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 128 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Real Time Pain Relief Maxx Topical AnalgesicMENTHOLREAL TIME PRODUCTS, INCf45eb95a-2813-4124-bdb0-54e078a8237d2024-08-20WarningsExact identifier
application number: M017
Theracare Lidocaine Pain reliefLIDOCAINEVeridian Healthcare1d8a3679-637d-94c0-e063-6294a90a9ecf2024-08-19WarningsExact identifier
application number: M017
LidoSyncLIDOCAINE, MENTHOLiON Pharma, LLC200f883c-439a-3b99-e063-6394a90aed102024-08-19WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil RefreshCAMPHOR, MENTHOLBorden Company (Private) Limited09243a23-1f17-f77b-e063-6394a90a0b222024-08-19WarningsExact identifier
application number: M017
CVS Health Maximum Strength Scalp Relief Anti-itchHYDROCORTISONECVS Healthb5ef0005-8b76-4205-8be0-db3a7ed7d1c42024-08-19WarningsExact identifier
application number: M017
Rite Aid Pain Relieving Roll-OnLIDOCAINE HCLRite Aid Corporation1406590c-667c-84eb-e063-6294a90a50522024-08-16WarningsExact identifier
application number: M017
NuviraCAPSAICIN 0.025%, MENTHOL 10%, METHYL NICOTINATE 0.25%, METHYL SALICYLATE 10%Strand Health Groupff448183-03cf-df2d-e053-6394a90a77f02024-08-16WarningsExact identifier
application number: M017
FLANAXMETHYL SALICYLATE, MENTHOL, CAPSAICINBelmora LLC5e06c688-a086-4c1c-8dab-fcead61fef402024-08-13WarningsExact identifier
application number: M017
Pain ReliefMENTHOLPain Relieving Spray Inc.1f44466f-044f-70fe-e063-6294a90ad5752024-08-09WarningsExact identifier
application number: M017
Meijer Cold Therapy Pain RelievingMENTHOLMeijer Inc1c5b55e3-f859-71b6-e063-6294a90a633b2024-08-08WarningsExact identifier
application number: M017
HealthWise Soothing Cold Therapy GelMENTHOL 4%Veridian Healthcare1f09ccdd-09d8-6a8d-e063-6394a90a184f2024-08-08WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONENantong Health & Beyond Hygienic Products Inc.fbbbcc67-b46d-d41a-e053-6294a90aa55d2024-08-08WarningsExact identifier
application number: M017
Cheezheng Pain Relief CreamMENTHOLTibet Cheezheng Tibetan Medicine Co. Ltd37279a3f-9207-4e4c-90d6-52735044f1042024-08-07WarningsExact identifier
application number: M017
CVS Health Hydrocortisone Anti ItchHYDROCORTISONECVS Health546a1b8a-8254-432a-85c4-38ebee5ad5682024-08-07WarningsExact identifier
application number: M017
SANTO REMEDIO Alivio Pain Relieving Lavender ScentLIDOCAINE HYDROCHLORIDE, MENTHOLSANTO REMEDIO LLCab53c7f2-a768-4f36-89d6-e128a1a940c22024-08-05WarningsExact identifier
application number: M017
CVS Health Maximum Strength HydrocortisoneHYDROCORTISONE OINTMENTCVS Healthee9ed7ca-1642-4cf6-ae4b-d1c11b37eaf32024-08-02WarningsExact identifier
application number: M017
Anti-Itch Vulva Cream 1 Hydrocortisone AcetateHYDROCORTISONE ACETATEThe Honey Pot Company LLC6f32b536-6ebf-49a8-abb6-2a1daae2f6d72024-08-01WarningsExact identifier
application number: M017
Anti Itch Soothing 1 Pramoxine HydrochloridePRAMOXINE HYDROCHLORIDEThe Honey Pot Company LLC8bfeea34-25d5-4721-a17f-d9f1d0084cc32024-08-01WarningsExact identifier
application number: M017
AVON footworks Arthritis Achy Foot and MuscleMETHYL SALICYLATEThe Avon Company1f440f60-cfc4-511e-e063-6294a90a87db2024-08-01WarningsExact identifier
application number: M017
AVON footworks Maximum Strength Cracked HeelBENZALKONIUM CHLORIDE, LIDOCAINEThe Avon Company1f45752e-4a55-431e-e063-6294a90aa57a2024-08-01WarningsExact 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