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 59 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Meijer Baby Petroleum Jelly Skin Protectant Frag Free	PETROLATUM	Meijer Distribution	0a0e6de8-b7c1-af7e-e063-6394a90a3ee2	2024-08-26	Warnings	Exact identifier application number: M016
Meijer Baby Petroleum Jelly Skin Protectant Fresh Scent	PETROLATUM	Meijer Distribution	0a0e9b39-9ce1-e788-e063-6294a90abf0b	2024-08-26	Warnings	Exact identifier application number: M016
Insect sting relief latex 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b9e2d4c-bc0c-6ed0-e063-6294a90a9103	2024-08-19	Warnings	Exact identifier application number: M016
Dove	CARE AND PROTECT ANTIBACTERIAL HAND WASH	Conopco Inc. d/b/a/ Unilever	b9f65122-4037-de0b-e053-2995a90ae510	2024-08-16	Warnings	Exact identifier application number: M016
BioBarrier Repair Eye Cream	ALLANTOIN	Bluemercury Inc.	1ee70a3c-76cc-335f-e063-6294a90a4f49	2024-08-04	Warnings	Exact identifier application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHED	ZINC OXIDE	Dabur India Ltd	1e6143c1-cd08-c171-e063-6394a90a2cee	2024-07-29	Warnings	Exact identifier application number: M016
HealthWise Petroleum Jelly	WHITE PETROLATUM	Veridian Healthcare	1e189d97-2677-e8d7-e063-6394a90ac3d6	2024-07-25	Warnings	Exact identifier application number: M016
Vitamin A and D	VITAMIN A AND D	MIDWOOD BRANDS, LLC	1d0ebe9a-cbc5-1765-e063-6294a90aa476	2024-07-18	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly	BABY PETROLEUM JELLY	MIDWOOD BRANDS, LLC.	1d0eb8be-13b7-c466-e063-6294a90a93b9	2024-07-11	Warnings	Exact identifier application number: M016
Ivarest	ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE	Blistex Inc	6f68cbbb-6269-4bb3-8cc9-50b146703b42	2024-07-09	Warnings	Exact identifier application number: M016
Best Choice Diaper Rash	ZINC OXIDE	Trifecta Pharmaceuticals USA LLC	1be37841-e0a8-a0de-e063-6294a90a9eb1	2024-06-27	Warnings	Exact identifier application number: M016
Gas Relief Ultra Strength	SIMETHICONE	Walgreens	00a9164a-1817-4130-9c7f-9f5833c9690f	2024-06-26	Warnings	Exact identifier application number: M016
Astonea Skin Protectant	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	e3c7a515-3e77-da85-e053-2995a90a3ee1	2024-06-25	Warnings	Exact identifier application number: M016
Astonea Vitamin A and D	WHITE PETROLATUM	ASTONEA LABS PRIVATE LIMITED	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2024-06-25	Warnings	Exact identifier application number: M016
ZOEY NATURALS DIAPER Cream	ZINC OXIDE	Absolutely Natural	70fac4d6-8833-4799-b6b6-796f8f13f80e	2024-06-25	Warnings	Exact identifier application number: M016
Medicated Body	MENTHOL AND ZINC OXIDE	Universal Distribution Center LLC	2a59a847-cc7a-42cf-b49a-92e7254c1629	2024-06-19	Warnings	Exact identifier application number: M016
THERA Moisturizing Body Shield	DIMETHICONE	McKesson Medical-Surgical Inc.	56869b64-11ee-4df6-8102-ce5818e0116e	2024-06-18	Warnings	Exact identifier application number: M016
Dimethicone	SKIN PROTECTANT	McKesson	96886b33-44d4-5a2a-e053-2a95a90a505e	2024-06-18	Warnings	Exact identifier application number: M016
Derma E Eczema Relief	OATMEAL	derma e	767c4a76-8ccb-4530-9b4b-a7ea1a596c7f	2024-06-18	Warnings	Exact identifier application number: M016
Insect sting relief pad 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b0f0088-6482-6de7-e063-6294a90aeeb7	2024-06-17	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