FDA.reportPublic FDA data

hemorrhoidal pads

Product NDC
41250-868
11-digit product format
412500868
Labeler code
41250
Product ID
41250-868_39ad74f5-b6ff-96bf-e063-6394a90a3585
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 · 8 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 packagepackage41250-868-10fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage41250-868-1086f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage41250-868-10bd6a592717d7…303034d00443…
2021-12-27 23:28 UTC · source 2021-12-27excluded productproduct8dfbde2a14a4…c9ff85d89658…
2021-12-27 23:28 UTC · source 2021-12-27excluded packagepackage41250-868-108dfbde2a14a4…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
hemorrhoidal pads
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
53e39d22-a89e-4f95-8c64-abeb50f72ce7Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41250-868-102022-12-19C16284748780-1ba0f9c33-3d98-a910-e053-dadaa90a0b85Drug Facts
41250-868-102021-01-29C16284748780-1ba0f9c33-3d98-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41250-868-10hemorrhoidal pads100 in 1 BOXPATCH1004
41250-868-10hemorrhoidal pads500 mg in 1 PATCHPATCH5004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41250-868HEMORRHOIDAL PADS (WITCH HAZEL) PATCH [MEIJER DISTRIBUTION INC.]3Current NDC, Legacy NDC, 2 package rows20240113_53e39d22-a89e-4f95-8c64-abeb50f72ce7.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 22 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Family wellnessMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLFRONT PHARMACEUTICAL PLCcfdd61e3-e12e-491c-b2a8-90fae19e88702023-10-27WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, PETROLATUMFRONT PHARMACEUTICAL PLCeb1785f4-5876-443b-b175-9b59d65d1a482023-10-26WarningsExact identifier
application number: M015
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
application number: M015
Family WellnessPHENYLEPHRINE HCL, PETROLATUM, MINERALZhejiang Jingwei Pharmaceutical Co., Ltd.bfa195d7-d87f-43b5-bbf1-7ec3a451de052023-10-25WarningsExact identifier
application number: M015
MAXIMUM STRENGTH HEMORRHOIDAL RELIEF with Finger CotsLIDOCAINECVS PHARMACY, INC82aa128a-44cd-4907-b0f7-8a31e086d3e62023-10-25WarningsExact identifier
application number: M015
TheraPlus PlusPHENYLEPHRINE HCIZhejiang Jingwei Pharmaceutical Co., Ltd.edf9f8d5-f55d-4c31-adfb-ba77ca24cc3d2023-10-25WarningsExact identifier
application number: M015
Assured Bikini Smooth CreamLIDOCAINEZhejiang Jingwei Pharmaceutical Co., Ltd.fb9ddde3-3f40-467e-8aff-26570144f0fc2023-10-25WarningsExact identifier
application number: M015
Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
application number: M015
Family WellnessGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUMZhejiang Jingwei Pharmaceutical Co., Ltd.fde9cd90-d63c-4058-b46e-511fecea36ec2023-10-24WarningsExact identifier
application number: M015
Lidocaine 5%LIDOCAINEApnar Pharma LPceedce20-5723-5a9a-e053-2a95a90a17a12023-10-21WarningsExact identifier
application number: M015
Numquick Topical AnalgesicEPINEPHRINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDEUnit Dose, Ltd.3f64cbd3-6745-4397-9767-3adc3b301e0e2023-10-19WarningsExact identifier
application number: M015
Healquick Tattoo BalmPETROLATUMUnit Dose, Ltd.96f92c82-a79a-4d7e-ba0c-5ea67e2b6e862023-10-19WarningsExact identifier
application number: M015
Numpot Topical AnestheticLIDOCAINE, PETROLATUMUnit Dose, Ltd.9143b50b-7d76-4545-aa2e-1bb77ffb44ae2023-10-19WarningsExact identifier
application number: M015
Microcaine Topical AnalgesicLIDOCAINEUnit Dose, Ltd.5e8fa8b5-0524-4201-91e1-83e59a8f04152023-10-19WarningsExact identifier
application number: M015
NumstickPETROLATUM, LIDOCAINEUnit Dose, Ltd.127bbd87-5402-4da2-abf3-dac6367735ec2023-10-18WarningsExact identifier
application number: M015
ADVANCED NUMB Topical AnestheticLIDOCAINE HYDROCHLORIDEUber Scientific, LLC859d1cad-badf-4c42-9b08-daacb3fae8b42023-10-13WarningsExact identifier
application number: M015
Hemorrhoidal Pain Relief with Aloe and VitaminEHEMORRHOIDAL PAIN RELIEF WITH ALOE AND VITAMINENeilMed pharmaceuticals Inc.076b5021-8ba0-0204-e063-6294a90a33372023-10-11WarningsExact identifier
application number: M015
Zensa Numbing GelLIDOCAINE 5%, PHENYLEPHRINE HYDROCHLORIDE 0.25%Alera Skin Care Products Inc.065a6eec-3896-0da8-e063-6394a90a849d2023-09-27WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
844379witch hazel 50 % Medicated PadPSN53e39d22-a89e-4f95-8c64-abeb50f72ce74
844379witch hazel 500 MG/ML Medicated PadSCD53e39d22-a89e-4f95-8c64-abeb50f72ce74
844379witch hazel 50 % Medicated PadSY53e39d22-a89e-4f95-8c64-abeb50f72ce74
844379witch hazel 50 % Medicated WipesSY53e39d22-a89e-4f95-8c64-abeb50f72ce74

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
41250-868-1041250086810100 PATCH in 1 BOX (41250-868-10) / 500 mg in 1 PATCH100 patch2019-10-020000-00-00NoNoCurrent