Xesso Rear Comfort Glide

Product NDC
81777-101
11-digit product format
817770101
Labeler code
81777
Product ID
81777-101_ef6f41d0-2ff3-0b4c-e053-2a95a90a5d74
Type
HUMAN OTC DRUG
Nonproprietary name
Lidocaine
Dosage form
GEL
Route
TOPICAL
Labeler
Premium Natural Cosmetics Inc
Application
M015
Marketing category
OTC MONOGRAPH FINAL
Marketing start
2021-06-01
Marketing end
0000-00-00
Substance
LIDOCAINE HYDROCHLORIDE
Active strength
5 g/100mL
Pharmacologic classes
Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]
NDC exclude flag
No
Listing certified through
2023-12-31
Current FDA listing
Historical FDA.report record

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

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 startMarketing endSampleExclude flagStatus
81777-101-0181777010101245 mL in 1 BOTTLE, PLASTIC (81777-101-01) 245 ml2021-06-010000-00-00NoNoCurrent
81777-101-0281777010102118 mL in 1 BOTTLE (81777-101-02) 118 ml2021-06-010000-00-00NoNoCurrent
81777-101-0381777010103473 mL in 1 BOTTLE, PUMP (81777-101-03) 473 ml2022-12-050000-00-00NoNoCurrent