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

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 1 of 69 · 1,363 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Nail Fungus Repairing LiquidGLYCERINShantou Ximonth Biotechnology Co., Ltd.57b8b3e5-88be-3a91-e063-6294a90a05be2026-07-28WarningsExact identifier
application number: M016
DERMFREE INSECT BITE RELIEFSODIUM BICARBONATE 5% INSECT BITE RELIEFWenzhou Yuyuan Pharmaceutical Co., Ltd.5794886c-0d74-9f35-e063-6394a90a27d82026-07-27WarningsExact identifier
application number: M016
OKeeffes Lip Repair SEAL and HEALPETROLATUMThe Gorilla Glue Company/O'Keeffe's Company55f66f54-da39-76c7-e063-6394a90aeda92026-07-27WarningsExact identifier
application number: M016
Boo Boo Magic Diaper Rash CreamyZINC OXIDEAlboo Brands LLC5114aff8-adde-e610-e063-6294a90a77ea2026-07-27WarningsExact identifier
application number: M016
PrevaDRM Vitamin RepairSKIN PROTECTANTSion Brands LLC579e4639-a742-1901-e063-6294a90a2d452026-07-27WarningsExact identifier
application number: M016
Hello Bello Diaper Rash CreamZINC OXIDETopiderm, Inc.e158ba31-e159-4624-a490-fe70baaf4a392026-07-24WarningsExact identifier
application number: M016
Gethorey Vein Target Microneedle PatchALLANTOIN 2% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57593145-a874-15d9-e063-6294a90a77d92026-07-24WarningsExact identifier
application number: M016
Fresh Scent PROTECTIVE BABYZINC OXIDECVS Pharmacy, Inc.3f33c62c-43ec-4576-a24d-bd5de07e74d22026-07-23WarningsExact identifier
application number: M016
Estriol CreamESTRIOLGuangxi Keyun E-commerce Co., Ltd.4deadcb6-0d46-bdd7-e063-6294a90a26d72026-07-23WarningsExact identifier
application number: M016
DERMFREE Vein Target Microneedle PatchALLANTOIN 1% VEIN TARGET MICRONEEDLE PATCHWenzhou Yuyuan Pharmaceutical Co., Ltd.57449e29-ec46-9c30-e063-6394a90a7b4a2026-07-23WarningsExact identifier
application number: M016
Baby Vitamin A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a125ea-6f9f-310c-e063-6394a90acef22026-07-22WarningsExact identifier
application number: M016
First Aid A and DLANOLIN 15.5%, PETROLATUM 53.4%Walgreen Company25a319d0-d39a-5ff0-e063-6394a90a671d2026-07-22WarningsExact identifier
application number: M016
CalamineCALAMINE AND ZINC OXIDEMarie's Original Formulas LLC57110309-9a3d-025f-e063-6394a90a015a2026-07-22WarningsExact identifier
application number: M016
DermasporinLANOLINMarie's Original Formulas LLC562f40aa-eeec-2b7c-e063-6294a90ad68d2026-07-22WarningsExact identifier
application number: M016
CAREALL Vitamin A and DPETROLATUMNew World Imports, Incef89a68a-74c1-4c42-8078-b7a208ace0de2026-07-22WarningsExact identifier
application number: M016
DermactLANOLINMarie's Original Formulas LLC57121dbe-e886-a562-e063-6294a90a367f2026-07-22WarningsExact identifier
application number: M016
Universal WITCH HAZELWITCH HAZELUniversal Distribution Center LLC7e0b56ef-fa41-4862-b387-5b58d81d67d42026-07-22WarningsExact identifier
application number: M016
Aveeno Soothing Bath TreatmentOATMEALKenvue Brands LLC0c410b8e-025f-477c-afac-6e2e9ac88f7d2026-07-21WarningsExact identifier
application number: M016
DERMFREE SCAR SHEETSSILICONE GEL 1% SCAR SHEETSJiangxi Yudexi Pharmaceutical Co., LTD4a4ce316-4b92-7e81-e063-6294a90af6db2026-07-21WarningsExact identifier
application number: M016
DERMFREE VARICOSE VEINSDIMETHICONE 3% VARICOSE VEINSJiangxi Yudexi Pharmaceutical Co., LTD4a5a2d1d-9e84-18eb-e063-6394a90a97ee2026-07-21WarningsExact 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