THERA Calazinc Body Shield

Product NDC: 68599-0205
11-digit product format: 685990205
Labeler code: 68599
Product ID: 68599-0205_1b1bf6ec-a0cf-df7a-e063-6394a90af9f6
Type: HUMAN OTC DRUG
Nonproprietary name: Zinc Oxide
Dosage form: PASTE
Route: TOPICAL
Labeler: McKesson Medical-Surgical Inc.
Application: M016
Marketing category: OTC MONOGRAPH DRUG
Marketing start: 2011-09-01
Substance: ZINC OXIDE
Active strength: 200 mg/g
NDC exclude flag: No
Listing certified through: 2027-12-31
Current FDA listing: Yes

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

Additional Listing Data#

Finished product: Yes
Brand name base: THERA Calazinc Body Shield
Listing expiration: 2027-12-31

Active Ingredients#

Ingredient, Strength table
Ingredient	Strength
ZINC OXIDE	200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
SOI2LOH54Z	Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
Identifier	FDA.report destination
974b1046-83ee-4207-91d3-40982beb9c63	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f47a510b-6679-4664-b2d6-47b5c4afe7cc	Product name	4	20260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61c	Product name	2	20250515
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
0306390c-dd77-4363-afe0-63c58088b2a1	Product name	1	20220120
503ea967-4b9c-48cf-9e87-c7975295849d	Product name	2	20220120
5e18e798-5614-cf5c-0185-38b1cb77a093	Product name	2	20160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6a	Product name	1	20150324
fc363c46-397b-4476-ac0f-70e43e8e4592	Product name	1	20150324
1681bc73-b05f-12c3-1075-382ae39f449c	Product name	1	20140508
190f2a5b-bbc8-65c7-fcb0-97891307b917	Product name	1	20140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68599-0205-1	THERA Calazinc Body Shield	144 in 1 CARTON	PASTE	144	5
68599-0205-1	THERA Calazinc Body Shield	4 g in 1 PACKET	PASTE	4	5
68599-0205-4	THERA Calazinc Body Shield	113 g in 1 TUBE	PASTE	113	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
ZINC OXIDE	ACTIVE INGREDIENT	SOI2LOH54Z	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
ZINC OXIDE	ACTIVE MOIETY	SOI2LOH54Z	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
KUKUI NUT OIL	INACTIVE INGREDIENT	TP11QR7B8R	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-0205	THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240619_974b1046-83ee-4207-91d3-40982beb9c63.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 63 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Hydro Gel	GLYCERIN 20%	Trifecta Pharmaceuticals USA LLC	02e8e5d0-7844-39fe-e063-6394a90a57e1	2024-01-19	Warnings	Exact identifier application number: M016
White Petrolatum	WHITE PETROLATUM	Sled Distribution, LLC	e73a4b7a-7b27-abfc-e053-2995a90a35c2	2024-01-15	Warnings	Exact identifier application number: M016
Sunmark Caldiphen	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Strategic Sourcing Services	4f4d4c54-64b5-4e20-bed0-c7fb470b8434	2024-01-12	Warnings	Exact identifier application number: M016
EIGHT HOUR NIGHT	DIMETHICONE	REVLON	b3b277f9-565a-636c-e053-2995a90a94d2	2024-01-12	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Eczema Relief Creamy	OATMEAL	L'Oreal USA Products Inc	bcf7b985-6875-4033-a412-1bb6d3afa6d8	2024-01-01	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Healing	PETROLATUM	L'Oreal USA Products Inc.	1b3ad3e8-cbac-4a92-84e2-4f3ab4512d95	2023-12-31	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Baby Healing	PETROLATUM	L'Oreal USA Products Inc.	fe665bbc-1172-4f59-acc6-8d5c179693b6	2023-12-31	Warnings	Exact identifier application number: M016
Quality Choice Anti-Itch Clear	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Chain Drug Market Association	e3c0c46d-3d85-411d-a543-009064cdd19e	2023-12-28	Warnings	Exact identifier application number: M016
CeraVe Developed with Dermatologists Therapeutic Hand	DIMETHICONE	L'Oreal USA Products Inc	7fe49112-4180-415c-a380-768a8d6b2185	2023-12-28	Warnings	Exact identifier application number: M016
Calaclear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	Pharma Nobis, LLC	e42fccc2-1b4e-e7f3-e053-2a95a90aef39	2023-12-26	Warnings	Exact identifier application number: M016
Calamine Phenolated Topical Suspension	CALAMINE AND ZINC OXIDE AND PHENOL	Pharma Nobis, LLC	e42fbdcc-3291-7761-e053-2995a90a7172	2023-12-26	Warnings	Exact identifier application number: M016
Humco Calagesic	CALAMINE AND PRAMOXINE HYDROCHLORIDE	Pharma Nobis, LLC	e42fb807-8cb4-ed25-e053-2995a90a6780	2023-12-26	Warnings	Exact identifier application number: M016
Leader Calamine Plus	ZINC OXIDE LOTION	Cardinal Health, 110 dba Leader	81f29789-f794-1e64-e053-2a91aa0ac85e	2023-12-22	Warnings	Exact identifier application number: M016
CVS Calamine Plus	ZINC OXIDE	CVS Pharmacy	b90cd214-d44a-4458-876d-59cc0795226d	2023-12-22	Warnings	Exact identifier application number: M016
Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Pharma Nobis, LLC	e42f0bd6-3ad3-7e07-e053-2995a90a564a	2023-12-22	Warnings	Exact identifier application number: M016
DDM Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Discount Drug Mart	5d53685b-ca4c-35c1-e053-2a91aa0aff6e	2023-12-20	Warnings	Exact identifier application number: M016
DDM Calagesic	ZINC ACETATE AND PRAMOXINE HYDROCHLORIDE	Discount Drug Mart	5d537a11-049e-0a8d-e053-2a91aa0aa0c3	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Strategic Sourcing Services LLC	349ea07d-79bc-46f3-9d60-85b40db51bbb	2023-12-20	Warnings	Exact identifier application number: M016
Health Mart Witch Hazel	WITCH HAZEL	Strategic Sourcing Services LLC	2a1d9b27-0bd4-4475-8218-ba0f5560a969	2023-12-20	Warnings	Exact identifier application number: M016
Quality Choice Calamine	CALAMINE 8% AND ZINC OXIDE 8%	Chain Drug Market Association	62fe653f-e861-472b-b193-4fdd9d25de8d	2023-12-20	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
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
68599-0205-1	68599020501	144 PACKET in 1 CARTON (68599-0205-1) / 4 g in 1 PACKET	144 packet	2011-09-01	0000-00-00	No	No	Current
68599-0205-4	68599020504	113 g in 1 TUBE (68599-0205-4)	113 g	2011-09-01	0000-00-00	No	No	Current