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

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 Identifiers#

Field, Values table
FieldValues
UniiU3RSY48JW5, YUL4LO94HK
Rxcui637518

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

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