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…

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 22 · 434 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Gembooxt Topical Numbing CreamLIDOCAINEGuangdong Quadrant Ecological Technology Co., Ltd.49951a3e-3b62-3d66-e063-6294a90a93602026-08-12WarningsExact identifier
application number: M015
NumbMD Lidocaine Cream Anorectal(hemorrhoidal)LIDOCAINE 5%EveryMarket Inc52379055-d017-4d98-e063-6294a90a196c2026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc52369a41-820d-cd7a-e063-6394a90ac6d12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD Lidocaine CreamLIDOCAINE 5%EveryMarket Inc51d370b4-1c34-d203-e063-6394a90a80b12026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD 5% Lidocaine creamLIDOCAINE 5%EveryMarket Inc507d0c2c-9517-40f8-e063-6394a90a19962026-08-12WarningsExact identifier
application number: M015
Nupharmisto NumbMD LIDOCAINE cream anorectal (hemorrhoidal)LIDOCAINE CREAM ANORECTALEveryMarket Inc483d81a3-7493-3391-e063-6394a90a2e3d2026-08-12WarningsExact identifier
application number: M015
Numbing CreamLIDOCAINE100 KARMA INC35b5ba9d-da1d-55d6-e063-6294a90a5fa82026-08-12WarningsExact identifier
application number: M015
Treatonic hemorrhoid treatment5% LIDOCAINE100 KARMA INC41442fa7-c511-07ca-e063-6294a90a39922026-08-12WarningsExact identifier
application number: M015
Lidocaine numbing cream5% LIDOCAINE100 KARMA INC47380721-6633-4a50-e063-6394a90aca942026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC47dc7630-9a74-1989-e063-6294a90a50bb2026-08-12WarningsExact identifier
application number: M015
Treatonic 5% Lidocaine Cream5% LIDOCAINE CREAM100 KARMA INC49e6b69f-bd6e-b415-e063-6394a90a8e652026-08-12WarningsExact identifier
application number: M015
THE SOLU TIONLIDOCAINE HYDROCHLORIDE AND EPINEPHRINE HYDROCHLORIDESCALP TECH INC58793581-8826-9a74-e063-6294a90a24652026-08-06WarningsExact identifier
application number: M015
Lidocaine Numbing CreamLIDOCAINEGuangzhou Liuquanmiao Import & Export Trade Co., Ltd.5457b3d7-e6b6-34a7-e063-6394a90aa2402026-08-03WarningsExact identifier
application number: M015
HEMORRHOIDALCREAMPROCUREPHENYLEPHRINE HCL, PETROLATUM, MINERAL OILTWIN MED, LLCe9c44756-1c98-41be-e053-2995a90a35b42026-08-03WarningsExact identifier
application number: M015
Lidocaine HydrochlorideLIDOCAINE HYDROCHLORIDEYYBA CORP582a0001-da1e-909a-e063-6394a90a2b112026-08-03WarningsExact identifier
application number: M015
up and upPHENYLEPHRINE HYDROCHLORIDETarget Corporationb42775ae-44fe-487e-b9ca-21d9687020a92026-07-29WarningsExact identifier
application number: M015
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

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