FDA.reportPublic FDA data

Hemorroidal Cooling gel

Product NDC
68016-054
11-digit product format
680160054
Labeler code
68016
Product ID
68016-054_29b73242-ddd9-37e0-e063-6394a90a7da9
Type
HUMAN OTC DRUG
Nonproprietary name
Phenylephrine, Witch Hazel
Dosage form
GEL
Route
TOPICAL
Labeler
Pharmacy Value Alliance, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-08-02
Substance
WITCH HAZEL; PHENYLEPHRINE HYDROCHLORIDE
Active strength
.5; .25 g/100g; g/100g
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
Hemorroidal Cooling gel
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL.5 g/100g
PHENYLEPHRINE HYDROCHLORIDE.25 g/100g

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
101I4J0U34Internal UNII lookup
04JA59TNSJInternal UNII lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
7276aab8-0297-2a55-e053-2a91aa0a8d21Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

Effective, Related label table
EffectiveRelated label
2023-05-09Hemorrhoidal Cooling Gel
2023-01-30Hemorrhoidal Cooling Gel
2021-10-26Hemorrhoidal Cooling Gel
2021-01-29Hemorrhoidal Cooling Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-054-09Hemorroidal Cooling gel1 in 1 BOXGEL14
68016-054-09Hemorroidal Cooling gel26 g in 1 TUBEGEL264

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-054HEMORROIDAL COOLING GEL (PHENYLEPHRINE, WITCH HAZEL) GEL [PHARMACY VALUE ALLIANCE, LLC]4Current NDC, Legacy NDC, 2 package rows20241222_7276aab8-0297-2a55-e053-2a91aa0a8d21.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 4 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
HEMORRHOIDALMINERAL, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDECVS PHARMACY, INC93482a9b-145b-42d4-96db-599c281a39f12026-06-10WarningsExact identifier
application number: M015
Oudetas Lidocaine CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.53f11395-f460-943f-e063-6294a90affef2026-06-10WarningsExact identifier
application number: M015
Terramed Just Think Comfort Hemorrhoidal WipesLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDERida LLCf6ad00e7-c7b8-40b8-80c2-6e6bf85098b32026-06-08WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELCVS Pharmacy, Inc.50f920da-b41a-480d-b3a0-df940caaee2d2026-06-08Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd5356cf53-935d-a02f-e063-6394a90a6e5a2026-06-05WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMHyVee Incb867f691-7a13-4659-b664-06aa368993102026-06-03WarningsExact identifier
application number: M015
Healcome Lidocaine Numbing CreamLIDOCAINEYITONGBADA (SHENZHEN) INTERNATIONAL TRADE CO., LTD9b4eac02-1b1f-4630-92b4-b1d8c21abab52026-05-29WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Lavender and chamomileTOLNAFTATERida LLC5517c43f-03b2-499a-a217-d9cba3fb9fd22026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash CitrusTOLNAFTATERida LLCb4c5da66-5928-4352-ab90-fd46039e79552026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort GynoCare BV Guard Intimate WipesPRAMOXINE HYDROCHLORIDERida LLCbb29f156-37b8-400e-802b-3e2671cb7dc82026-05-27WarningsExact identifier
application number: M015
myDerm MEDICAL NEW Soothing HemorrhoidalWITCH HAZEL PENYLEPHRINE LIDOCAINEInspec Solutions2ff42501-7730-42de-99dd-6fc53bbdf25f2026-05-27WarningsExact identifier
application number: M015
Terramed Just Think Comfort Armor Antifungal Body Wash Icy Cool MentholTOLNAFTATERida LLC8b15cb3b-f7cb-4a80-94b2-eeeafc9794e82026-05-27WarningsExact identifier
application number: M015
Lidocaine Roll-onLIDOCAINEYYBA Corp52d060df-2095-dd68-e063-6394a90a77402026-05-27WarningsExact identifier
application number: M015
PUVIDA NUMBING Cream Anorectal (Hemorrhoidal) CreamLIDOCAINE 5% NUMBING CREAM ANORECTAL (HEMORRHOIDAL) CREAMJiangxi Yudexi Pharmaceutical Co., LTD52a25b97-7721-6410-e063-6394a90a228f2026-05-25WarningsExact identifier
application number: M015
Arlun LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5241c26b-6c91-65a5-e063-6394a90a24772026-05-20WarningsExact identifier
application number: M015
tuiwaro LIDOCAINE CreamLIDOCAINE CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5223b7fe-6aba-c77b-e063-6394a90ad27b2026-05-18WarningsExact identifier
application number: M015
HEMORRHOIDAL WITH LIDOCAINEGLYCERIN, LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE, WHITE PETROLATUMCVS PHARMACY, INC4d870c68-9e72-464e-b0b8-900d0d661e432026-05-14WarningsExact identifier
application number: M015
OxifyLIDOCAINE 5%Weeks & Leo Compnay, INC.51cd58f7-c1c9-f4e2-e063-6294a90ad9702026-05-14WarningsExact identifier
application number: M015
Lidocaine anorectal creamLIDOCAINE 5%EveryMarket Inc1604daec-812f-4684-ba98-fbcda07a74612026-05-12WarningsExact identifier
application number: M015
PREPARATION H SOOTHING RELIEF CLEANSING AND COOLING WIPESWITCH HAZELHaleon US Holdings LLC485437a8-b2e9-4acf-a20e-edb1f08a9cae2026-05-11WarningsExact identifier
application number: M015

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
68016-054-09680160054091 TUBE in 1 BOX (68016-054-09) / 26 g in 1 TUBE1 tube2018-08-020000-00-00NoNoCurrent