FDA.reportPublic FDA data

Hemorrhoidal Cream with Lidocaine

Product NDC
69396-181
11-digit product format
693960181
Labeler code
69396
Product ID
69396-181_4f1ef997-92ad-842f-e063-6294a90aab3f
Type
HUMAN OTC DRUG
Nonproprietary name
Glycerol, Phenylephine, Pramoxine, Petrolatum
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals Usa Llc
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2026-04-10
Substance
LIDOCAINE; WHITE PETROLATUM; GLYCERIN; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; 15; 14.4; .25 g/100g; g/100g; g/100g; g/100g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC], alpha-1 Adrenergic Agonist [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
Hemorrhoidal Cream with Lidocaine
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100g
WHITE PETROLATUM15 g/100g
GLYCERIN14.4 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 4 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup
B6E5W8RQJ4Internal UNII lookup
PDC6A3C0OXInternal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
2642220Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
4f1ef866-c4af-989b-e063-6294a90a148eAvailable on FDA.report

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
69396-181-01Hemorrhoidal Cream with Lidocaine28 g in 1 TUBECREAM281
69396-181-01Hemorrhoidal Cream with Lidocaine1 in 1 BOXCREAM11
69396-181-03Hemorrhoidal Cream with Lidocaine28 g in 1 TUBECREAM281
69396-181-03Hemorrhoidal Cream with Lidocaine3 in 1 BOXCREAM31

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 8 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Hemorrhoid, Fissure, ProctalgiaSuppositoriesCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOLWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1d40d16a-ee52-463a-e063-6394a90a60772026-01-14WarningsExact identifier
application number: M015
Hemorrhoid, Fissure, Proctalgia Relief WashCARBON, PANTHENOL, SODIUM HYALURONATEWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1e20de39-45b0-54ec-e063-6294a90a04ed2026-01-14WarningsExact identifier
application number: M015
Hemorrhoid, Fissure, Proctalgia OintmentsCARBON, MIRABILITE, PEPPERMINT OIL, BORNEOL, GLYCERINWU XI ZHONG ZHI WEI NA TECHNOLOGY CO., Ltd.1efe43d5-a29b-5cb2-e063-6394a90aca662026-01-14WarningsExact identifier
application number: M015
LONAZEMMENTHOL,PETROLATUMPEER PHARM LTD.91f7a741-4178-4639-9cd5-746a4b9a21bf2026-01-12WarningsExact identifier
application number: M015
Hemorrhoidal Hygiene padsWITCH HAZELAkron Pharma Inc.936a0cca-5049-4ddf-9581-75c2da6d9cfa2026-01-12WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD4805ba4e-45d3-bf0a-e063-6294a90a6eef2026-01-10WarningsExact identifier
application number: M015
THE SOLUTION 2.0LIDOCAINESCALP TECH INC0fa423b6-cc0f-b569-e063-6294a90a239e2026-01-09WarningsExact identifier
application number: M015
BLACK LABEL B NUMBLIDOCAINE HYDROCHLORIDESCALP TECH INC11fcf401-0891-04bc-e063-6294a90a8ad52026-01-09WarningsExact identifier
application number: M015
GOLD LABEL B NUMBLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INC1211590a-13b5-2e75-e063-6394a90a0f862026-01-09WarningsExact identifier
application number: M015
0.25 % PHENYLEPHRINE HCl HEMORRHOIDALMINERAL OIL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEUniversal Distribution Center LLC90844919-f16a-4390-9dca-b0405b5014452026-01-08WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47dda425-86d8-441e-e063-6294a90a0f9a2026-01-08WarningsExact identifier
application number: M015
AER Traveler ToweletteAER TRAVELERBirchwood Laboratories LLC26556b9b-1c3a-6cf5-e063-6394a90ab26c2026-01-08WarningsExact identifier
application number: M015
Preparation H Rapid ReliefGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC49a93cfc-4ccd-4ef3-928f-901b9926f7942026-01-08WarningsExact identifier
application number: M015
PREPARATION H FOR WOMENWITCH HAZELHaleon US Holdings LLCa9099cf4-4e2e-4cf1-a52f-48f8e174cb152026-01-08WarningsExact identifier
application number: M015
LIPOCAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.849d6e28-a6b8-7f49-e053-2a91aa0a497d2026-01-08WarningsExact identifier
application number: M015
TOPICAINE 5LIDOCAINE 5%ESBA LABORATORIES INC.15d33ff7-34ed-253d-e054-00144ff88e882026-01-08WarningsExact identifier
application number: M015
Dr Wellskin Numbing Cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47ebedc5-caf1-a774-e063-6394a90ae14d2026-01-08WarningsExact identifier
application number: M015
Dr. Care Numbing CreamLIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD47c94198-7718-bbc2-e063-6294a90a48f12026-01-07WarningsExact identifier
application number: M015
Healthwise Anorectal Pain ReliefLIDOCAINE 5%Veridian Healthcare19c24e1b-a31b-478b-a48b-c39bb4753ca72026-01-06WarningsExact identifier
application number: M015
Good Sense Hemorrhoidal Maximum Strength Pain ReliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUML. Perrigo Company1d6142b6-3746-46f1-99ec-4b19d26f056e2026-01-06WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamPSN4f1ef866-c4af-989b-e063-6294a90a148e1
2642220glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD4f1ef866-c4af-989b-e063-6294a90a148e1
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamSY4f1ef866-c4af-989b-e063-6294a90a148e1

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
69396-181-01693960181011 TUBE in 1 BOX (69396-181-01) / 28 g in 1 TUBE1 tube2026-04-10NoNoCurrent
69396-181-03693960181033 TUBE in 1 BOX (69396-181-03) / 28 g in 1 TUBE3 tube2026-04-10NoNoCurrent