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 17 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Old East Main Co.	91df1434-bce6-4c6e-beee-cb5ec1cc8fff	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Old East Main Co.	cf916191-1de2-4305-b783-9e074c1ad94b	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Eczema Relief	COLLOIDAL OATMEAL	Old East Main Co.	b2dba027-c295-4a41-8d30-144904e1aa34	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Eczema Therapy	COLLOIDAL OATMEAL	Old East Main Co.	9720e2ad-1bcf-4023-8e92-22a962df3aad	2026-03-02	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Chain Drug Marketing Association	86ff4875-9007-4b7b-8f46-16cbd475d4bb	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Chain Drug Marketing Association	1ff6bd85-3658-47ea-b6ca-0eb5d8dbb693	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Chain Drug Marketing Association	6c848b98-f01c-40f2-a9aa-2af76cb370c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	The Kroger Co.	fcffbe1f-79b8-451a-9384-19533b81d8c8	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	The Kroger Co.	d2095c7b-61ca-40d3-bbf1-04bed4dd789c	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DIMETHICONE	The Kroger Co.	ea8b186c-82d5-4552-bcce-03e56023ea99	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash Cream	ZINC OXIDE	Smalls Brand LLC DBA Roe Wellness	4bd29285-29b4-5d57-e063-6294a90af481	2026-02-27	Warnings	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Walmart Inc.	5893801a-25e1-4750-a55b-d9cddd3f1284	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Walmart Inc.	320bcbd3-9e91-437f-99c5-066f880a4b32	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Skin Protectant	PETROLATUM	Walmart Inc.	eb836922-f467-42ab-a6e7-b787d97e6c17	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Walmart Inc.	aa7dbf7f-50be-475b-8140-68be3fa93507	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Walmart Inc.	176d7711-7c4f-4319-91af-0aba1260c412	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Soothing Moisturizing	COLLOIDAL OATMEAL	Walmart Inc.	2d813455-c268-4c6d-9952-eaf0e0007d90	2026-02-27	Warnings, Adverse reactions	Exact identifier application number: M016
Rapid Repair Healing Cream	ALLANTOIN, DIMETHICONE	June Jacobs Labs LLC	186c13be-5e41-b9c9-e063-6294a90ad574	2026-02-26	Warnings	Exact identifier application number: M016
Lanashield	LANOLIN	Dynarex Corporation	94b277dc-6512-4d36-8485-8ea510097428	2026-02-26	Warnings	Exact identifier application number: M016
GLADSKIN ECZEMACT ECZEMA	COLLOIDAL OATMEAL	Micreos North America, Inc.	06f9af75-c5ff-d37b-e063-6394a90a4f6c	2026-02-25	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