FDA.reportPublic FDA data

Witch Hazel

Product NDC
10565-040
11-digit product format
105650040
Labeler code
10565
Product ID
10565-040_48334703-dd80-8848-e063-6294a90a2cb9
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
LIQUID
Route
TOPICAL
Labeler
Hydrox Laboratories
Application
505G(a)(3)
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2011-12-21
Substance
WITCH HAZEL
Active strength
86 g/100mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
Witch Hazel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL86 g/100mL

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
200295Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
73391eb3-c17c-4104-93b1-2decfb2ebdf9Available on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10565-040-16Witch Hazel473 mL in 1 BOTTLE, PLASTICLIQUID47312

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U34WITCH HAZEL LIQUID [HYDROX LABORATORIES]1
Witch HazelACTIVE MOIETY101I4J0U34WITCH HAZEL LIQUID [HYDROX LABORATORIES]1
AlcoholINACTIVE INGREDIENT3K9958V90MWITCH HAZEL LIQUID [HYDROX LABORATORIES]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
10565-040WITCH HAZEL LIQUID [HYDROX LABORATORIES]11Current NDC, Legacy NDC, 1 package rows20241127_73391eb3-c17c-4104-93b1-2decfb2ebdf9.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 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Witch HazelWITCH HAZELHydrox Laboratories73391eb3-c17c-4104-93b1-2decfb2ebdf92026-01-12WarningsExact identifier
ndc (product): 10565-040

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200295witch hazel 86 % Topical SolutionPSN73391eb3-c17c-4104-93b1-2decfb2ebdf912
200295witch hazel 860 MG/ML Topical SolutionSCD73391eb3-c17c-4104-93b1-2decfb2ebdf912
200295witch hazel 86 % Topical SolutionSY73391eb3-c17c-4104-93b1-2decfb2ebdf912

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
10565-040-1610565004016473 mL in 1 BOTTLE, PLASTIC (10565-040-16) 473 ml2017-11-130000-00-00NoNoCurrent