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

openFDA label cross-check#

Cross-check layer: openFDA label JSON enriches search and identifies hydration gaps. The DailyMed Structured Product Label remains the canonical label presentation on FDA.report. Every label matching the complete exact-identifier union is deduplicated and paginated below.

Matched openFDA labels page 1 of 22 · 422 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Acolye Numbing Cream Anorectal(Hemorrhoidal) CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd578fa642-ff30-e511-e063-6294a90a59872026-07-26WarningsExact identifier
application number: M015
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
application number: M015
Moisture BarrierMENTHOL 0.44%, ZINC OXIDE 20.6%Walgreen Company258f3392-0f42-21e8-e063-6294a90ae9ad2026-07-22WarningsExact identifier
application number: M015
RectaEase Hemorrhoid Relief CreamLIDOCAINETrifecta Pharmaceuticals USA LLCc054921a-9f1b-7c75-e053-2995a90a17382026-07-20WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEKORVIA GLOBAL Inc.5690db03-4d62-9660-e063-6394a90a2fc02026-07-14WarningsExact identifier
application number: M015
Gembooxt Topical Numbing CreamLIDOCAINE HCLGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-07-13WarningsExact identifier
application number: M015
Zmztuhua Numbing CreamLIDOCAINEGuangzhou Hechuang Commercial Service Co.,Ltd.56417dc6-c14b-ad17-e063-6294a90af7e52026-07-10WarningsExact identifier
application number: M015
Tina Davies IceCreamLIDOCAINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC6a2b3199-f405-4455-9a02-8885d24eef9c2026-07-09WarningsExact identifier
application number: M015
Drs pharmacy HEMORRHOIDALPHENYLEPHRINE HCL, WITCH HAZELOL PHARMA TECH, LLC Drs PHARMACY164169b9-0627-9d1a-e063-6294a90ac46d2026-07-09WarningsExact identifier
application number: M015
Witch HazelWITCH HAZELH E B09b814f4-86b5-4810-bf52-cc88396451c22026-07-07Warnings, Adverse reactionsExact identifier
application number: M015
Witch HazelWITCH HAZELADUSA Distribution, LLCc50d0496-6f09-43c2-9383-3250885968c92026-06-29Warnings, Adverse reactionsExact identifier
application number: M015
Adellina Lidocaine Numbing Cream Topical Anorectal CreamLIDOCAINEGuangdong Aimu Biological Technology Co., Ltd55260a3e-637a-c53b-e063-6394a90a1b092026-06-27WarningsExact identifier
application number: M015
Walgreens HemorrhoidalHEMORRHOIDAL RECTAL SUPPOSITORIESWalgreens20c41406-99b2-bc89-e063-6294a90aed732026-06-25WarningsExact identifier
application number: M015
CalaSootheCALAMINE, MENTHOL, AND ZINC OXIDEDynarex Corporation54f12005-acfe-4821-e063-6394a90ac3042026-06-24WarningsExact identifier
application number: M015
tina davies IceCream HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC10d2c3e4-cf4d-42ce-8fc3-33b97f63cccd2026-06-24WarningsExact identifier
application number: M015
Haemorrhoidal Pain ReliefANORECTAL CREAMNeilMed Pharmaceuticals Inc544a9d6f-4eaa-613e-e063-6294a90a0c502026-06-15WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-06-15WarningsExact identifier
application number: M015
Dr.Seymour Butts HemorrhoidLIDOCAINE5% PHENYLEPHRINE HCL 0.25% HEMORRHOIDJiangxi Yudexi Pharmaceutical Co., LTD4981c7d9-53ee-2a7b-e063-6394a90add012026-06-12WarningsExact identifier
application number: M015
ANIXIKE NumbingLIDOCAINE4% NUMBINGJiangxi Yudexi Pharmaceutical Co., LTD4d5b7c4c-feac-4eeb-e063-6294a90a57482026-06-11WarningsExact identifier
application number: M015
tina davies IceJelly HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDETINA DAVIES PROFESSIONAL LLC580559bf-d91f-4bb3-9c9b-b7e2cd0686fd2026-06-11WarningsExact identifier
application number: M015

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

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