FDA.reportPublic FDA data

Drs. pharmacy HEMORRHOIDAL COOLING

Product NDC
80489-959
11-digit product format
804890959
Labeler code
80489
Product ID
80489-959_2b521bcb-3d08-f590-e063-6294a90a36c0
Type
HUMAN OTC DRUG
Nonproprietary name
phenylephrine HCL, witch hazel
Dosage form
GEL
Route
TOPICAL
Labeler
OL PHARMA TECH, LLC Drs PHARMACY
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2021-11-01
Substance
PHENYLEPHRINE HYDROCHLORIDE; WITCH HAZEL
Active strength
25; 500 mg/g; mg/g
Pharmacologic classes
Adrenergic alpha1-Agonists [MoA], alpha-1 Adrenergic Agonist [EPC]
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
Drs. pharmacy HEMORRHOIDAL COOLING
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
PHENYLEPHRINE HYDROCHLORIDE25 mg/g
WITCH HAZEL500 mg/g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
04JA59TNSJInternal UNII lookup
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
d6f6b482-d85d-001c-e053-2995a90ad98cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
80489-959-01Drs. pharmacy HEMORRHOIDAL COOLING20 g in 1 TUBEGEL208
80489-959-01Drs. pharmacy HEMORRHOIDAL COOLING1 in 1 CARTONGEL18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
80489-959DRS. PHARMACY HEMORRHOIDAL COOLING (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [OL PHARMA TECH, LLC DRS PHARMACY]8Current NDC, Legacy NDC, 2 package rows20250112_d6f6b482-d85d-001c-e053-2995a90ad98c.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 21 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Mayinglong HemorrhoidalPETROLATUM, ZINC OXIDEMayinglong Pharmaceutical Group Co., Ltd.b14192ea-1bf7-da6a-e053-2a95a90a5b5e2023-12-08WarningsExact identifier
application number: M015
Hemorrhoidal cooling gelPHENYLEPHRINE HCL, WITCH HAZELWALGREENS03bbe258-e00d-13cc-e063-6394a90ae3452023-12-05WarningsExact identifier
application number: M015
Hemorrhoidal Pain ReliefMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWALGREENS03bc5c1a-d493-5082-e063-6394a90ae87b2023-12-05WarningsExact identifier
application number: M015
Bloop Hemorrhoid Relief TopicalGLYCERIN, PETROLATUM, PHENYLEPHRINE HCL, PRAMOXINE HCLThree Nations Corp0b6419e3-f1c7-bdfe-e063-6294a90a5d922023-11-30WarningsExact identifier
application number: M015
Bloop Fissure Healing Anorectal TopicalLIDOCAINEThree Nations Corp0b645092-ebc4-e4bb-e063-6294a90ad4cf2023-11-30WarningsExact identifier
application number: M015
SIMPLY VITAL HEMORRHOID and ANORECTAL RELIEFLIDOCAINEALPHA PLANTS INC79fa4b89-382f-45fa-a792-90a9fe5bf5732023-11-11WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Prolong LubricatingBENZOCAINEPRODUCT MAX GROUP INC3bef5915-1c98-4011-baa9-ad0bbef200c22023-11-10WarningsExact identifier
application number: M015
BODY ACTION PRODUCTS Butt Eze BenzocaineBENZOCAINEPRODUCT MAX GROUP INCba75b129-7939-4373-91f5-1772976e6d612023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC441c802f-a363-1530-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
Uber Numb Topical AnestheticLIDOCAINE HYDROCHLORIDEUberScientific, LLC4939a547-c94b-3350-e054-00144ff88e882023-11-10WarningsExact identifier
application number: M015
DR REAL NUMB Topical AnorectalLIDOCAINEFUZZYLULU LLC378d8edc-2120-416d-854c-8881c2950efe2023-11-09WarningsExact identifier
application number: M015
The Pharma C Company Medicated Foam with Witch HazelWITCH HAZELKleen Test Products Corporation1a1fbe83-be45-4654-a7bb-e934e1ccd0c62023-11-09WarningsExact identifier
application number: M015
The Pharma-C Company Medicated Hemorrhoidal PadsWITCH HAZELKleen Test Products Corporation357703ab-4e7a-41f6-9ecf-aa98acc2d92e2023-11-09WarningsExact identifier
application number: M015
DOCTORS TOUCH Erase The Pain LidocaineLIDOCAINE HYDROCHLORIDEDOCTOR'S CHOICE MEDICAL, LLC3dc9947b-8196-4a38-97b4-c2340ee77e0f2023-11-06WarningsExact identifier
application number: M015
SCALAR Pain Relief CreamMENTHOLMiracle Balance, LLC52a13cfe-3f46-45f8-a5af-ce07ea5758e32023-11-06WarningsExact identifier
application number: M015
SIMPLE PROMISE Simple H Hemorrhoid Relief CreamPHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDESIMPLE PROMISE PTE LTDf6622caa-3b31-9b07-e053-2a95a90a8a512023-11-06WarningsExact identifier
application number: M015
WAXUP NumbingLIDOCAINE HYDROCHLORIDECONSTRUSOLUTION, LLC4f1645ab-1b19-4d69-99c3-9ea275b01a872023-11-06WarningsExact identifier
application number: M015
SECONDARY NUMB Lidocaine Phenylephrine GelLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDELALANI Rx Consulting, Inc.0f13f7b5-e3b1-451e-a6d6-e7e15bd044432023-11-06WarningsExact identifier
application number: M015
Brazzers Anal DesensitizingLIDOCAINEMetro Media Entceacd80c-0dd6-4e21-97da-56da877b1c902023-11-06WarningsExact identifier
application number: M015
NUMB PLUS Maximum Strength AnorectalLIDOCAINESEENEXT VENTURE LTDa7c37b2a-b647-43d7-b43b-87bbece354302023-11-05WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
80489-959-01804890959011 TUBE in 1 CARTON (80489-959-01) / 20 g in 1 TUBE1 tube2021-11-010000-00-00NoNoCurrent