FDA.reportPublic FDA data

medicated wipes

Product NDC
41250-988
11-digit product format
412500988
Labeler code
41250
Product ID
41250-988_39ad5009-370b-0d4b-e063-6294a90ad1bf
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
PATCH
Route
TOPICAL
Labeler
Meijer Distribution Inc.
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-28
Substance
WITCH HAZEL
Active strength
500 mg/1000mg
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Observed NDC auxiliary status history#

This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.

Historic NDC status page 1 of 1 · 12 matching rows.

View current auxiliary records. · View the auxiliary file history.

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41250-988-48fb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage41250-988-96fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41250-988-4886f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41250-988-9686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41250-988-48bd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41250-988-96bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41250-988-488dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41250-988-968dfbde2a14a4…c9ff85d89658…

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
medicated wipes
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL500 mg/1000mg

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
ba0f3f9a-95d1-4d8a-86d1-2c25c945118cAvailable on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Related label table
NDCEffectiveRelated label
41250-988-482022-12-19Drug Facts
41250-988-962022-12-19Drug Facts
41250-988-482021-01-29Drug Facts
41250-988-962021-01-29Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-988-48medicated wipes500 mg in 1 PATCHPATCH5004
41250-988-48medicated wipes48 in 1 BOXPATCH484
41250-988-96medicated wipes500 mg in 1 PATCHPATCH5004
41250-988-96medicated wipes96 in 1 BAGPATCH964

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-988MEDICATED WIPES (WITCH HAZEL) PATCH [MEIJER DISTRIBUTION INC.]3Current NDC, Legacy NDC, 4 package rows20240113_ba0f3f9a-95d1-4d8a-86d1-2c25c945118c.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 PadPSNba0f3f9a-95d1-4d8a-86d1-2c25c945118c4
844379witch hazel 500 MG/ML Medicated PadSCDba0f3f9a-95d1-4d8a-86d1-2c25c945118c4
844379witch hazel 50 % Medicated PadSYba0f3f9a-95d1-4d8a-86d1-2c25c945118c4
844379witch hazel 50 % Medicated WipesSYba0f3f9a-95d1-4d8a-86d1-2c25c945118c4

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-988-484125009884848 PATCH in 1 BOX (41250-988-48) / 500 mg in 1 PATCH48 patch2019-10-020000-00-00NoNoCurrent
41250-988-964125009889696 PATCH in 1 BAG (41250-988-96) / 500 mg in 1 PATCH96 patch2019-10-020000-00-00NoNoCurrent