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 134 of 152 · 3,029 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Dermachange Arthritis ReliefTROLAMIN SALICYLATEPrivate Beauty Label and Wellness12dbfa50-1b97-f988-e063-6394a90a662c2024-03-04WarningsExact identifier
application number: M017
AnalgesicMENTHOLSafetec of America, Inc.b0f4010c-995f-40e1-aa40-92760e697a612024-03-02WarningsExact identifier
application number: M017
Icy Hot Advanced ReliefCAMPHOR AND MENTHOLChattem, Inc.9979ff36-415b-44e4-bb10-6bf682cd00f92024-03-01WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLC5051b650-18a4-481e-a8d7-d41d4ae51efd2024-02-29WarningsExact identifier
application number: M017
HydrocortisoneHYDROCORTISONETRIFECTA PHARMACEUTICALS USA LLC2999fecb-cb15-4023-ade4-ab5822b094d52024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8MENTHOLAmish Origins Management, LLCaaad56d5-6737-4edc-af0e-8e207695c0ec2024-02-29WarningsExact identifier
application number: M017
Amish Origins Pain Relieving Menthol 8%MENTHOLAmish Origins Management, LLCb120404f-5a07-4182-bb50-d943418622da2024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLC437491ca-60ff-4508-b408-f97e7152f6382024-02-29WarningsExact identifier
application number: M017
Amish Origins Topical Analgesic Camphor 2%CAMPHOR (SYNTHETIC)Amish Origins Management, LLCffe15aed-ea90-4db8-aace-d691a81c05ae2024-02-29WarningsExact identifier
application number: M017
LidoPro PatchLIDOCAINE, MENTHOL, AND METHYL SALICYLATEAdvanced Rx Pharmacy of Tennessee, LLC128d0ba9-bc9d-af16-e063-6394a90af5ef2024-02-29WarningsExact identifier
application number: M017
Leader Roll-On Cooling Pain Relief Topical AnalgesicMENTHOL, UNSPECIFIED FORMCardinal Health, 110 dba LEADERe86cba40-6b10-454d-98b3-6b547456eaad2024-02-29WarningsExact identifier
application number: M017
Maximum Strength Scalp Itch Relief Anti-itchHYDROCORTISONERite Aid55569563-fc38-4f97-8e74-9f96e31733842024-02-28WarningsExact identifier
application number: M017
Walgreens Eczema ReliefHYDROCORTISONE ACETATEWalgreen Co.4a65a1bf-aa24-4452-9ec3-a28c8bf0e47c2024-02-28WarningsExact identifier
application number: M017
meijer Cold Therapy Pain Relieving analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Incfb163112-d84d-418d-a410-3214c0ee4b5a2024-02-28WarningsExact identifier
application number: M017
SunBurnt PLUSLIDOCAINE HYDROCHLORIDEQuest Products, LLC.12128c75-015d-8a72-e063-6394a90ae00a2024-02-23WarningsExact identifier
application number: M017
Kroger Analgesic AnalgesicLIDOCAINE HYDROCHLORIDETHE KROGER COe6c5ead3-87d0-48ed-a4dc-86cf89ebb2852024-02-22WarningsExact identifier
application number: M017
Rugby Pain Relieving AnalgesicMENTHOL, UNSPECIFIED FORM AND METHYL SALICYLATEBryant Ranch Prepackfcf48536-224e-4a3d-9124-7700318239722024-02-22WarningsExact identifier
application number: M017
meijer ROLL-ON Cold Therapy Pain Relieving Topical analgesicMENTHOL, UNSPECIFIED FORMMeijer Distribution, Inc8bc3956b-b82d-4ed3-8bc3-db0078466bbc2024-02-22WarningsExact identifier
application number: M017
Promescent Delay WipesBENZOCAINEAbsorptionf0a5b6be-acc5-473c-9054-b9534e769db12024-02-20WarningsExact identifier
application number: M017
Ralli Rapid Pain ReliefMENTHOLTroy Manufacturing, Inc.721658dc-3b1d-43ff-9032-e96851633cf92024-02-19WarningsExact 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