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 25 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Kenkoderm Eczema Honey Soothing Body	KENKODERM ECZEMA HONEY SOOTHING BODY LOTION	Guangzhou Ariel Biotech Co., Ltd.	4865c697-05fc-eac8-e063-6294a90ae541	2026-01-14	Warnings	Exact identifier application number: M016
Gold Bond Medicated eczema relief	COLLOIDAL OATMEAL	Chattem, Inc.	52744c77-278f-40b1-a356-14ae4366389b	2026-01-14	Warnings	Exact identifier application number: M016
Water Drench Hyaluronic Healing Balm	DIMETHICONE	Peter Thomas Roth Labs, LLC	3f789176-1d80-d146-e063-6294a90a948a	2026-01-13	Warnings	Exact identifier application number: M016
DERMEDIAL Anti-Itch	OATMEAL, ZINC OXIDE	Saje Natural Business Inc	385dd757-740b-8324-e063-6294a90afeee	2026-01-13	Warnings	Exact identifier application number: M016
Sweet cheeks	ZINC OXIDE	Saje Natural Business Inc.	5fc6486e-8604-5c7b-e053-2991aa0a8d14	2026-01-13	Warnings	Exact identifier application number: M016
Teevodar	ALLANTOIN	PEER PHARM LTD.	57a1b6d1-9439-462b-aeb9-ef806e572eaf	2026-01-12	Warnings	Exact identifier application number: M016
Botao Baby Diaper Rash Cream	ZINC OXIDE	Peer Pharm Ltd.	df60a70e-e6c0-41b3-e053-2995a90af176	2026-01-12	Warnings	Exact identifier application number: M016
ECZEMA HAND RELIEF	COLLOIDAL OATMEAL	Skinfix, Inc.	0389bab7-04fb-7cfc-e063-6394a90a22d8	2026-01-12	Warnings	Exact identifier application number: M016
SKINFIX HAND REPAIR	OATMEAL	Skinfix, Inc.	1b65fc81-1b9e-4260-829a-332cf6891d02	2026-01-12	Warnings	Exact identifier application number: M016
ECZEMA INTENSIVE DAILY RELIEF BODY	COLLOIDAL OATMEAL CREAM	Skinfix, Inc.	0be3c631-bc9b-00a9-e063-6394a90abcbb	2026-01-12	Warnings	Exact identifier application number: M016
Sarna	COLLOIDAL OATMEAL	Crown Laboratories, Inc.	2d6b1872-9f4d-9eb3-e063-6394a90ab675	2026-01-12	Warnings	Exact identifier application number: M016
XIMONTH Nail Repairs Patches	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	47f1a711-5d6f-c023-e063-6294a90aa801	2026-01-09	Warnings	Exact identifier application number: M016
Endit zinc oxide skin protection	ZINC OXIDE	EndIt Laboratories, Inc.	e60bb0da-3349-f8f9-e053-2a95a90a9051	2026-01-09	Warnings	Exact identifier application number: M016
Endit Zinc Oxide Skin Protectant	ZINC OXIDE	Endit Laboratories, Inc.	55b3aa07-871d-421b-b76a-c2d359d6003f	2026-01-09	Warnings	Exact identifier application number: M016
Flanders Buttocks	WHITE PETROLATUM, ZINC OXIDE	Flanders Inc	32371159-c76d-41b0-e054-00144ff88e88	2026-01-09	Warnings	Exact identifier application number: M016
Pure Petrolatum Jelly	PETROLATUM	MY IMPORTS USA LLC	47da77ea-ab4e-fc3c-e063-6394a90a27b7	2026-01-08	Warnings	Exact identifier application number: M016
Z-Bum	DIAPER RASH CREAM	GM Pharmaceuticals, Inc	2a36f396-3a30-3f3f-e054-00144ff8d46c	2026-01-08	Warnings	Exact identifier application number: M016
Daily VLotion	DIMETHICONE	Kindra	1cc4b804-6483-68fd-e063-6294a90a38e4	2026-01-08	Warnings	Exact identifier application number: M016
V Relief Serum	DIMETHICONE	Kindra	1cd8a9e9-ac88-1799-e063-6294a90a3278	2026-01-08	Warnings	Exact identifier application number: M016
DR SMITHS DIAPER	ZINC OXIDE	Mission Pharmacal	7705b182-acf7-4195-9996-7d9fcdfbf055	2026-01-08	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