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 56 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Aveeno Daily Moisturizing	DIMETHICONE	Kenvue Brands LLC	70593b0c-c41b-4294-9bfa-42003ba1e3e4	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	029fbae2-06ad-4fe9-b542-834686c5cb97	2024-11-05	Warnings	Exact identifier application number: M016
Aveeno Skin Relief Overnight	DIMETHICONE	Kenvue Brands LLC	e7da6c9c-d6b0-4dc5-bfa4-68345f9c2d3c	2024-11-05	Warnings	Exact identifier application number: M016
Quality Choice Diaper Rash	ZINC OXIDE	Chain Drug Marketing Association Inc.	262e7eac-4b44-f224-e063-6394a90a4f59	2024-11-05	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Chain Drug Marketing Association Inc.	262f8cab-c7b8-b07e-e063-6294a90a1289	2024-11-05	Warnings	Exact identifier application number: M016
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	926706b5-0a08-4604-b5ad-3b3ddfd7f02d	2024-11-05	Warnings	Exact identifier application number: M016
Walgreens Eczema Relief Body Skin Protectant	OATMEAL	Walgreen Company	b2eebc2f-addd-4822-b224-04bd5f450653	2024-11-05	Warnings	Exact identifier application number: M016
ECZEMA	OATMEAL	ORGANIC & SUSTAINABLE BEAUTY	81eb3df4-5beb-45aa-82ca-e8b4b37e45f4	2024-11-05	Warnings, Adverse reactions	Exact identifier application number: M016
Aveeno Baby Calming Comfort	DIMETHICONE	Kenvue Brands LLC	567b1481-b783-45f9-af38-5630c9edf044	2024-11-01	Warnings	Exact identifier application number: M016
ZO Skin Health Astringent Solution	ALUMINUM ACETATE	ZO Skin Health, Inc.	cb801d7e-52ad-6c16-e053-2a95a90a7a1f	2024-10-31	Warnings	Exact identifier application number: M016
ZINC OXIDE PHARMA	ZINC OXIDE	ALLIED TRADE LINK LLC	1b580bf6-f217-5c0f-e063-6294a90a012e	2024-10-29	Warnings	Exact identifier application number: M016
Dove DermaSeries Eczema Relief Soothing Body	COLLOIDAL OATMEAL	Conopco, Inc. d/b/a/ Unilever	59f737f6-dd3f-4b63-b13e-2345cb9a951a	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER SHEA BUTTER	Conopco Inc. d/b/a/ Unilever	a735d885-bacd-0f5c-e053-2a95a90ad14a	2024-10-24	Warnings	Exact identifier application number: M016
Baby Dove	8H MOISTURIZATION HAND SANITIZER	Conopco Inc. d/b/a/ Unilever	b8dc481c-1ac3-2d63-e053-2a95a90a44f5	2024-10-24	Warnings	Exact identifier application number: M016
Vaseline	CLINICAL CARE HAND SANITIZER LOTION	Conopco Inc. d/b/a/ Unilever	ba0aa323-8887-597f-e053-2995a90a2077	2024-10-24	Warnings	Exact identifier application number: M016
Dove	NOURISHING HAND SANITIZER SENSITIVE SKIN 8HR MOISTURIZATION	Conopco Inc. d/b/a/ Unilever	d1039316-3ca8-90f8-e053-2995a90a2061	2024-10-24	Warnings	Exact identifier application number: M016
Dove	HAND SANITIZER LAVENDER	Conopco Inc. d/b/a/ Unilever	a736838b-b559-f066-e053-2995a90a90f5	2024-10-24	Warnings	Exact identifier application number: M016
Diaper Rash Cream 2.5oz	ZINC OXIDE	Rejoice International Corp.	130d94d8-ad98-d61f-e063-6294a90a76b0	2024-10-21	Warnings	Exact identifier application number: M016
HARMON DAILY MOISTURZIER	DIMETHICONE	HARMON STORES, INC.	bda5dbaa-5d62-4a40-ba55-e2066e8ca1c7	2024-10-21	Warnings	Exact identifier application number: M016
Dimethicone	BODY SHIELD	McKesson	8febb45d-a200-702c-e053-2995a90a3e62	2024-10-18	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