THERA Moisturizing Body Shield

Product NDC
68599-0204
11-digit product format
685990204
Labeler code
68599
Product ID
68599-0204_1b291acd-e2c4-bcca-e063-6294a90a3a91
Type
HUMAN OTC DRUG
Nonproprietary name
Dimethicone
Dosage form
CREAM
Route
TOPICAL
Labeler
McKesson Medical-Surgical Inc.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-09-01
Substance
DIMETHICONE
Active strength
15 mg/g
Pharmacologic classes
Skin Barrier Activity [PE]
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 Moisturizing Body Shield
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
92RU3N3Y1OInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
309917Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
56869b64-11ee-4df6-8102-ce5818e0116eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0204-1THERA Moisturizing Body Shield4 g in 1 PACKETCREAM45
68599-0204-1THERA Moisturizing Body Shield144 in 1 CARTONCREAM1445
68599-0204-4THERA Moisturizing Body Shield113 g in 1 TUBECREAM1135

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
DIMETHICONEACTIVE INGREDIENT92RU3N3Y1OTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
DIMETHICONEACTIVE MOIETY92RU3N3Y1OTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
.ALPHA.-TOCOPHEROL ACETATE, DL-INACTIVE INGREDIENTWR1WPI7EW8THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0XTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
CALCIUM PANTOTHENATEINACTIVE INGREDIENT568ET80C3DTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
CYCLOMETHICONE 5INACTIVE INGREDIENT0THT5PCI0RTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
DICAPRYLYL CARBONATEINACTIVE INGREDIENT609A3V1SUATHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
GINGERINACTIVE INGREDIENTC5529G5JPQTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4THTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
KUKUI NUTINACTIVE INGREDIENTJ87WJ3E7VWTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
LEVOMENOLINACTIVE INGREDIENT24WE03BX2TTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
MALTODEXTRININACTIVE INGREDIENT7CVR7L4A2DTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
NIACINAMIDEINACTIVE INGREDIENT25X51I8RD4THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PHENOXYETHANOLINACTIVE INGREDIENTHIE492ZZ3TTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V3THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PROPYLHEPTYL CAPRYLATEINACTIVE INGREDIENT991Z19V2ODTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
PYRIDOXINE HYDROCHLORIDEINACTIVE INGREDIENT68Y4CF58BVTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SAFFLOWER OILINACTIVE INGREDIENT65UEH262ISTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU4THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM ASCORBYL PHOSPHATEINACTIVE INGREDIENT836SJG51DRTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
SODIUM CHLORIDEINACTIVE INGREDIENT451W47IQ8XTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1
WATERINACTIVE INGREDIENT059QF0KO0RTHERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0204THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]5Current NDC, Legacy NDC, 3 package rows20240619_56869b64-11ee-4df6-8102-ce5818e0116e.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 52 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Orajel Cold Sore MoisturelockBENZOCAINEChurch & Dwight Co., Inc.3761c7b3-053b-0f50-e054-00144ff88e882024-11-26WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCed08b690-f907-6d2f-e053-2a95a90af51c2024-11-25WarningsExact identifier
application number: M016
Johnsons First Touch Baby Gift SetZINC OXIDEKenvue Brands LLCda5469ea-3330-4f04-e053-2a95a90aff412024-11-25WarningsExact identifier
application number: M016
Lil Drug Store Petroleum JellyPETROLATUMLil Drug Store Products, Inca8a56786-20c3-43c1-a4db-8502ff08e4cb2024-11-25WarningsExact identifier
application number: M016
TerrasilMed ONCALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutionsf0cc9448-c531-4dd1-8f5c-5310e4abe1a92024-11-25WarningsExact identifier
application number: M016
TN Dickinsons Witch Hazel AstringentWITCH HAZELDickinson Brands Inc.a9596cf1-8204-447d-90f6-622bf497a7e02024-11-25WarningsExact identifier
application number: M016
PINXAV DAIPER RASHZINC OXIDEEmjay Laboratories Inc.14daf592-8edf-4679-9abf-de1b9d0799ff2024-11-21WarningsExact identifier
application number: M016
Target Maximum Strength Zinc Oxide Diaper RashZINC OXIDE DIAPER RASHTarget Corporation6ba2761c-4c05-498b-a012-e95843c205732024-11-21WarningsExact identifier
application number: M016
Target Baby HealingPETROLATUMTarget Corporation5a445a96-1652-47e0-b9bb-6e63fc1841082024-11-21WarningsExact identifier
application number: M016
Target Vitamin A and D Diaper RashVITAMIN A AND D OINTMENTTarget Corporation6a98e4b9-2906-4207-83ac-48f41fba190e2024-11-21WarningsExact identifier
application number: M016
Walgreens Baby HealingPETROLATUMWalgreens Company54100d5a-7ae1-45ec-94c4-e165b55a6c492024-11-20WarningsExact identifier
application number: M016
Baby Petroleum JellyWHITE PETROLATUM JELLYWALGREENS2008da4f-3c3c-4311-e063-6394a90a81e72024-11-20WarningsExact identifier
application number: M016
Vitamins A and D Without LanolinSKIN PROTECTANTDynarex Corporation822db5f4-d662-0689-e053-2a91aa0ace7e2024-11-20WarningsExact identifier
application number: M016
Vitamin A DPETROLATUMDynarex Corporation62ad33f6-46e6-435f-9a5f-e116c3e218bf2024-11-20WarningsExact identifier
application number: M016
Desitin Maximum Strength Diaper RashZINC OXIDEKenvue Brands LLCaf64fc2f-c027-4a68-b368-ee06744a24522024-11-15WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC1d5f0207-26f9-2b19-e063-6294a90a64682024-11-14WarningsExact identifier
application number: M016
Desitin Maximum Strength Zinc Oxide Diaper RashZINC OXIDEKenvue Brands LLC59728810-4ea9-45a1-b945-5a54199e01f32024-11-14WarningsExact identifier
application number: M016
Johnsons Baby Care Essentials Gift SetZINC OXIDEKenvue Brands LLCafa1ba48-b504-4af0-a9c7-cd2c9a2e6e592024-11-13WarningsExact identifier
application number: M016
70% ISOPROPYL RUBBING ALCOHOLISOPROPYL ALCOHOLMY IMPORTS USA LLC26cbc1af-a38f-146b-e063-6394a90a716c2024-11-13WarningsExact identifier
application number: M016
VITAMIN A and DVITAMIN A AND DALLIED TRADE LINK LLC26d426c3-4dfb-c984-e063-6394a90a37932024-11-13WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
309917dimethicone 1.5 % Topical CreamPSN56869b64-11ee-4df6-8102-ce5818e0116e5
309917dimethicone 15 MG/ML Topical CreamSCD56869b64-11ee-4df6-8102-ce5818e0116e5
309917dimethicone 1.5 % Topical CreamSY56869b64-11ee-4df6-8102-ce5818e0116e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0204-168599020401144 PACKET in 1 CARTON (68599-0204-1) / 4 g in 1 PACKET144 packet2011-09-010000-00-00NoNoCurrent
68599-0204-468599020404113 g in 1 TUBE (68599-0204-4) 113 g2011-09-010000-00-00NoNoCurrent