FDA.reportPublic FDA data

AER

Product NDC
50289-3250
11-digit product format
502893250
Labeler code
50289
Product ID
50289-3250_2baae3c5-a04e-c51e-e063-6394a90a81c3
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
SOLUTION
Route
RECTAL; TOPICAL
Labeler
Birchwood Laboratories LLC
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2018-06-28
Substance
WITCH HAZEL
Active strength
500 mg/mL
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 · 2 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2025-01-11 03:41 UTC · source 2025-01-10excluded productproduct50289-3250UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…
2025-01-11 03:41 UTC · source 2025-01-10excluded packagepackage50289-325050289-3250-1UExcluded because listing certification expiredexcluded / ndc_excluded.zip0efc9e666f02…f202fb6c5f17…

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
AER
Brand name suffix
Pre-moistened Witch Hazel Pad
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL500 mg/mL

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 · 2 matching rows.

Identifier, FDA.report destination table
IdentifierFDA.report destination
844379Internal RxNorm lookup
1247719Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
1cca622f-0a6b-4f35-9355-34c249ee705eAvailable on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50289-3250-1AERPre-moistened Witch Hazel Pad40 in 1 JARSOLUTION406
50289-3250-1AERPre-moistened Witch Hazel Pad2.8 mL in 1 APPLICATORSOLUTION2.86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50289-3250-1EA - Each50289-3250c05692d4-5d66-4fbc-aafa-1ed8ae419bed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U34AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
Witch HazelACTIVE MOIETY101I4J0U34AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSLAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W7AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
GlycerinINACTIVE INGREDIENTPDC6A3C0OXAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9TAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULRAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1
WaterINACTIVE INGREDIENT059QF0KO0RAER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES INC]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50289-3250AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20250115_1cca622f-0a6b-4f35-9355-34c249ee705e.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 1 of 23 · 441 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Flarestop Hemorrhoid LidocaineLIDOCAINEChelsea Pharmacceuticals LLCb8a589f7-7131-4807-9bcb-84af3078e2582026-09-10WarningsExact identifier
application number: M015
BCBCYC Numbing CreamLIDOCAINE 5% NUMBING CREAMWenzhou Yuyuan Pharmaceutical Co., Ltd.5ab36566-ba2f-06ef-e063-6394a90a71b52026-09-10WarningsExact identifier
application number: M015
5% Lidocaine 10g5% LIDOCAINEChongqing Mandongzi Technology Co., Ltd5b10530f-47cd-c4bd-e063-6294a90aaa0a2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMRite Aid Corporation407c78ca-6fee-4ed6-b61b-711ec049c86e2026-09-09WarningsExact identifier
application number: M015
HemorrhoidalGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMCVS Pharmacy3167c918-a7d3-46a1-a85b-64f9c22916f22026-09-04WarningsExact identifier
application number: M015
Flushable Hemorrhoidal Medicated Wipes Maximum StrengthWITCH HAZELAmazon.com Services LLC41d756f3-e523-ed14-e063-6394a90ab8172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Signature Care Medicated Wipes Hemorrhoidal Wipes with Witch HazelHEMORRHOIDAL WIPES WITH WITCH HAZELBetter Living Brands LLCadf26111-70ba-596c-e053-2995a90ac6f12026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
up and up medicated wipes manixim strengthGENTLE HEMORRHOIDAL CARETarget Corporation271eab2b-ed13-39f1-e054-00144ff88e882026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
KROGER MEDICATED WIPES HEMORRHOIDAL WIPE WITH WITCH HAZEL AND ALOEWITCH HAZEL CLOTHThe Kroger Co.48c1598d-6667-446f-ac90-10ab945d06172026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazelWITCH HAZELOld East Main Co.2055289d-962e-46a9-b371-b5bb93dd46b42026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Equate Hemorrhoidal Medicated WipesWITCH HAZELWalmart Inc.8d57f054-77dc-4205-85f1-b65dcfde677b2026-09-03Warnings, Adverse reactionsExact identifier
application number: M015
Lidocaine CreamLIDOCAINEInvaDerm Corporation5a7273d1-1dbc-420e-e063-6294a90a86292026-09-01WarningsExact identifier
application number: M015
Lidocaine PhenylephrineLIDOCAINE PHENYLEPHRINEYYBA CORP5a72a190-2129-411e-e063-6394a90a08c22026-09-01WarningsExact identifier
application number: M015
INICEI 5% LIDOCAINE Numbing Cream5% LIDOCAINE NUMBING CREAMGuangzhou Jingliang Cosmetics Co., Ltd.5a65842f-27a1-268b-e063-6294a90a60542026-08-31WarningsExact identifier
application number: M015
AnievaLCLIDOCAINEBlackstone Products, LLCddaba14c-10de-44e2-ae13-9217e20cb48e2026-08-29WarningsExact identifier
application number: M015
Norms Hemorrhoid WipesWITCH HAZELTotally Normal Company5a1af50b-8d00-f589-e063-6394a90af86c2026-08-28WarningsExact identifier
application number: M015
LAIYINHE Numbing Cream Anorectal (Hemorrhoidal) CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.59f0fa16-5eb0-e6bb-e063-6294a90aacf52026-08-26WarningsExact identifier
application number: M015
Dude Hemorrhoidal WipesWITCH HAZELDude Productsfdf408ef-9392-a812-e053-6394a90a00172026-08-25WarningsExact identifier
application number: M015
Norms Medicated WipesWITCH HAZELTotally Normal Company3a78e109-3f7c-fb19-e063-6394a90ae78e2026-08-22WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEShanghai Chuangshi Medical Technology (Group) Co., Ltd.599b425a-0e96-76df-e063-6394a90a48ff2026-08-21WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
1247719A.E.R. 50 % Medicated PadPSN1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 50 % Medicated PadPSN1cca622f-0a6b-4f35-9355-34c249ee705e6
1247719witch hazel 500 MG/ML Medicated Pad [A.E.R. Witch Hazel]SBD1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 500 MG/ML Medicated PadSCD1cca622f-0a6b-4f35-9355-34c249ee705e6
1247719A.E.R. 50 % Medicated PadSY1cca622f-0a6b-4f35-9355-34c249ee705e6
1247719A.E.R. Witch Hazel 500 MG/ML Medicated PadSY1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 50 % Medicated PadSY1cca622f-0a6b-4f35-9355-34c249ee705e6
844379witch hazel 50 % Medicated WipesSY1cca622f-0a6b-4f35-9355-34c249ee705e6

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
50289-3250-15028932500140 APPLICATOR in 1 JAR (50289-3250-1) / 2.8 mL in 1 APPLICATOR40 applicator2018-06-280000-00-00NoNoCurrent