FDA.reportPublic FDA data

RectaEase Hemorrhoid Relief Cream

Product NDC
69396-070
11-digit product format
693960070
Labeler code
69396
Product ID
69396-070_57165430-c79f-2013-e063-6294a90a03be
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
CREAM
Route
TOPICAL
Labeler
Trifecta Pharmaceuticals USA LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-04-19
Substance
LIDOCAINE
Active strength
50 mg/g
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
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
RectaEase Hemorrhoid Relief Cream
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE50 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal UNII lookup

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
1366789Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
c054921a-9f1b-7c75-e053-2995a90a1738Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-070-01RectaEase Hemorrhoid Relief Cream1 in 1 BOXCREAM16
69396-070-01RectaEase Hemorrhoid Relief Cream28 g in 1 TUBECREAM286
69396-070-22RectaEase Hemorrhoid Relief Cream2 in 1 BOXCREAM26
69396-070-22RectaEase Hemorrhoid Relief Cream28 g in 1 TUBECREAM286
69396-070-33RectaEase Hemorrhoid Relief Cream28 g in 1 TUBECREAM286
69396-070-33RectaEase Hemorrhoid Relief Cream3 in 1 BOXCREAM36

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-070RECTAEASE HEMORRHOID RELIEF CREAM (LIDOCAINE) CREAM [TRIFECTA PHARMACEUTICALS USA LLC]4Current NDC, Legacy NDC, 6 package rows20240229_c054921a-9f1b-7c75-e053-2995a90a1738.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 4 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
application number: M015
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.53f11395-f460-943f-e063-6294a90affef2026-06-10WarningsExact identifier
application number: M015
Terramed Just Think Comfort Hemorrhoidal WipesLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDERida LLCf6ad00e7-c7b8-40b8-80c2-6e6bf85098b32026-06-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELCVS Pharmacy, Inc.50f920da-b41a-480d-b3a0-df940caaee2d2026-06-08Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
application number: M015
Healcome Lidocaine Numbing CreamLIDOCAINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD9b4eac02-1b1f-4630-92b4-b1d8c21abab52026-05-29WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomileTOLNAFTATERida LLC5517c43f-03b2-499a-a217-d9cba3fb9fd22026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash CitrusTOLNAFTATERida LLCb4c5da66-5928-4352-ab90-fd46039e79552026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate WipesPRAMOXINE HYDROCHLORIDERida LLCbb29f156-37b8-400e-802b-3e2671cb7dc82026-05-27WarningsExact identifier
application number: M015
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool MentholTOLNAFTATERida LLC8b15cb3b-f7cb-4a80-94b2-eeeafc9794e82026-05-27WarningsExact identifier
application number: M015
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsExact identifier
application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) CreamLIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAMJiangxi Yudexi Pharmaceutical Co., LTD52a25b97-7721-6410-e063-6394a90a228f2026-05-25WarningsExact identifier
application number: M015
Arlun LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5241c26b-6c91-65a5-e063-6394a90a24772026-05-20WarningsExact identifier
application number: M015
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5223b7fe-6aba-c77b-e063-6394a90ad27b2026-05-18WarningsExact identifier
application number: M015
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.51cd58f7-c1c9-f4e2-e063-6294a90ad9702026-05-14WarningsExact identifier
application number: M015
Lidocaine anorectal creamLIDOCAINE 5%EveryMarket Inc1604daec-812f-4684-ba98-fbcda07a74612026-05-12WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPESWITCH HAZELHaleon US Holdings LLC485437a8-b2e9-4acf-a20e-edb1f08a9cae2026-05-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1366789lidocaine 5 % Rectal CreamPSNc054921a-9f1b-7c75-e053-2995a90a17386
1366789lidocaine 50 MG/ML Rectal CreamSCDc054921a-9f1b-7c75-e053-2995a90a17386
1366789lidocaine 5 % Rectal CreamSYc054921a-9f1b-7c75-e053-2995a90a17386

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
69396-070-01693960070011 TUBE in 1 BOX (69396-070-01) / 28 g in 1 TUBE1 tube2021-04-190000-00-00NoNoCurrent
69396-070-22693960070222 TUBE in 1 BOX (69396-070-22) / 28 g in 1 TUBE2 tube2026-03-04NoNoCurrent
69396-070-33693960070333 TUBE in 1 BOX (69396-070-33) / 28 g in 1 TUBE3 tube2026-03-04NoNoCurrent