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
Ingredient	Strength
DIMETHICONE	15 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
92RU3N3Y1O	Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
Identifier	FDA.report destination
309917	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
56869b64-11ee-4df6-8102-ce5818e0116e	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
59361619-24d9-b610-eca6-5a7f25ed5e03	Product name	5	20240909
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
68599-0204-1	THERA Moisturizing Body Shield	4 g in 1 PACKET	CREAM	4	5
68599-0204-1	THERA Moisturizing Body Shield	144 in 1 CARTON	CREAM	144	5
68599-0204-4	THERA Moisturizing Body Shield	113 g in 1 TUBE	CREAM	113	5

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
DIMETHICONE	ACTIVE INGREDIENT	92RU3N3Y1O	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
DIMETHICONE	ACTIVE MOIETY	92RU3N3Y1O	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
.ALPHA.-TOCOPHEROL ACETATE, DL-	INACTIVE INGREDIENT	WR1WPI7EW8	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
ALOE VERA LEAF	INACTIVE INGREDIENT	ZY81Z83H0X	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
CALCIUM PANTOTHENATE	INACTIVE INGREDIENT	568ET80C3D	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
CYCLOMETHICONE 5	INACTIVE INGREDIENT	0THT5PCI0R	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
DICAPRYLYL CARBONATE	INACTIVE INGREDIENT	609A3V1SUA	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
GINGER	INACTIVE INGREDIENT	C5529G5JPQ	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
HYALURONATE SODIUM	INACTIVE INGREDIENT	YSE9PPT4TH	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
KUKUI NUT	INACTIVE INGREDIENT	J87WJ3E7VW	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
LEVOMENOL	INACTIVE INGREDIENT	24WE03BX2T	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
NIACINAMIDE	INACTIVE INGREDIENT	25X51I8RD4	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PHENOXYETHANOL	INACTIVE INGREDIENT	HIE492ZZ3T	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PROPYLHEPTYL CAPRYLATE	INACTIVE INGREDIENT	991Z19V2OD	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
PYRIDOXINE HYDROCHLORIDE	INACTIVE INGREDIENT	68Y4CF58BV	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SAFFLOWER OIL	INACTIVE INGREDIENT	65UEH262IS	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SILICON DIOXIDE	INACTIVE INGREDIENT	ETJ7Z6XBU4	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SODIUM ASCORBYL PHOSPHATE	INACTIVE INGREDIENT	836SJG51DR	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
SODIUM CHLORIDE	INACTIVE INGREDIENT	451W47IQ8X	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
68599-0204	THERA MOISTURIZING BODY SHIELD (DIMETHICONE) CREAM [MCKESSON MEDICAL-SURGICAL INC.]	5	Current NDC, Legacy NDC, 3 package rows	20240619_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 59 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Vitamin A and D	VITAMIN A AND D	MIDWOOD BRANDS, LLC	1d0ebe9a-cbc5-1765-e063-6294a90aa476	2024-07-18	Warnings	Exact identifier application number: M016
Kidgets Baby Petroleum Jelly	BABY PETROLEUM JELLY	MIDWOOD BRANDS, LLC.	1d0eb8be-13b7-c466-e063-6294a90a93b9	2024-07-11	Warnings	Exact identifier application number: M016
Ivarest	ZINC OXIDE, BENZYL ALCOHOL, AND DIPHENHYDRAMINE HYDROCHLORIDE	Blistex Inc	6f68cbbb-6269-4bb3-8cc9-50b146703b42	2024-07-09	Warnings	Exact identifier application number: M016
Best Choice Diaper Rash	ZINC OXIDE	Trifecta Pharmaceuticals USA LLC	1be37841-e0a8-a0de-e063-6294a90a9eb1	2024-06-27	Warnings	Exact identifier application number: M016
Gas Relief Ultra Strength	SIMETHICONE	Walgreens	00a9164a-1817-4130-9c7f-9f5833c9690f	2024-06-26	Warnings	Exact identifier application number: M016
Astonea Skin Protectant	ZINC OXIDE	ASTONEA LABS PRIVATE LIMITED	e3c7a515-3e77-da85-e053-2995a90a3ee1	2024-06-25	Warnings	Exact identifier application number: M016
Astonea Vitamin A and D	WHITE PETROLATUM	ASTONEA LABS PRIVATE LIMITED	ef7c357b-5ff6-b9d7-e053-2a95a90a1dcf	2024-06-25	Warnings	Exact identifier application number: M016
ZOEY NATURALS DIAPER Cream	ZINC OXIDE	Absolutely Natural	70fac4d6-8833-4799-b6b6-796f8f13f80e	2024-06-25	Warnings	Exact identifier application number: M016
Medicated Body	MENTHOL AND ZINC OXIDE	Universal Distribution Center LLC	2a59a847-cc7a-42cf-b49a-92e7254c1629	2024-06-19	Warnings	Exact identifier application number: M016
THERA Moisturizing Body Shield	DIMETHICONE	McKesson Medical-Surgical Inc.	56869b64-11ee-4df6-8102-ce5818e0116e	2024-06-18	Warnings	Exact identifier application number: M016 ndc (product): 68599-0204
Dimethicone	SKIN PROTECTANT	McKesson	96886b33-44d4-5a2a-e053-2a95a90a505e	2024-06-18	Warnings	Exact identifier application number: M016
Derma E Eczema Relief	OATMEAL	derma e	767c4a76-8ccb-4530-9b4b-a7ea1a596c7f	2024-06-18	Warnings	Exact identifier application number: M016
Insect sting relief pad 01	SODIUM BICARBONATE	Cosmuses Cosmetics (Ningbo) Co., Ltd.	1b0f0088-6482-6de7-e063-6294a90aeeb7	2024-06-17	Warnings	Exact identifier application number: M016
THERA Calazinc Body Shield	ZINC OXIDE	McKesson Medical-Surgical Inc.	974b1046-83ee-4207-91d3-40982beb9c63	2024-06-17	Warnings	Exact identifier application number: M016
Dimethicone	BODY CLEANSER	McKesson	8ffe6ec3-8f5f-0c9b-e053-2995a90ac3a8	2024-06-14	Warnings	Exact identifier application number: M016
Dr. Mom Butt Balm	DIMETHICONE PETROLATUM	Ferndale Laboratories, Inc.	ec06f1fd-c3e1-5dfc-e053-2a95a90a7cdd	2024-06-13	Warnings	Exact identifier application number: M016
Secura Protective	PETROLATUM	Smith & Nephew Medical Ltd	20906566-fbf2-46d9-a5d8-c7f7356d1080	2024-06-12	Warnings	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	NuCare Pharmaceuticals,Inc.	66e98554-e158-a519-e053-2a91aa0a6783	2024-06-06	Warnings, Adverse reactions	Exact identifier application number: M016
CVS Health Vitamin A and D Skin Protectant	LANOLIN AND PETROLATUM	CVS Health	fe3ccabb-9644-4091-9dca-ffd96a43ecaf	2024-05-28	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	186a9642-cd73-adfb-e063-6394a90a75c7	2024-05-14	Warnings	Exact identifier application number: M016

UNII, Preferred term, Registry number table
UNII	Preferred term	Registry number	Matched term
92RU3N3Y1O	DIMETHICONE	9006-65-9	DIMETHICONE

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
309917	dimethicone 1.5 % Topical Cream	PSN	56869b64-11ee-4df6-8102-ce5818e0116e	5
309917	dimethicone 15 MG/ML Topical Cream	SCD	56869b64-11ee-4df6-8102-ce5818e0116e	5
309917	dimethicone 1.5 % Topical Cream	SY	56869b64-11ee-4df6-8102-ce5818e0116e	5

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Marketing start	Marketing end	Sample	Exclude flag	Status
68599-0204-1	68599020401	144 PACKET in 1 CARTON (68599-0204-1) / 4 g in 1 PACKET	144 packet	2011-09-01	0000-00-00	No	No	Current
68599-0204-4	68599020404	113 g in 1 TUBE (68599-0204-4)	113 g	2011-09-01	0000-00-00	No	No	Current