REMEDY Calazime Skin Protectant

Product NDC: 53329-165
Requested package NDC: 53329-165-02
11-digit product format: 533290165
Labeler code: 53329
Product ID: 53329-165_2cdaa63c-2a2f-2fde-e063-6394a90a70c6
Type: HUMAN OTC DRUG
Nonproprietary name: calamine, menthol, white petrolatum, zinc oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: Medline Industries, LP
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2012-03-23
Substance: FERRIC OXIDE RED; MENTHOL; PETROLATUM; ZINC OXIDE
Active strength: .5; .2; 69; 19.5 g/100g; g/100g; g/100g; g/100g
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

Additional Listing Data#

Finished product: Yes
Brand name base: REMEDY Calazime Skin Protectant
Listing expiration: 2026-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
FERRIC OXIDE RED	.5 g/100g
MENTHOL	.2 g/100g
ZINC OXIDE	69 g/100g
PETROLATUM	19.5 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1K09F3G675	Internal UNII lookup
L7T10EIP3A	Internal UNII lookup
SOI2LOH54Z	Internal UNII lookup
4T6H12BN9U	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1921772	Internal RxNorm lookup

Harmonized SPL set identifiers#

SPL set identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
1295cfcc-5b61-481b-964b-f53ffd0cb58e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
7b19f89e-0a13-4d4e-a994-a46d39d008b9	Product name	1	20251120
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
13c3e0af-2da2-8aec-9e17-1afd680d80c2	Product name	8	20221116
c5cd4727-ac49-4409-82b1-5bd8006c3ec7	Product name	1	20171122
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
f46c867f-cde5-4f14-a7c1-18ae3a6efd1c	Product name	1	20160303
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
60c52429-fcef-eb54-2387-43bc9e4f296b	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDC	Effective	Related label
53329-165-02	2023-08-08	165 REMEDY Calazime Skin Protectant
53329-165-44	2023-08-08	165 REMEDY Calazime Skin Protectant
53329-165-96	2023-08-08	165 REMEDY Calazime Skin Protectant
53329-165-02	2023-07-28	165 REMEDY Calazime Skin Protectant
53329-165-44	2023-07-28	165 REMEDY Calazime Skin Protectant
53329-165-96	2023-07-28	165 REMEDY Calazime Skin Protectant

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
53329-165-02	REMEDY Calazime Skin Protectant	3 in 1 BAG	PASTE	3	9
53329-165-44	REMEDY Calazime Skin Protectant	113 g in 1 TUBE	PASTE	113	9
53329-165-96	REMEDY Calazime Skin Protectant	4 g in 1 PACKET	PASTE	4	9
53329-165-96	REMEDY Calazime Skin Protectant	144 in 1 BOX	PASTE	144	9

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-165-44	GM - Gram	53329-165	a485e81b-8b21-4e4e-83f9-8ba27da044a4	1	2013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
FERRIC OXIDE RED	ACTIVE INGREDIENT	1K09F3G675	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
MENTHOL	ACTIVE INGREDIENT	L7T10EIP3A	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
PETROLATUM	ACTIVE INGREDIENT	4T6H12BN9U	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
FERRIC OXIDE RED	ACTIVE MOIETY	1K09F3G675	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
MENTHOL	ACTIVE MOIETY	L7T10EIP3A	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
PETROLATUM	ACTIVE MOIETY	4T6H12BN9U	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
.ALPHA.-TOCOPHEROL	INACTIVE INGREDIENT	H4N855PNZ1	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ACETYLCYSTEINE	INACTIVE INGREDIENT	WYQ7N0BPYC	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ASCORBIC ACID	INACTIVE INGREDIENT	PQ6CK8PD0R	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ASCORBYL PALMITATE	INACTIVE INGREDIENT	QN83US2B0N	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
CHOLECALCIFEROL	INACTIVE INGREDIENT	1C6V77QF41	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
CITRUS MAXIMA FRUIT RIND OIL	INACTIVE INGREDIENT	8U3877WD44	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
CORN OIL	INACTIVE INGREDIENT	8470G57WFM	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
DIMETHYL SULFONE	INACTIVE INGREDIENT	9H4PO4Z4FT	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
GLYCINE	INACTIVE INGREDIENT	TE7660XO1C	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
HYDROXYTYROSOL	INACTIVE INGREDIENT	QEU0NE4O90	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE)	INACTIVE INGREDIENT	461P5CJN6T	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
OLIVE OIL	INACTIVE INGREDIENT	6UYK2W1W1E	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
ORANGE OIL	INACTIVE INGREDIENT	AKN3KSD11B	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
POLYETHYLENE GLYCOL 400	INACTIVE INGREDIENT	B697894SGQ	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
SUNFLOWER OIL	INACTIVE INGREDIENT	3W1JG795YI	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
VANILLIN	INACTIVE INGREDIENT	CHI530446X	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1
VITAMIN A PALMITATE	INACTIVE INGREDIENT	1D1K0N0VVC	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
53329-165	REMEDY CALAZIME SKIN PROTECTANT (CALAMINE, MENTHOL, WHITE PETROLATUM, ZINC OXIDE) PASTE [MEDLINE INDUSTRIES, LP]	9	Current NDC, Legacy NDC, 4 package rows	20250130_1295cfcc-5b61-481b-964b-f53ffd0cb58e.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 1 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Nail Fungus Repairing Liquid	GLYCERIN	Shantou Ximonth Biotechnology Co., Ltd.	57b8b3e5-88be-3a91-e063-6294a90a05be	2026-07-28	Warnings	Exact identifier application number: M016
DERMFREE INSECT BITE RELIEF	SODIUM BICARBONATE 5% INSECT BITE RELIEF	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	5794886c-0d74-9f35-e063-6394a90a27d8	2026-07-27	Warnings	Exact identifier application number: M016
OKeeffes Lip Repair SEAL and HEAL	PETROLATUM	The Gorilla Glue Company/O'Keeffe's Company	55f66f54-da39-76c7-e063-6394a90aeda9	2026-07-27	Warnings	Exact identifier application number: M016
Boo Boo Magic Diaper Rash Creamy	ZINC OXIDE	Alboo Brands LLC	5114aff8-adde-e610-e063-6294a90a77ea	2026-07-27	Warnings	Exact identifier application number: M016
PrevaDRM Vitamin Repair	SKIN PROTECTANT	Sion Brands LLC	579e4639-a742-1901-e063-6294a90a2d45	2026-07-27	Warnings	Exact identifier application number: M016
Hello Bello Diaper Rash Cream	ZINC OXIDE	Topiderm, Inc.	e158ba31-e159-4624-a490-fe70baaf4a39	2026-07-24	Warnings	Exact identifier application number: M016
Gethorey Vein Target Microneedle Patch	ALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57593145-a874-15d9-e063-6294a90a77d9	2026-07-24	Warnings	Exact identifier application number: M016
Fresh Scent PROTECTIVE BABY	ZINC OXIDE	CVS Pharmacy, Inc.	3f33c62c-43ec-4576-a24d-bd5de07e74d2	2026-07-23	Warnings	Exact identifier application number: M016
Estriol Cream	ESTRIOL	Guangxi Keyun E-commerce Co., Ltd.	4deadcb6-0d46-bdd7-e063-6294a90a26d7	2026-07-23	Warnings	Exact identifier application number: M016
DERMFREE Vein Target Microneedle Patch	ALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCH	Wenzhou Yuyuan Pharmaceutical Co., Ltd.	57449e29-ec46-9c30-e063-6394a90a7b4a	2026-07-23	Warnings	Exact identifier application number: M016
Baby Vitamin A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a125ea-6f9f-310c-e063-6394a90acef2	2026-07-22	Warnings	Exact identifier application number: M016
First Aid A and D	LANOLIN 15.5%, PETROLATUM 53.4%	Walgreen Company	25a319d0-d39a-5ff0-e063-6394a90a671d	2026-07-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE AND ZINC OXIDE	Marie's Original Formulas LLC	57110309-9a3d-025f-e063-6394a90a015a	2026-07-22	Warnings	Exact identifier application number: M016
Dermasporin	LANOLIN	Marie's Original Formulas LLC	562f40aa-eeec-2b7c-e063-6294a90ad68d	2026-07-22	Warnings	Exact identifier application number: M016
CAREALL Vitamin A and D	PETROLATUM	New World Imports, Inc	ef89a68a-74c1-4c42-8078-b7a208ace0de	2026-07-22	Warnings	Exact identifier application number: M016
Dermact	LANOLIN	Marie's Original Formulas LLC	57121dbe-e886-a562-e063-6294a90a367f	2026-07-22	Warnings	Exact identifier application number: M016
Universal WITCH HAZEL	WITCH HAZEL	Universal Distribution Center LLC	7e0b56ef-fa41-4862-b387-5b58d81d67d4	2026-07-22	Warnings	Exact identifier application number: M016
Aveeno Soothing Bath Treatment	OATMEAL	Kenvue Brands LLC	0c410b8e-025f-477c-afac-6e2e9ac88f7d	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE SCAR SHEETS	SILICONE GEL 1% SCAR SHEETS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a4ce316-4b92-7e81-e063-6294a90af6db	2026-07-21	Warnings	Exact identifier application number: M016
DERMFREE VARICOSE VEINS	DIMETHICONE 3% VARICOSE VEINS	Jiangxi Yudexi Pharmaceutical Co., LTD	4a5a2d1d-9e84-18eb-e063-6394a90a97ee	2026-07-21	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
1K09F3G675	FERRIC OXIDE RED	1309-37-1	FERRIC OXIDE RED
4T6H12BN9U	PETROLATUM	8009-03-8	PETROLATUM
SOI2LOH54Z	ZINC OXIDE	1314-13-2	ZINC OXIDE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1921772	calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste	PSN	1295cfcc-5b61-481b-964b-f53ffd0cb58e	9
1921772	calamine 0.035 MG/MG / menthol 0.002 MG/MG / petrolatum 0.69 MG/MG / zinc oxide 0.165 MG/MG Paste	SCD	1295cfcc-5b61-481b-964b-f53ffd0cb58e	9
1921772	Calamine 0.035 MG/MG / Menthol 0.002 MG/MG / Petrolatum 0.69 MG/MG / ZNO 0.165 MG/MG Paste	SY	1295cfcc-5b61-481b-964b-f53ffd0cb58e	9
1921772	calamine 3.5 % / menthol 0.2 % / petrolatum 69 % / zinc oxide 16.5 % Topical Paste	SY	1295cfcc-5b61-481b-964b-f53ffd0cb58e	9

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
53329-165-02	53329016502	3 TUBE in 1 BAG (53329-165-02) / 113 g in 1 TUBE (53329-165-44)	3 tube	2021-07-01	0000-00-00	No	No	Current