FDA.reportPublic FDA data

Feminine Anti Itch Cream

Product NDC
69396-183
11-digit product format
693960183
Labeler code
69396
Product ID
69396-183_50c3acdd-43a2-09fd-e063-6394a90a7e63
Type
HUMAN OTC DRUG
Nonproprietary name
Benzocaine,Resorcinol
Dosage form
CREAM
Route
TOPICAL
Labeler
TRIFECTA PHARMACEUTICALS USA LLC
Application
M017
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-30
Substance
BENZOCAINE; RESORCINOL
Active strength
20; 3 g/100g; g/100g
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
Feminine Anti Itch Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
BENZOCAINE20 g/100g
RESORCINOL3 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
U3RSY48JW5Internal UNII lookup
YUL4LO94HKInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
637518Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
50c3acbf-b873-908a-e063-6294a90a66b7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
60c52429-fcef-eb54-2387-43bc9e4f296bProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-183-01Feminine Anti Itch Cream1 in 1 BOXCREAM11
69396-183-01Feminine Anti Itch Cream28.4 g in 1 TUBECREAM28.41
69396-183-33Feminine Anti Itch Cream3 in 1 BOXCREAM31
69396-183-33Feminine Anti Itch Cream28.4 g in 1 TUBECREAM28.41

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 133 of 153 · 3,057 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
TheraCare 4% Lidocaine CreamLIDOCAINE HYDROCHLORIDEVeridian Healthcarec808aa05-9d49-cc9f-e053-2a95a90a50f32024-05-21WarningsExact identifier
application number: M017
TheraCare 4% Lidocaine and 1% Menthol CreamMENTHOL AND LIDOCAINEVeridian Healthcarec80ba251-91a5-0858-e053-2995a90a9cff2024-05-21WarningsExact identifier
application number: M017
HealthWise Menthol Roll-OnMENTHOLVeridian Healthcare102d57a5-6449-f825-e063-6294a90a88442024-05-21WarningsExact identifier
application number: M017
SAFLY BurnLIDOCAINE HYDROCHLORIDENantong Health & Beyond Hygienic Products Inc.3aca2568-d10f-4b14-861b-6c741c1068292024-05-17WarningsExact identifier
application number: M017
HealthWise Menthol 4% Roll-OnMENTHOLVeridian Healthcare1894ef00-ba05-0e02-e063-6394a90ab9822024-05-16WarningsExact identifier
application number: M017
Leader Poison Ivy WashPRAMOXINE HYDROCHLORIDE LOTIONCardinal Health, 110 dba Leader81f2ecb0-c3ce-d2f8-e053-2a91aa0add0c2024-05-13WarningsExact identifier
application number: M017
Eagle Brand Medicated Oil AromaticCAMPHOR, MENTHOL, METHYL SALICYLATEBorden Company (Private) Limited0e808f89-62dc-3790-e063-6394a90a23512024-05-13WarningsExact identifier
application number: M017
Walgreens Lidocaine Plus CreamBENZYL ALCOHOL AND LIDOCAINE HYDROCHLORIDEWalgreens Companye33e0097-31d6-8083-e053-2a95a90af5d22024-05-09WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Pain Relieving Cold GelCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1794c512-5f42-4ec3-e063-6394a90a87cd2024-05-03WarningsExact identifier
application number: M017
Professional Therapy MuscleCare ProMENTHOL AND CAMPHORACTIVE AND INNOVATIVE, LLC17961a84-6bee-c75f-e063-6394a90af5762024-05-03WarningsExact identifier
application number: M017
Aspercreme with Lidocaine Pain Relieving CremeLIDOCAINE HYDROCHLORIDEChattem, Inc.d5da67c3-c2ec-4e3e-abe9-cc862dcfc8bd2024-05-01WarningsExact identifier
application number: M017
Lidocaine HCl 4 PercentLIDOCAINE HYDROCHLORIDEARI BRANDS, LLC81aff5c5-91c0-4173-a432-d201156135802024-04-30WarningsExact identifier
application number: M017
HealthWise 3x Medicated Pain Relief Patch 120 BulkCAMPHOR,MENTHOL, METHYL SALICYLATEVeridian Healthcare17545078-05e1-9338-e063-6394a90a678c2024-04-30WarningsExact identifier
application number: M017
Professional Therapy MuscleCare Pro Roll-onCAMPHOR, MENTHOLACTIVE AND INNOVATIVE, LLC1755ec89-c404-1c17-e063-6394a90ab9fb2024-04-30WarningsExact identifier
application number: M017
PAIN RELIEF Gel-Roll OnMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bc2a14-6bda-428c-e053-2995a90a4ced2024-04-29WarningsExact identifier
application number: M017
PAIN RELIEF Gel-TubeMENTHOLShanghai Chuangshi Medical Technology (Group) Co., Ltd.f0bec1d4-2e18-4519-e053-2a95a90a1bbb2024-04-29WarningsExact identifier
application number: M017
THERAPLEX AIM Anti-Itch MoisturizingHYDROCORTISONETHERAPLEX, LLCd1b231b6-cc9f-488a-9121-5018314737722024-04-27WarningsExact identifier
application number: M017
HYDROCORTISONEHYDROCORTISONE ACETATEJHK Inc dba American Safety & First Aid64adc8d0-7ca4-4c1a-813f-f1df47e916f22024-04-25WarningsExact identifier
application number: M017
HealthWise Lidocaine Plus CreamBENZYL ALCOHOL, LIDOCAINE HYDROCHLORIDEVeridian Healthcare16f26249-b508-2c6e-e063-6394a90a265b2024-04-25WarningsExact identifier
application number: M017
Hydrocortisone Cream with AloeHYDROCORTISONECardinal Health 110 dba LEADER16f2f3cb-4611-5867-e063-6394a90af1072024-04-25WarningsExact identifier
application number: M017

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamPSN50c3acbf-b873-908a-e063-6294a90a66b71
637518benzocaine 200 MG/ML / resorcinol 30 MG/ML Vaginal CreamSCD50c3acbf-b873-908a-e063-6294a90a66b71
637518benzocaine 20 % / resorcinol 3 % Vaginal CreamSY50c3acbf-b873-908a-e063-6294a90a66b71

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-183-01693960183011 TUBE in 1 BOX (69396-183-01) / 28.4 g in 1 TUBE1 tube2026-05-01NoNoCurrent
69396-183-33693960183333 TUBE in 1 BOX (69396-183-33) / 28.4 g in 1 TUBE3 tube2026-05-01NoNoCurrent