FDA.reportPublic FDA data

The Femme Fix Hemorrhoid Treatment

Product NDC
82433-946
11-digit product format
824330946
Labeler code
82433
Product ID
82433-946_35b65b6c-4694-b4f1-e063-6394a90a4325
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
OINTMENT
Route
TOPICAL
Labeler
POPPY COLLECTIVE LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2025-05-01
Substance
LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
40; 2.5 mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE], alpha-1 Adrenergic Agonist [EPC]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
The Femme Fix Hemorrhoid Treatment
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE40 mg/g
PHENYLEPHRINE HYDROCHLORIDE2.5 mg/g

Harmonized Identifiers#

Field, Values table
FieldValues
Unii98PI200987, 04JA59TNSJ
Rxcui2673304

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82433-946-00The Femme Fix Hemorrhoid Treatment28 g in 1 TUBEOINTMENT281
82433-946-00The Femme Fix Hemorrhoid Treatment1 in 1 BOXOINTMENT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82433-946THE FEMME FIX HEMORRHOID TREATMENT (LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE) OINTMENT [POPPY COLLECTIVE LLC]1Current NDC, 2 package rows20250529_5217b5d9-b835-4428-a6b3-e6b255630742.zip

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentPSN5217b5d9-b835-4428-a6b3-e6b2556307421
2673304lidocaine 0.04 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal OintmentSCD5217b5d9-b835-4428-a6b3-e6b2556307421
2673304lidocaine 4 % / phenylephrine HCl 0.25 % Rectal OintmentSY5217b5d9-b835-4428-a6b3-e6b2556307421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
82433-946-00824330946001 TUBE in 1 BOX (82433-946-00) / 28 g in 1 TUBE1 tube2025-05-01NoNoHistorical