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 12 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d2ecb86-6bb1-2528-e063-6394a90a8d892025-08-25WarningsExact identifier
application number: M015
Cooling Perineal Pad LinersCOOLING PERINEALELEEO BRANDS LLC29a433bc-a833-ffc7-e063-6294a90a465a2025-08-25WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d3b771f-5e30-b23e-e063-6294a90a3fb22025-08-25WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
application number: M015
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
application number: M015
Lidocaine PatchLIDOCAINE 4%SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS0a31ba9a-8283-4bf8-b6c6-6e331465622f2025-08-20WarningsExact identifier
application number: M015
VBBV Anorectal(Hemorrhoidal) CreamsLIDOCAINEJiashen International Trading Co., Ltd.3cba84ea-5ee0-7ee3-e063-6294a90af11b2025-08-19WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
application number: M015
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
application number: M015
Norms HemorrhoidPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZELTotally Normal Company3c98cc12-2476-9f73-e063-6394a90a6f232025-08-17WarningsExact identifier
application number: M015
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
application number: M015
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
application number: M015
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
application number: M015
AsteroidMENTHOL, PETROLATUM, ZINC OXIDEHEALTHTEX LIMITED29d1e46d-0189-4f9e-9963-8a9de2757f282025-07-30WarningsExact identifier
application number: M015
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
application number: M015
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
application number: M015
Dr Butlers HemorrhoidWITCH HAZEL 50%Beyond Health, PA3a9fea0c-b189-c77e-e063-6294a90a05832025-07-23WarningsExact identifier
application number: M015
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
application number: M015
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact 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