbf0	2026-05-09	Warnings	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Aldermed Inc.	4aa79292-dc91-b538-e063-6294a90ac3f0	2026-05-09	Warnings	Exact identifier application number: M016
XIMONTH Nail Fungus Care Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	514a998d-aa2a-46b6-e063-6294a90a6c22	2026-05-08	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