Monistat Complete Care Instant Itch Relief

Product NDC
63736-029
11-digit product format
637360029
Labeler code
63736
Product ID
63736-029_64f600d5-5dd6-49c6-bcd4-43a64cbd6712
Type
HUMAN OTC DRUG
Nonproprietary name
hydrocortisone
Dosage form
CREAM
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2013-11-15
Substance
HYDROCORTISONE
Active strength
1 g/100g
Pharmacologic classes
Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC]
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 Instant Itch Relief
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
HYDROCORTISONE1 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
WI4X0X7BPJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1494032Internal RxNorm lookup
1494035Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a0f40504-6183-4f32-8d17-6586b3f386a6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-029-01Monistat Complete Care Instant Itch Relief28 g in 1 TUBECREAM284
63736-029-01Monistat Complete Care Instant Itch Relief1 in 1 CARTONCREAM14

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
hydrocortisoneACTIVE INGREDIENTWI4X0X7BPJMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
HydrocortisoneACTIVE MOIETYWI4X0X7BPJMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
ammonium acryloyldimethyltaurate/VP copolymerINACTIVE INGREDIENTW59H9296ZGMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
carbomer homopolymer type A (allyl pentaerythritol crosslinked)INACTIVE INGREDIENTF68VH75CJCMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
ceteareth-6INACTIVE INGREDIENT2RJS3559D3MONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
cetyl alcoholINACTIVE INGREDIENT936JST6JCNMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
citric acid monohydrateINACTIVE INGREDIENT2968PHW8QPMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
dimethiconeINACTIVE INGREDIENT92RU3N3Y1OMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
edetate disodiumINACTIVE INGREDIENT7FLD91C86KMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
ethylparabenINACTIVE INGREDIENT14255EXE39MONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
glycerinINACTIVE INGREDIENTPDC6A3C0OXMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
methylparabenINACTIVE INGREDIENTA2I8C7HI9TMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
mineral oilINACTIVE INGREDIENTT5L8T28FGPMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
petrolatumINACTIVE INGREDIENT4T6H12BN9UMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
phenoxyethanolINACTIVE INGREDIENTHIE492ZZ3TMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
propylparabenINACTIVE INGREDIENTZ8IX2SC1OHMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
sodium citrateINACTIVE INGREDIENT1Q73Q2JULRMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
sodium hydroxideINACTIVE INGREDIENT55X04QC32IMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
stearyl alcoholINACTIVE INGREDIENT2KR89I4H1YMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1
WaterINACTIVE INGREDIENT059QF0KO0RMONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-029MONISTAT COMPLETE CARE INSTANT ITCH RELIEF (HYDROCORTISONE) CREAM [INSIGHT PHARMACEUTICALS LLC]4Current NDC, Legacy NDC, 2 package rows20241113_a0f40504-6183-4f32-8d17-6586b3f386a6.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 155 · 3,098 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Inknows Lidocaine Pain Relief Gel-PatchLIDOCAINE PAIN RELIEF GEL-PATCHHenan Enokon Medical Instrument Co., Ltd.59eb9c12-9e00-0171-e063-6394a90a83422026-08-25WarningsExact identifier
application number: M017
LidomarLIDOMAROncora Pharma, LLC215bfdca-60bf-480b-b02e-902de52fe5e82026-08-25WarningsExact identifier
application number: M017
HEEL PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c7e13f-b9ea-023a-e063-6294a90a79e02026-08-24WarningsExact identifier
application number: M017
KNEE PAIN RELIEF ROLL-ONLIDOCAINE AND MENTHOLGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.59c8b33a-7d4f-2c6e-e063-6394a90a79292026-08-24WarningsExact identifier
application number: M017
Bovonte Numbing CreamNUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5958cc29-c449-56a7-e063-6394a90a960b2026-08-24WarningsExact identifier
application number: M017
JELVOXA NECK PAIN RELIEVINGMENTHOLWuhan Ruihengjie Technology Co., Ltd.59a3d60a-26b5-e6a6-e063-6294a90a42bd2026-08-22WarningsExact identifier
application number: M017
JELVOXA DMSOCAMPHOR CAPSAICIN MENTHOLWuhan Ruihengjie Technology Co., Ltd.59a43e2c-d258-34b5-e063-6394a90a09bf2026-08-22WarningsExact identifier
application number: M017
Capsaicin 0.035 PercentCAPSAICINPreferred Pharmaceuticals Inc.0fabc025-4208-45f5-b3c2-543ae3a2df412026-08-21WarningsExact identifier
application number: M017
ClaravieHYDROCORTISONE ACETATEGentell LLC598d224b-d12e-89bf-e063-6394a90a84dc2026-08-21WarningsExact identifier
application number: M017
ETERNAL SPIRIT BEAUTY PAINLESS PAIN RELIEVINGMENTHOL, CAMPHORWorldwide Cosmetics, Inc3b8c2419-7a78-2731-e054-00144ff8d46c2026-08-21WarningsExact identifier
application number: M017
Enokon Lidocaine Pain Relief PatchLIDOCAINE PAIN RELIEF PATCHHenan Enokon Medical Instrument Co., Ltd.5976e667-e506-1d11-e063-6394a90a68092026-08-20WarningsExact identifier
application number: M017
MQUPIN TIGER PatchTIGER PATCHZhengzhou Miaoqi Medical Technology Co., Ltd.5977cbb5-94c7-cb24-e063-6294a90a2e072026-08-20WarningsExact identifier
application number: M017
MQUPIN Nicotine PatchesNICOTINE PATCHESZhengzhou Miaoqi Medical Technology Co., Ltd.5978258a-549e-50e6-e063-6394a90a3d862026-08-20WarningsExact identifier
application number: M017
ClaravieCAMPHORGentell LLC5978bdab-5359-be9a-e063-6394a90a5a322026-08-20WarningsExact identifier
application number: M017
Rugby PAIN RELIEF PATCHESLIDOCAINERUGBY LABORATORIESb34e40c8-a257-46cf-9399-f55df9b4102d2026-08-20WarningsExact identifier
application number: M017
MAXIMUM STRENGTH Lidocaine Plus MentholLIDOCAINE, MENTHOLARMY AND AIR FORCE EXCHANGE SERVICE60f72061-d264-424e-b396-5a609076d3522026-08-20WarningsExact identifier
application number: M017
MENTHOL, CAMPHORMENTHOL, CAMPHORSUNSET PAIN RELIEF5980c527-6bcb-a846-e063-6294a90a07882026-08-20WarningsExact identifier
application number: M017
Pain Relief PatchesCAMPHOR, MENTHOL, METHYL SALICYLATEAmerisource Bergen5fb5e5ce-b268-4444-8b63-ea7ea6abf2692026-08-20WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC58c2b35c-e1ed-7ea8-e063-6294a90a14942026-08-19WarningsExact identifier
application number: M017
Dr. Scholls Blister Pain Relief Complete KitLIDOCAINEScholl's Wellness Company LLC585e740b-e4fa-d2aa-e063-6294a90a09822026-08-19WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1494032hydrocortisone 1 % Vaginal CreamPSNa0f40504-6183-4f32-8d17-6586b3f386a64
1494035MONISTAT Complete Care 1 % Topical CreamPSNa0f40504-6183-4f32-8d17-6586b3f386a64
1494035hydrocortisone 10 MG/ML Vaginal Cream [Monistat Itch Relief]SBDa0f40504-6183-4f32-8d17-6586b3f386a64
1494032hydrocortisone 10 MG/ML Vaginal CreamSCDa0f40504-6183-4f32-8d17-6586b3f386a64
1494035Monistat Complete Care Itch Relief 1 % Vaginal CreamSYa0f40504-6183-4f32-8d17-6586b3f386a64
1494035Monistat Itch Relief 10 MG/ML Vaginal CreamSYa0f40504-6183-4f32-8d17-6586b3f386a64
1494035Monistat Soothing Care Itch Relief 1 % Topical CreamSYa0f40504-6183-4f32-8d17-6586b3f386a64

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-029-01637360029011 TUBE in 1 CARTON (63736-029-01) / 28 g in 1 TUBE1 tube2013-11-150000-00-00NoNoCurrent