FDA.reportPublic FDA data

Dimethicone

Product NDC
68599-0213
11-digit product format
685990213
Labeler code
68599
Product ID
68599-0213_24c0a59c-1fad-f54e-e063-6394a90a5057
Type
HUMAN OTC DRUG
Nonproprietary name
Body Shield
Dosage form
CREAM
Route
TOPICAL
Labeler
McKesson
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2019-08-12
Substance
DIMETHICONE
Active strength
50 ug/mg
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
Dimethicone
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE50 ug/mg

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
8febb45d-a200-702c-e053-2995a90a3e62Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f2f8c312-f164-6104-0de4-ec45484840e3Product name220260304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
bbdc14c7-d940-43b5-a2f7-36c425991f3cProduct name120240320
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
6c13b22c-b3ba-4127-b768-0132dd5ab0d1Product name120230829
0c2e0212-b823-4ce8-611e-853ac2cac1b2Product name420230327
4d1338f1-f50a-5bb5-4946-11534fdee48fProduct name220210527
7fea2046-07a9-4bb6-9409-828ac6f1f6dfProduct name120210201
f059f1a2-0e64-4839-9a7f-42687c91a44bProduct name120201007
2e254488-9fcb-41b3-a7c3-e2c9a3941b29Product name120200603
b4ff0805-126a-406d-9cae-fc34fd8e8889Product name120190711
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
c148aeb5-688c-9b49-a40f-30a41e3595e4Product name220180419
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
bb6d6c68-649d-4e6d-a1f6-603d969c8f68Product name120160303
07737a91-49bd-c707-82e4-7a6a1660aef6Product name220150616
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
1681bc73-b05f-12c3-1075-382ae39f449cProduct name120140508
3db2f5c1-f78c-f062-515c-4827e36c2518Product name120140508
6f16fc1e-e77d-460f-8810-a12ca121425cProduct name120140508
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508
f74f326b-f453-01a0-e7e7-ce5ea9475503Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68599-0213-4Dimethicone118 mg in 1 BOTTLECREAM1184
68599-0213-4NuDermRxPAK 60118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2
68599-0213-4NuDermRxPAK 120118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2
68599-0213-4NuSurgePak Surgical Prep/CarePak118 mg in 1 BOTTLECREAM118 mg50 ug in 1mg2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68599-0213DIMETHICONE (BODY SHIELD) CREAM [MCKESSON]4Current NDC, Legacy NDC, 1 package rows20241020_8febb45d-a200-702c-e053-2995a90a3e62.zip
68599-0213NUDERMRXPAK 120 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210506_a838204b-9564-9aa6-e053-2a95a90af02f.zip
68599-0213NUDERMRXPAK 60 (CALCIPOTRIENE, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS,INC.]2Current NDC, Legacy NDC20210511_a837f13e-fafc-0535-e053-2995a90a5070.zip
68599-0213NUSURGEPAK SURGICAL PREP/CAREPAK (CHLORHEXIDINE GLUCONATE, MUPIROCIN, DIMETHICONE) KIT [NUCARE PHARMACEUTICALS INC]2Current NDC, Legacy NDC20200623_a83a55e8-58df-ac57-e053-2a95a90a9425.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 · 1,343 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Babo Botanicals Sensitive Baby HealingCOLLOIDAL OATMEALBabo Botanicals, Inc.08659a5c-2d10-2f98-e063-6394a90a77602023-10-23WarningsExact identifier
application number: M016
White Rose Petroleum JellyPETROLATUMJ. Strickland & Co.1aeb090d-c103-4c2e-accc-d9d248315db92023-10-21WarningsExact identifier
application number: M016
Tricalm HydrogelALUMINUM ACETATEMODULAR THERMAL TECHNOLOGIES LLC DBA LIFE WEAR TECHNOLOGIES082c6441-be47-4466-e063-6394a90ad5002023-10-20WarningsExact identifier
application number: M016
EmpowerWHITE PETROLATUM, ZINC OXIDEBemis Manufacturing Company Inc08006b60-966b-155b-e063-6294a90a206a2023-10-18WarningsExact identifier
application number: M016
ANUBISMEDHA HYALURONICANUBIS COSMETICS SLeac771e2-4c1b-3808-e053-2995a90ac5fc2023-09-05WarningsExact identifier
application number: M016
AnubisMedSODIUM BICARBONATE, ALOE BARBADENSIS LEAF JUICE, IMIDAZOLIDINYL UREAANUBIS COSMETICS SLebf4b3ab-34e1-185a-e053-2a95a90ace3a2023-09-05WarningsExact identifier
application number: M016
Anubis BarcelonaGLYCERIN, SORBITOL, ALOE BARBADENSIS LEAF JUICEANUBIS COSMETICS SLeb651769-4d98-2b3b-e053-2a95a90a36b02023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAEANUBIS COSMETICS SLf22b212d-d21d-5984-e053-2995a90a683e2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaDMAE, ZIRHAFIRMANUBIS COSMETICS SLf2274f8c-08aa-eb02-e053-2a95a90a39982023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROTEOGLYCAN, GLYCERIN, BUTYLENE GLYCOLANUBIS COSMETICS SLebdddcec-f5da-51fe-e053-2995a90a61672023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaPROPANEDIOL, GLYCERIN, MAGNESIUM ASCORBYL PHOSPHATEANUBIS COSMETICS SLeb53cba1-0509-43bc-e053-2995a90a5e092023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Spa LineORYZA SATIVA (RICE) STARCH, PERLITE, PALMITIC ACIDANUBIS COSMETICS SLeb01a962-ab38-18ec-e053-2995a90acdeb2023-09-01WarningsExact identifier
application number: M016
Anubis BarcelonaFERULIC ACID, VITAMIN C, DMAEANUBIS COSMETICS SLeaf0770c-795d-0232-e053-2a95a90ae0b52023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona Total HydratingBETAINE, GLYCERIN, POLYSORBATE 20ANUBIS COSMETICS SLeaefe3b9-9064-18b1-e053-2a95a90a57652023-09-01WarningsExact identifier
application number: M016
Anubis Barcelona New EvenLACTIC ACID, CITRIC ACID, GLYCOLIC ACIDANUBIS COSMETICS SLeaeeb6e0-5322-20c4-e053-2995a90a9fd92023-09-01WarningsExact identifier
application number: M016
Carmex Classic Lip Balm Medicated Free Cupcake Batter Stick Sunscreen SPF 15CAMPHOR (SYNTHETIC), PETROLATUMCarma Laboratories, Inc.5378d653-702d-405c-a067-882554aaf93a2023-08-21WarningsExact identifier
application number: M016
Quality Choice Anti-itch MedicatedCALAMINE AND PRAMOXINE HYDROCHLORIDECHAIN DRUG MARKETING ASSOCIATION INC5e07f26f-cfb6-57f9-e053-2991aa0a20082023-08-02WarningsExact identifier
application number: M016
Barrier BalmBARRIER BALMAutumn Harp, Inc.01df9746-991b-4363-e063-6294a90aaac62023-08-01WarningsExact identifier
application number: M016
Barrier CreamZINC OXIDEAvasol LLCbc6a2736-faa6-46d3-af9b-a70f0762e9ce2023-05-15WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Candy CaneCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Companybec2f702-5ff5-ea66-e053-2a95a90ad1ec2023-01-01WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
313921calcipotriene 0.005 % Topical CreamPSNa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamPSNa838204b-9564-9aa6-e053-2a95a90af02f2
211365chlorhexidine gluconate 4 % Medicated Liquid SoapPSNa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 2 % Topical OintmentPSNa83a55e8-58df-ac57-e053-2a95a90a94252
313921calcipotriene 0.05 MG/ML Topical CreamSCDa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.05 MG/ML Topical CreamSCDa838204b-9564-9aa6-e053-2a95a90af02f2
211365chlorhexidine gluconate 40 MG/ML Medicated Liquid SoapSCDa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 0.02 MG/MG Topical OintmentSCDa83a55e8-58df-ac57-e053-2a95a90a94252
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene (as calcipotriene monohydrate) 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
313921calcipotriene 0.005 % Topical CreamSYa837f13e-fafc-0535-e053-2995a90a50702
313921calcipotriene 0.005 % Topical CreamSYa838204b-9564-9aa6-e053-2a95a90af02f2
211365chlorhexidine gluconate 4 % Medicated Liquid SoapSYa83a55e8-58df-ac57-e053-2a95a90a94252
211365chlorhexidine gluconate 4 % Medicated Surgical ScrubSYa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 2 % Topical OintmentSYa83a55e8-58df-ac57-e053-2a95a90a94252
106346mupirocin 20 MG per GM Topical OintmentSYa83a55e8-58df-ac57-e053-2a95a90a94252

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68599-0213-468599021304118 mg in 1 BOTTLE (68599-0213-4) 118 mg2019-08-120000-00-00NoNoCurrent