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 67 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
calahist	CALAMINE AND PRAMOXINE HYDROCHLORIDE	WALGREEN COMPANY	fed45e06-cc53-fbc5-e053-6294a90a1b19	2023-10-27	Warnings	Exact identifier application number: M016
calahist clear	PRAMOXINE HYDROCHLORIDE AND ZINC ACETATE	WALGREEN COMPANY	fed469c2-fe13-6726-e053-6394a90a5f51	2023-10-27	Warnings	Exact identifier application number: M016
Dr. Sayman Salve	SALVE	Sheffield Pharmaceuticals LLC	18bdcd0c-9c81-47e1-ae24-2239ff8fd066	2023-10-24	Warnings	Exact identifier application number: M016
Theriac Advanced Healing	LANOLIN	Sheffield Pharmaceuticals LLC	c780cd27-dc9e-45f3-97f0-e59b1b6b955a	2023-10-24	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Fragrance Free Diaper Rash	ZINC OXIDE	Babo Botanicals, Inc.	d66e369e-9b19-b084-e053-2995a90aa259	2023-10-23	Warnings	Exact identifier application number: M016
Babo Botanicals Sensitive Baby Healing	COLLOIDAL OATMEAL	Babo Botanicals, Inc.	08659a5c-2d10-2f98-e063-6394a90a7760	2023-10-23	Warnings	Exact identifier application number: M016
White Rose Petroleum Jelly	PETROLATUM	J. Strickland & Co.	1aeb090d-c103-4c2e-accc-d9d248315db9	2023-10-21	Warnings	Exact identifier application number: M016
Tricalm Hydrogel	ALUMINUM ACETATE	MODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES	082c6441-be47-4466-e063-6394a90ad500	2023-10-20	Warnings	Exact identifier application number: M016
Empower	WHITE PETROLATUM, ZINC OXIDE	Bemis Manufacturing Company Inc	08006b60-966b-155b-e063-6294a90a206a	2023-10-18	Warnings	Exact identifier application number: M016
ANUBISMED	HA HYALURONIC	ANUBIS COSMETICS SL	eac771e2-4c1b-3808-e053-2995a90ac5fc	2023-09-05	Warnings	Exact identifier application number: M016
AnubisMed	SODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREA	ANUBIS COSMETICS SL	ebf4b3ab-34e1-185a-e053-2a95a90ace3a	2023-09-05	Warnings	Exact identifier application number: M016
Anubis Barcelona	GLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICE	ANUBIS COSMETICS SL	eb651769-4d98-2b3b-e053-2a95a90a36b0	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE	ANUBIS COSMETICS SL	f22b212d-d21d-5984-e053-2995a90a683e	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	DMAE, ZIRHAFIRM	ANUBIS COSMETICS SL	f2274f8c-08aa-eb02-e053-2a95a90a3998	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Vital Line	HYDROLYZED ELASTIN, HYDROLYSED COLLAGEN, COCOGLYCERIDES	ANUBIS COSMETICS SL	ebe024f7-7c45-ad60-e053-2995a90a45d6	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOL	ANUBIS COSMETICS SL	ebdddcec-f5da-51fe-e053-2995a90a6167	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	PROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATE	ANUBIS COSMETICS SL	eb53cba1-0509-43bc-e053-2995a90a5e09	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Spa Line	ORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACID	ANUBIS COSMETICS SL	eb01a962-ab38-18ec-e053-2995a90acdeb	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona	FERULIC ACID, VITAMIN C, DMAE	ANUBIS COSMETICS SL	eaf0770c-795d-0232-e053-2a95a90ae0b5	2023-09-01	Warnings	Exact identifier application number: M016
Anubis Barcelona Total Hydrating	BETAINE, GLYCERIN, POLYSORBATE 20	ANUBIS COSMETICS SL	eaefe3b9-9064-18b1-e053-2a95a90a5765	2023-09-01	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