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
IngredientStrength
ZINC OXIDE200 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
SOI2LOH54ZInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
974b1046-83ee-4207-91d3-40982beb9c63Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f47a510b-6679-4664-b2d6-47b5c4afe7ccProduct name420260217
030ce964-9b2d-45aa-b5d3-f78ce03ef61cProduct name220250515
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
0306390c-dd77-4363-afe0-63c58088b2a1Product name120220120
503ea967-4b9c-48cf-9e87-c7975295849dProduct name220220120
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
190f2a5b-bbc8-65c7-fcb0-97891307b917Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0205-1THERA Calazinc Body Shield144 in 1 CARTONPASTE1445
68599-0205-1THERA Calazinc Body Shield4 g in 1 PACKETPASTE45
68599-0205-4THERA Calazinc Body Shield113 g in 1 TUBEPASTE1135

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54ZTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
ZINC OXIDEACTIVE MOIETYSOI2LOH54ZTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
KUKUI NUT OILINACTIVE INGREDIENTTP11QR7B8RTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9UTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRTHERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0205THERA CALAZINC BODY SHIELD (ZINC OXIDE) PASTE [MCKESSON MEDICAL-SURGICAL INC.]5Current NDC, Legacy NDC, 3 package rows20240619_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 39 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Novita Petrolatum Jelly PinkPETROLATUMShield Line LLC3e9d4992-5c1a-16d9-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Novita Pure Petrolatum JellyPETROLATUMShield Line LLC3c55614f-932d-4898-e054-00144ff88e882025-08-18WarningsExact identifier
application number: M016
Arthcal Bioidentical Peach CreamARTHCAL BIOIDENTICAL PEACH CREAMBeijing JUNGE Technology Co., Ltd.3c77f787-b7dd-6813-e063-6394a90aa0042025-08-16Boxed warning, WarningsExact identifier
application number: M016
Natureplex Diaper RashZINC OXIDENatureplex LLC41fe8db3-727c-4bbe-a5ea-62efee4b97b02025-08-15WarningsExact identifier
application number: M016
Aloe Vera Petrolatum JellyPETROLATUMShield Line LLCfdf3b90e-a434-49b2-e053-6394a90ab1752025-08-15WarningsExact identifier
application number: M016
AmeriDerm PeriShieldZINC OXIDEShield Line LLC417f1541-d65a-4612-b96b-e6183fbef1f32025-08-15WarningsExact identifier
application number: M016
AmeriDerm Vitamin A DWHITE PETROLATUMShield Line LLCb73a8fc9-fa00-774a-e053-2995a90afd1e2025-08-15WarningsExact identifier
application number: M016
Baby Petrolatum JellyPETROLATUMSHIELD LINE LLC35c163e6-ae41-2791-e054-00144ff8d46c2025-08-15WarningsExact identifier
application number: M016
MedPride EN SHIELD ALOE SOFT VITAMIN ENRICHEDZINC OXIDEShield Line LLC890ba245-ef37-4c62-ae82-980cb78acfb62025-08-15WarningsExact identifier
application number: M016
Earth Mama Eczema CreamCOLLOIDAL OATMEALEarth Mama Angel Baby, LLCbd30b525-f68c-4786-9fbc-745e2634c6bb2025-08-12WarningsExact identifier
application number: M016
Vitacilina Bebe Diaper RashZINC OXIDETaisho Pharmaceutical California Inc.6701e929-700e-40a4-9117-81e36577bfe12025-08-07WarningsExact identifier
application number: M016
Durma DynaGelDURMA DYNAGELDynarex Corporation3bcbe314-98ca-78f1-e063-6394a90a13ad2025-08-07WarningsExact identifier
application number: M016
Bath Bomb 2-pack (Lemon)ALLANTOINCarolina Cannabis Creations LLC08c7c313-cf36-fb46-e063-6294a90a73042025-08-06WarningsExact identifier
application number: M016
Earthmed Lip Balm Strawberry RhubarbALLANTOINEarthmed LLC3b54eea1-2e09-2ee1-e063-6294a90a52e52025-08-05WarningsExact identifier
application number: M016
ProCure Skin Repair CreamDIMETHICONE 1.5%Twin Med LLC3ba3d3b3-ab13-ea80-e063-6394a90ad4592025-08-05WarningsExact identifier
application number: M016
Earthmed FS Hand and footALLANTOINEarthmed LLC3ba592e9-2ef1-d20a-e063-6394a90a9bae2025-08-05WarningsExact identifier
application number: M016
Earthmed FS massage oilALLANTOINEarthmed LLC3ba64ad2-61b1-8021-e063-6294a90a73352025-08-05WarningsExact identifier
application number: M016
Petroleum JellyBABY PETROLEUM JELLYNeilMed Pharmaceuticals Inc.3b861e02-671a-c9e5-e063-6394a90a8d0f2025-08-04WarningsExact identifier
application number: M016
Earthmed Sport massage oilALLANTOINEarthmed LLC3b92e87d-ba8d-4bac-e063-6294a90a106e2025-08-04WarningsExact identifier
application number: M016
EA EIGHT HOUR SKIN PROTECTANTPETROLATUMREVLONb590991c-8ec8-67c2-e053-2a95a90a3acf2025-08-01WarningsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0205-168599020501144 PACKET in 1 CARTON (68599-0205-1) / 4 g in 1 PACKET144 packet2011-09-010000-00-00NoNoCurrent
68599-0205-468599020504113 g in 1 TUBE (68599-0205-4) 113 g2011-09-010000-00-00NoNoCurrent