FDA.reportPublic FDA data

Monistat Care Instant Itch Relief

Product NDC
63736-050
11-digit product format
637360050
Labeler code
63736
Product ID
63736-050_24484604-8fe8-4781-84b7-2c0ab32800cc
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine
Dosage form
SPRAY
Route
TOPICAL
Labeler
Insight Pharmaceuticals LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-10-01
Substance
BENZOCAINE
Active strength
11.4 g/57g
Pharmacologic classes
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
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
Monistat Care Instant Itch Relief
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE11.4 g/57g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
360349Internal RxNorm lookup
1991422Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4e9dc791-419f-4c79-aed4-760f8c17a5ddAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63736-050-01Monistat Care Instant Itch Relief57 g in 1 CANSPRAY572

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63736-050MONISTAT CARE INSTANT ITCH RELIEF (BENZOCAINE) SPRAY [INSIGHT PHARMACEUTICALS LLC]2Current NDC, Legacy NDC, 1 package rows20241211_4e9dc791-419f-4c79-aed4-760f8c17a5dd.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 120 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Alocane MaxLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products LLC0a35ac19-6883-a733-e063-6294a90ad22d2024-11-05WarningsExact identifier
application number: M017
Alocane PlusLIDOCAINE HYDROCHLORIDE AND BENZALKONIUM CHLORIDEQuest Products, Inc.cfe8114b-df65-064b-e053-2a95a90a33f62024-11-05WarningsExact identifier
application number: M017
Alocane BotanicalsLIDOCAINE HYDROCHLORIDEQuest Products, LLC.02a8e5c7-56f4-eb0d-e063-6294a90a80cd2024-11-05WarningsExact identifier
application number: M017
Alocane Emergency Burn PadsLIDOCAINE HYDROCHLORIDEQuest Products, Inc.fe58bb89-7216-4121-afd3-d1438bdfbfa22024-11-05WarningsExact identifier
application number: M017
Licefreee AfterLicePRAMOXINE HCITec Laboratories Inc.06c4cc42-a215-3949-e063-6394a90a665e2024-11-05WarningsExact identifier
application number: M017
Antibacterial Lidocaine Wound GelBENZALKONIUM CHLORIDE, LIDOCAINE HYDROCHLORIDEASO LLCcb9505b7-222d-3a24-e053-2a95a90a0b642024-11-05WarningsExact identifier
application number: M017
TopCare Pain Relieving AnalgesicLIDOCAINE HYDROCHLORIDETopco Associates LLC6b4783e0-1987-4838-9e8c-b95426d62b282024-11-05WarningsExact identifier
application number: M017
Eagle Green BalmCAMPHOR MENTHOLBorden Company (Private) Limited6f7a796b-a31c-0e60-e053-2a91aa0a022b2024-11-04WarningsExact identifier
application number: M017
Muscular BalmCAPSAICIN MENTHOL METHYL SALICYLATEBorden Company (Private) Limiteded79f14e-6b3d-4bf2-9c34-d019c1ba25822024-11-04WarningsExact identifier
application number: M017
Hydrocortisone with AloeHYDROCORTISONEA-S Medication Solutions3e0aed2b-fee1-4a0c-a3d2-72cd2b3008e32024-11-04WarningsExact identifier
application number: M017
Walgreens Ice Blue Pain Relieving Topical AnalgesicMENTHOL, UNSPECIFIED FORMWalgreen Company1c0ee442-ffd2-4f6c-aab2-f70e295378ad2024-11-04WarningsExact identifier
application number: M017
Walgreen Cool n Heat Maximum Strength Pain RelievingMENTHOL, UNSPECIFIED FORMWalgreen Companyd5c79476-dde8-4a85-8878-bc2ac3a3d70b2024-11-04WarningsExact identifier
application number: M017
LIDOCAINELIDOCAINESTRATUS PHARMACEUTICALS INC87a4f559-a4f6-4b9f-98de-b55b073a11c62024-11-01WarningsExact identifier
application number: M017
Walgreens Nerve Pain Relieving Topical AnalgesicLIDOCAINE HYDROCHLORIDE AND MENTHOL, UNSPECIFIED FORMWalgreen Company83849eca-e02f-4b43-b3a7-b25e987e08a82024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica WhiteCAMPHORSanvall Enterprises, Inc192039a2-aed6-821b-e063-6394a90a7f292024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica ReforzadaCAMPHORSanvall Enterprises, Inc1921a4b1-cd36-195e-e063-6294a90a87932024-10-31WarningsExact identifier
application number: M017
Sanar Naturals Arnica Pain Releiving Roll On with CamphorCAMPHORSanvall Enterprises, Inc173db0e2-611f-55b9-e063-6394a90ac9872024-10-31WarningsExact identifier
application number: M017
Sanar Naturals CamphorCAMPHORSanvall Enterprises, Inc1921e851-cf83-0bdb-e063-6294a90a357f2024-10-31WarningsExact identifier
application number: M017
cortisoneHYDROCORTISONECVS Pharmacyc766deac-d993-4e48-a5c3-4cfde7338dff2024-10-31WarningsExact identifier
application number: M017
Walgreens Pain Relieving with Lavender AnalgesicLIDOCAINE HYDROCHLORIDEWalgreen Company6c7b39c8-5b65-430a-a529-5b6b14adce182024-10-31WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
360349benzocaine 20 % Topical SprayPSN4e9dc791-419f-4c79-aed4-760f8c17a5dd2
1991422Monistat Care Instant Itch Relief 20 % Topical SprayPSN4e9dc791-419f-4c79-aed4-760f8c17a5dd2
1991422benzocaine 200 MG/ML Topical Spray [Monistat Care]SBD4e9dc791-419f-4c79-aed4-760f8c17a5dd2
360349benzocaine 200 MG/ML Topical SpraySCD4e9dc791-419f-4c79-aed4-760f8c17a5dd2
360349benzocaine 20 % Topical SpraySY4e9dc791-419f-4c79-aed4-760f8c17a5dd2
1991422Monistat Care 20 % Topical SpraySY4e9dc791-419f-4c79-aed4-760f8c17a5dd2
1991422Monistat Care 200 MG/ML Topical SpraySY4e9dc791-419f-4c79-aed4-760f8c17a5dd2

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
63736-050-016373600500157 g in 1 CAN (63736-050-01) 57 g2017-10-010000-00-00NoNoCurrent