FDA.reportPublic FDA data

Cooling Perineal Pad Liners

Product NDC
79747-010
11-digit product format
797470010
Labeler code
79747
Product ID
79747-010_3d373f90-e8c0-1014-e063-6294a90aa882
Type
HUMAN OTC DRUG
Nonproprietary name
Cooling Perineal
Dosage form
CLOTH
Route
TOPICAL
Labeler
ELEEO BRANDS LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2024-10-15
Substance
WITCH HAZEL
Active strength
.5 mg/mL
NDC exclude flag
No
Listing certified through
2026-12-31
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
Cooling Perineal Pad Liners
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL.5 mg/mL

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
29a433bc-a833-ffc7-e063-6294a90a465aAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
79747-010-01Cooling Perineal Pad Liners30 mL in 1 CASECLOTH304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
79747-010COOLING PERINEAL PAD LINERS (COOLING PERINEAL) CLOTH [ELEEO BRANDS LLC]1Current NDC, 1 package rows20241222_29a433bc-a833-ffc7-e063-6294a90a465a.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 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
79747-010-017974700100130 mL in 1 CASE (79747-010-01) 30 ml2024-10-15NoNoCurrent