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 12 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Herpecin Pain ReliefALLANTOIN, BENZETHONIUM CHLORIDE, LIDOCAINE HCLFocus Consumer Healthcare, LLCbeeb6043-6547-4fe9-e053-2995a90a5d742026-04-30WarningsExact identifier
application number: M016
CVSPETROLATUMApollo Health and Beauty Care47d2b9be-91ad-e9e2-e063-6294a90ac29f2026-04-30WarningsExact identifier
application number: M016
Dr. NumbLIDOCAINEShinpharma Inc0578fbcb-875a-4606-acde-dcecb29756e62026-04-30WarningsExact identifier
application number: M016
Colloidal oatmealCOLLOIDAL OATMEALAmazon.com Services LLC423c821d-92af-47f0-b9ee-8b68ecbcc44e2026-04-29Warnings, Adverse reactionsExact identifier
application number: M016
MICRO INFUSIONSYSTEMSEEK GLONingbo Kenwei International Trade Co., Ltd.50746cab-bfcc-fe0b-e063-6394a90adc012026-04-27WarningsExact identifier
application number: M016
Pharmacy ChoiceMENTHOL, ZINC OXIDEPHARMACY CHOICE INC5031fc05-e1c7-40b1-e063-6394a90aa12c2026-04-24WarningsExact identifier
application number: M016
Sel pH baby PH-BALANCED ECZEMA DRYNESS BABYLOTIONSEL PH BABY PH-BALANCED ECZEMA DRYNESS BABYGuangzhou Ariel Biotech Co., Ltd.5040b707-87af-3859-e063-6294a90afb3d2026-04-24WarningsExact identifier
application number: M016
Caldesene BabySTARCH, CORN AND ZINC OXIDEInsight Pharmaceuticals LLC9f12dee2-7afa-45e9-a729-0fd42bb777152026-04-22WarningsExact identifier
application number: M016
Caldesene Medicated ProtectingCORNSTARCH AND ZINC OXIDEInsight Pharmaceuticals LLCffc92a0f-a7cf-4a46-b2f1-089df2bbb96b2026-04-22WarningsExact identifier
application number: M016
Arm and Hammer Baking SodaSODIUM BICARBONATEChurch & Dwight Co., Inc.643fe204-4a7b-00e4-e053-2a91aa0aef062026-04-21WarningsExact identifier
application number: M016
PURE PETROLATUMPETROLATUMMY IMPORTS USA LLC4fba8bc7-590d-f621-e063-6294a90ad8c92026-04-18WarningsExact identifier
application number: M016
Anti-Itch Regular StrengthHYDROCORTISONECVS Pharmacy9fe7768b-9023-c9ee-e053-2a95a90a55b32026-04-17WarningsExact identifier
application number: M016
Calamine ClearPRAMOXINE HYDROCHLORIDE AND ZINC ACETATE LOTIONPharma Nobis, LLC4f853183-5925-2c73-e063-6394a90adf6c2026-04-15WarningsExact identifier
application number: M016
Freskaro Calamine PlusZINC OXIDE LOTIONPharma Nobis, LLC4f85bdc7-8fed-f1f5-e063-6394a90a63582026-04-15WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDE OINTMENTDynarex Corporation11d79dd6-35f7-4399-e063-6294a90ac7dd2026-04-13WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f261746-37e9-7b30-e063-6294a90a92242026-04-10WarningsExact identifier
application number: M016
FB HYDRATING HAND SANITIZERFB HYDRATING HAND SANITIZERFAMILY DOLLAR SERVICES, LLC4f268501-6cd7-7edd-e063-6294a90ac6492026-04-10WarningsExact identifier
application number: M016
BEVERLY HILLS MD HYDRARESCUE TREATMENTDIMETHICONEBeverly Hills MD, LLC4ed33a43-d059-2589-e063-6294a90a30b32026-04-09WarningsExact identifier
application number: M016
Petroleum JellyWHITE PETROLATUMWAL-MART STORES INC00faa772-53f3-9276-e063-6394a90a2dab2026-04-07WarningsExact identifier
application number: M016
ProCure Zinc OxideZINC OXIDETwin Med LLC37a30ee5-fd33-b410-e063-6294a90aef722026-04-07WarningsExact 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