FDA.reportPublic FDA data

Monistat Complete Care Chafing Relief

Product NDC
63736-031
11-digit product format
637360031
Labeler code
63736
Product ID
63736-031_7298c9c8-609a-4f1e-967b-faf2d183aa77
Type
HUMAN OTC DRUG
Nonproprietary name
dimethicone
Dosage form
GEL
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-15
Substance
DIMETHICONE
Active strength
1.2 g/100g
Pharmacologic classes
Skin Barrier Activity [PE]
NDC exclude flag
No
Listing certified through
2026-12-31
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
Monistat Complete Care Chafing Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
DIMETHICONE1.2 g/100g

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
706952Internal RxNorm lookup
1117398Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
07d7c883-1fa3-4786-905c-a1fab649765eAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-031-01Monistat Complete Care Chafing Relief42 g in 1 TUBEGEL425
63736-031-01Monistat Complete Care Chafing Relief1 in 1 CARTONGEL15

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
dimethiconeACTIVE INGREDIENT92RU3N3Y1OMONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1
dimethiconeACTIVE MOIETY92RU3N3Y1OMONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1
.alpha.-tocopherol acetateINACTIVE INGREDIENT9E8X80D2L0MONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1
cyclomethicone 5INACTIVE INGREDIENT0THT5PCI0RMONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1
dimethicone/vinyl dimethicone crosspolymer (hard particle)INACTIVE INGREDIENTH895X08VNQMONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1
silicon dioxideINACTIVE INGREDIENTETJ7Z6XBU4MONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1
trisiloxaneINACTIVE INGREDIENT9G1ZW13R0GMONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-031MONISTAT COMPLETE CARE CHAFING RELIEF (DIMETHICONE) GEL [INSIGHT PHARMACEUTICALS LLC]5Current NDC, Legacy NDC, 2 package rows20240418_07d7c883-1fa3-4786-905c-a1fab649765e.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 41 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
terrasil Infection Protection Wound CareALLANTOINAidance Scientific, Inc, DBA Aidance Skincare & Topical Solutionse98d1d8c-c979-49de-9bd8-cd409efff6de2025-07-11WarningsExact identifier
application number: M016
Neosporin Lip Health Overnight Renewal TherapyPETROLATUMKenvue Brands LLC0da54fe1-c99f-4a2d-9ee5-2dc24005096c2025-07-10WarningsExact identifier
application number: M016
COCOA BUTTER PETROLEUM jellyPETROLATUMSavvy Care & Cosmetics Pvt. Ltd.397d13f1-3b86-3c76-e063-6394a90a0f242025-07-09WarningsExact identifier
application number: M016
Pipette EczemaCOLLOIDAL OATMEALPipette LLC39829827-d801-f5a7-e063-6394a90a024c2025-07-09WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEWestminster Pharmaceuticals, LLC7e045b3a-f33b-4faa-ab9b-2baec6ff79242025-07-08WarningsExact identifier
application number: M016
Desitin Multi-Purpose HealingPETROLATUMKenvue Brands LLC30f06dbb-de8c-43ee-b1ed-99ffd59dd3ab2025-07-07WarningsExact identifier
application number: M016
Astringent SolutionALUMINUM SULFATE TETRADECAHYDRATE, CALCIUM ACETATE MONOHYDRATEFirst Nation Group065c895c-7d86-f1ed-e063-6394a90a3a522025-07-07WarningsExact identifier
application number: M016
Creamy PetroleumPETROLATUMSavvy Care & Cosmetics Pvt Ltd3916daee-f8d2-e3f0-e063-6294a90a38832025-07-04WarningsExact identifier
application number: M016
Exemax CreamDIMETHICONE, ALLANTOINPureTek Corporation38e79055-df84-d314-e063-6394a90ac95f2025-07-01WarningsExact identifier
application number: M016
Procure Dimethicone 5%DIMETHICONETwin Med LLC38a7e4af-997d-549e-e063-6394a90a0bd62025-06-28WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDerma Sciences Canada Inc.37eff762-1ea9-ec66-e063-6394a90a3d102025-06-19WarningsExact identifier
application number: M016
Dr.Johnes SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLCb731c55e-31ee-429f-8432-fac7c5718d832025-06-18WarningsExact identifier
application number: M016
Dr. Johne SKIN TAG REMOVERSALICYLIC ACIDDr.Johnes LLC6c5adc3c-9d45-449a-ad42-f9571851cd182025-06-18WarningsExact identifier
application number: M016
THERAPLEX Eczema Therapy Moisturizing Skin Protectant with Colloidal OatmealOATMEALTHERAPLEX, LLCe51aa467-ffe7-4c6b-8588-6df8592596d42025-06-16WarningsExact identifier
application number: M016
ZIIDII Wild Yam CreamWILD YAMGuangzhou Haishi Biological Technology Co., Ltd.3733154a-4884-9988-e063-6294a90aa78c2025-06-10WarningsExact identifier
application number: M016
Aveeno Calm Plus Restore Skin Therapy BalmCOLLOIDAL OATMEALKenvue Brands LLCdbe7a2cc-9c21-2a48-e053-2a95a90a54e22025-06-04WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWALGREENS2017113f-d192-5fbb-e063-6294a90a83b02025-05-31WarningsExact identifier
application number: M016
AHHH Bite ReliefSODIUM BICARBONATE7827125a1e070-9228-4ec9-e063-6294a90ad78d2025-05-27WarningsExact identifier
application number: M016
SupreH Bee Venom Skin Tag Treatment LiquidSUPREH BEE VENOM SKIN TAG REMOVER LIQUIDShenzhen Xinxin Yunhai Technology Co., Ltd.35ca9836-917a-b0ac-e063-6294a90a28a22025-05-23WarningsExact identifier
application number: M016
terrasil Diabetics Ulcer and Bed Sore ReliefALLANTOINAidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions35d2738c-dacf-7309-e063-6294a90aab4c2025-05-23WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
706952dimethicone 1.2 % Topical GelPSN07d7c883-1fa3-4786-905c-a1fab649765e5
1117398MONISTAT COMPLETE CARE Chafing Relief 1.2 % Topical GelPSN07d7c883-1fa3-4786-905c-a1fab649765e5
1117398dimethicone 0.012 MG/MG Topical Gel [Monistat Soothing Care]SBD07d7c883-1fa3-4786-905c-a1fab649765e5
706952dimethicone 0.012 MG/MG Topical GelSCD07d7c883-1fa3-4786-905c-a1fab649765e5
706952dimethicone 1.2 % Topical GelSY07d7c883-1fa3-4786-905c-a1fab649765e5
1117398Monistat Soothing Care 0.012 MG/MG Topical GelSY07d7c883-1fa3-4786-905c-a1fab649765e5
1117398Monistat Soothing Care Chafing Relief 1.2 % Topical GelSY07d7c883-1fa3-4786-905c-a1fab649765e5

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-031-01637360031011 TUBE in 1 CARTON (63736-031-01) / 42 g in 1 TUBE1 tube2013-11-150000-00-00NoNoCurrent