FDA.reportPublic FDA data

Signature Care Medicated Cooling

Product NDC
21130-928
11-digit product format
211300928
Labeler code
21130
Product ID
21130-928_41c453e3-2df4-0425-e063-6294a90ae663
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
CLOTH
Route
TOPICAL
Labeler
Better Living Brands, LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-10-03
Substance
WITCH HAZEL
Active strength
500 mg/1
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
Signature Care Medicated Cooling
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL500 mg/1

Harmonized UNII identifiers#

UNII identifiers page 1 of 1 · 1 matching rows.

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

Harmonized RxCUI identifiers#

RxCUI identifiers page 1 of 1 · 1 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
844379Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
b35dc719-a5a2-4839-870d-25313d3f7c9bAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-928-00Signature Care Medicated Cooling100 in 1 JARCLOTH1008

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-928SIGNATURE CARE MEDICATED COOLING (WITCH HAZEL) CLOTH [BETTER LIVING BRANDS, LLC]7Current NDC, Legacy NDC, 1 package rows20241228_b35dc719-a5a2-4839-870d-25313d3f7c9b.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 19 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLMeijer Distribution Inc14319ba4-3bce-497c-a380-65bd24defc5d2024-10-17WarningsExact identifier
application number: M015
equate hemorrhoidalCOCOA BUTTER, PHENYLEPHRINE HCLWal-Mart Stores Inc581dd76f-d052-4448-8139-9a2e31891b252024-10-17WarningsExact identifier
application number: M015
Equate HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLWal-Mart Stores Inc81ecb091-38da-4b3e-a0a1-b4986b97ee092024-10-16WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLKroger Company5c81d564-f786-46e1-af8b-f47521fbae602024-10-16WarningsExact identifier
application number: M015
topcare hemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLTopco Associates LLC615e87e4-79e0-44d6-b563-3bcd5a9b2d932024-10-16WarningsExact identifier
application number: M015
Basic Care HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLAmazon.com Services LLCfe675174-fc95-4dd7-bd39-c209c6ce0f6c2024-10-16WarningsExact identifier
application number: M015
hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMMeijer Distribution Incfb170371-2e5d-43ca-a259-538a973ee3b82024-10-15WarningsExact identifier
application number: M015
topcare hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMTopco Associates LLC5e13da07-48cf-40bc-bb11-fd891886cbea2024-10-14WarningsExact identifier
application number: M015
hemorrhoidal maximum strength pain reliefGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMKroger Company3c8f90e2-fecf-4439-9faa-81a32ffe47532024-09-26WarningsExact identifier
application number: M015
equate hemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMWal-Mart Stores Inc5ccefdbd-bbbe-4cbf-9fdb-3c568643e14d2024-09-26WarningsExact identifier
application number: M015
Walgreens Hemorrhoidal Pain ReliefGLYCERIN 14.4%, LIDOCAINE 5%, PETROLATUM 15%, PHENYLEPHRINE HCL 0.25%Walgreense79ed7ae-0d06-2f88-e053-2995a90a1e352024-09-20WarningsExact identifier
application number: M015
hemorrhoidal reliefCOCOA BUTTER, PHENYLEPHRINE HCLRite Aid Corporationddafbdca-32c2-49c1-83d3-35b4155958c92024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLRite Aid Corporation8e1f223a-a3a0-4837-9847-2a3939fcc5952024-08-15WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLBryant Ranch Prepack485fd02f-bfea-41d0-90a1-f12fcfeb2a152024-08-14WarningsExact identifier
application number: M015
Up and Up Hemorrhoid MAX STRENGTH14.4% GLYCERIN, 0.25% PHENYLEPHRINE HCL, 1% PRAMOXINE HCL, 15% PETROLATUMTarget Corporation867677b5-fd1d-449e-966e-1de0b5c98afb2024-08-08WarningsExact identifier
application number: M015
Soothing Hemorrhoidal Wipes 50 Witch HazelWITCH HAZELThe Honey Pot Company LLC1ea202f5-e228-b3f2-e063-6294a90a16c12024-08-01WarningsExact identifier
application number: M015
Bunnies Bum Hemorrhoidal NumbingLIDOCAINEFloCal Distributors LLC1c809643-0cbe-568f-e063-6394a90a32102024-07-05WarningsExact identifier
application number: M015
Bunnies Bum Soothing HemorrhoidalGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLFloCal Distributors LLC1c81582c-7ece-182f-e063-6294a90a8fbc2024-07-05WarningsExact identifier
application number: M015
MegaBabe Butt Stuff HemorrhoidalCOCOA BUTTER, GLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HYDROCHLORIDEMEGABABE, LLC01c156ff-69f9-4d5e-a9ea-abbc52d4afff2024-06-12WarningsExact identifier
application number: M015
PUREGEN LABS Maximum Strength LidocaineLIDOCAINEAdvanced Rx LLCf4f89582-49e6-424a-bea7-0694484a7c992024-04-11WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSNb35dc719-a5a2-4839-870d-25313d3f7c9b8
844379witch hazel 500 MG/ML Medicated PadSCDb35dc719-a5a2-4839-870d-25313d3f7c9b8
844379witch hazel 50 % Medicated PadSYb35dc719-a5a2-4839-870d-25313d3f7c9b8
844379witch hazel 50 % Medicated WipesSYb35dc719-a5a2-4839-870d-25313d3f7c9b8

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
21130-928-0021130092800100 CLOTH in 1 JAR (21130-928-00) 100 cloth2016-10-030000-00-00NoNoCurrent