FDA.reportPublic FDA data

Terramed Just Think Comfort Hemorrhoidal Wipes

Product NDC
83004-039
11-digit product format
830040039
Labeler code
83004
Product ID
83004-039_53c13688-28dd-c1d7-e063-6394a90a889d
Type
HUMAN OTC DRUG
Nonproprietary name
LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Dosage form
CLOTH
Route
TOPICAL
Labeler
Rida LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-12-12
Substance
LIDOCAINE; PHENYLEPHRINE HYDROCHLORIDE
Active strength
5; .25 g/100mL; g/100mL
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
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
Terramed Just Think Comfort Hemorrhoidal Wipes
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
LIDOCAINE5 g/100mL
PHENYLEPHRINE HYDROCHLORIDE.25 g/100mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
98PI200987Internal 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
2744830Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
f6ad00e7-c7b8-40b8-80c2-6e6bf85098b3Available on FDA.report

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 16 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CalmoseptineANORECTAL OINTMENTCalmoseptine Inc.ff9539ed-d9ae-401d-adbc-df8f1d7514312025-01-13WarningsExact identifier
application number: M015
DibucaineDIBUCAINEAkron Pharma Inc.60469e43-ab6f-46d3-a1df-00e58275f5652025-01-12WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIChain Drug Marketing Association Inc.2b490a08-149d-76ab-e063-6394a90a084f2025-01-09WarningsExact identifier
application number: M015
Drs. pharmacy HEMORRHOIDAL COOLINGPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACYd6f6b482-d85d-001c-e053-2995a90ad98c2025-01-09WarningsExact identifier
application number: M015
Hemorrhoidal Cream with AloeGLYCEROL, PHENYLEPHINE, PRAMOXINE, PETROLATUMChain Drug Marketing Association2b33c710-ac17-20f9-e063-6294a90ad29c2025-01-08WarningsExact identifier
application number: M015
THE SOLUTIONLIDOCAINE HYDROCHLORIDE, EPINEPHRINE HYDROCHLORIDESCALP TECH INCdf51623c-e0b6-8e86-e053-2995a90a59b22025-01-08WarningsExact identifier
application number: M015
frida mom Perineal Cooling Pad LinersWITCH HAZELFridababy, LLCa461ff3d-e115-4f15-a545-bacb502ff6cd2024-12-30WarningsExact identifier
application number: M015
frida mom Postpartum Recovery EssentialsWITCH HAZELFridababy, LLC2d26c6f2-5d31-4c07-9f40-2fbfcfbf12342024-12-30WarningsExact identifier
application number: M015
frida mom Perineal HealingWITCH HAZELFridababy, LLC6a58e2a8-c4d5-4078-b5f4-28504de1f0202024-12-30WarningsExact identifier
application number: M015
frida mom Labor and Delivery Plus Postpartum RecoveryWITCH HAZELFridababy, LLC4b5fc312-4c8c-4396-a70c-b1ed129038c72024-12-30WarningsExact identifier
application number: M015
Tucks Triple Relief HemorrhoidalWHITE PETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, AND PHENYLEPHRINE HYDROCHLORIDEBlistex Inc.bf892e90-2d9b-4fa0-8ee4-8a2736be6c302024-12-24WarningsExact identifier
application number: M015
BLISS GVS HEMORRHOIDALPHENYLEPHRINE HCLBliss GVS Pharma Limitedfceea303-2ea0-10e9-e053-6294a90a54922024-12-21WarningsExact identifier
application number: M015
DibucaineDIBUCAINE 1%Geri-Care Pharmaceuticals, Corpafe88610-5cac-960e-e053-2a95a90a7ba42024-12-20WarningsExact identifier
application number: M015
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELPharmacy Value Alliance, LLC7276aab8-0297-2a55-e053-2a91aa0a8d212024-12-20WarningsExact identifier
application number: M015
HemorrhoidalOintmentMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCIPharmacy Value Alliance, LLC3803a61b-308a-14a9-e054-00144ff88e882024-12-20WarningsExact identifier
application number: M015
Bliss GVS HemorrhoidalHARD FAT, PHENYLEPHRINE HCLBliss GVS Pharma Limited88c49f6c-2a48-2dae-e053-2a95a90af20a2024-12-19WarningsExact identifier
application number: M015
Rectal Care Cream RevivolLIDOCAINE 5%Derma Care Research Labsa1c75161-f84a-e996-e053-2a95a90ac0c52024-12-19WarningsExact identifier
application number: M015
DCH Numbing ReliefLIDOCAINE 5%Derma Care Research Labs, LLCffd70a31-7d0c-d2d0-e053-6394a90a86742024-12-19WarningsExact identifier
application number: M015
DCH HemorrhoidalGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Derma Care Research Labs, LLC0050701f-4393-3f01-e063-6394a90a4e0e2024-12-19WarningsExact identifier
application number: M015
Moshe Numbing HemorrhoidalLIDOCAINE 5%Derma Care Research Labsfbd5b488-1921-e9b7-e053-6294a90aba702024-12-19WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
83004-039-01830040039011 PACKAGE in 1 CARTON (83004-039-01) / 25 PATCH in 1 PACKAGE / 4 mL in 1 PATCH1 package2024-12-12NoNoCurrent