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 59 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Thera Plus Maximum Strength HydrocortisoneHYDROCORTISONEFourstar Group USA, Inc7d4e21d1-2914-4690-9084-a52abeab09582025-12-02WarningsExact identifier
application number: M017
Rugby Capsaicin CreamCAPSAICINRugby Laboratories9eca34f1-e91a-3ac1-e053-2a95a90a9bd92025-12-02WarningsExact identifier
application number: M017
Leader Capsaicin Pain Relief CreamCAPSAICINCardinal Health 110 dba LEADERa5620709-0fed-4979-e053-2a95a90ac6542025-12-02WarningsExact identifier
application number: M017
Hydrocortisone Acetate Antipruritic (Anti-Itch)HYDROCORTISONE ACETATESun Pharmaceutical Industries, Inc.9f0b09e7-6cfd-4fd6-8631-67799edf4e082025-12-02WarningsExact identifier
application number: M017
POMG NIGHT TIME PAIN RELIEF ROLLERLIDOCAINE HYDROCHLORIDEPOMG LLC28d7dfb0-a94c-90de-e063-6294a90a036a2025-12-02WarningsExact identifier
application number: M017
Thermacare Max Strength LidocaineTHERMACARE MAX STRENGTH LIDOCAINEClarion Brands LLC44fed887-d1e0-d205-e063-6294a90ac4162025-12-02WarningsExact identifier
application number: M017
SUNSET COOLING PAIN RELIEF ROLL-ONMENTHOLSUNSET NOVELTIES, INC45037bc1-aa03-11ae-e063-6294a90a6c962025-12-02WarningsExact identifier
application number: M017
SUNSET HEATING PAIN RELIEF ROLL-ONCAMPHORSUNSET NOVELTIES, INC45048936-f3c9-25f7-e063-6394a90ac4a92025-12-02WarningsExact identifier
application number: M017
CAREALL Anti-ItchDIPHENHYDRAMINE HYDROCHLORIDE AND ZINC ACETATE CREAMNew World Imports, Inc3a01f57a-ebc6-4724-b625-1d1ea4b85e732025-12-01WarningsExact identifier
application number: M017
CareALL Arthritis and MuscleCAPSAICINNew World Imports, Inc4867eac4-00ea-434e-b289-1c1ef0342c232025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Ince2df8130-e7c8-4fde-a6d6-c713789912132025-12-01WarningsExact identifier
application number: M017
CAREALL Hydrocortisone Maximum StrengthHYDROCORTISONENew World Imports, Incd04e473d-8bbc-475c-a0b1-ca5eed67fbc72025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Inccba7c084-379f-4a16-aeba-b11ca6e20d8a2025-12-01WarningsExact identifier
application number: M017
CAREALL Muscle Rub Ultra StrengthMENTHOL, METHYL SALICYLATENew World Imports, Incd066002d-8ceb-4d16-9744-d5ca25d2ad5a2025-12-01WarningsExact identifier
application number: M017
CAREALL Musle and JointMENTHOLNew World Imports, Inc013beea4-b2c2-4e84-b4cb-3125ac48e8c02025-12-01WarningsExact identifier
application number: M017
Capsaicin CreamCAPSAICINA2A Integrated Pharmaceuticals, LLC147f3594-7362-7a78-e063-6294a90a3e422025-11-30WarningsExact identifier
application number: M017
Aquanil HCHYDROCORTISONEPerson and Covey6b9258e4-c7c4-765e-e053-2991aa0a9f4e2025-11-29WarningsExact identifier
application number: M017
Walgreen Pain Relieving Fragrance FreeLIDOCAINE HYDROCHLORIDEWALGREENS CO.62c50ded-3fc9-4f65-9bfb-1144ed2e36b42025-11-26WarningsExact identifier
application number: M017
Itch ReliefITCH RELIEF GELNeilmed Pharmaceuticals Inc.44811828-c32e-17fc-e063-6294a90add482025-11-26WarningsExact identifier
application number: M017
Thermacare Heat Therapy Max Strength Lidocaine Pain Relief RollonTHERMACARE HEAT THERAPY MAX STRENGTH LIDOCAINE PAIN RELIEF ROLLONClarion Brands LLC4482d34d-eaca-5522-e063-6394a90a6afb2025-11-26WarningsExact 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