FDA.reportPublic FDA data

Witch Hazel

Product NDC
37808-822
11-digit product format
378080822
Labeler code
37808
Product ID
37808-822_560688dc-1e94-094b-e063-6294a90ae436
Type
HUMAN OTC DRUG
Nonproprietary name
Witch Hazel
Dosage form
LIQUID
Route
TOPICAL
Labeler
H E B
Application
M015
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2015-06-18
Substance
WITCH HAZEL
Active strength
860 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 2 matching rows.

Dataset, Scope, Product NDC table
DatasetScopeProduct NDCPackage NDCCodeStatusReporting periodSource date
excluded packagepackage37808-82237808-822-45DDiscontinued by firm2026-10-15
excluded packagepackage37808-82237808-822-99DDiscontinued by firm2026-10-15

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 · 4 matching rows.

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

Captured / source date, Package NDC, Snapshot table
Captured / source datePackage NDCSnapshotSource SHA-256
2025-12-14 17:58 UTC · source 2025-12-0537808-822-45d630ba8d3edf…732f749b63fb…
2025-12-14 17:58 UTC · source 2025-12-0537808-822-99d630ba8d3edf…732f749b63fb…
2025-08-27 00:01 UTC · source 2025-08-2637808-822-45f5e01cc5f278…a2eaf40c39c3…
2025-08-27 00:01 UTC · source 2025-08-2637808-822-99f5e01cc5f278…a2eaf40c39c3…

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
Witch Hazel
Listing expiration
2027-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
WITCH HAZEL860 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 · 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
09b814f4-86b5-4810-bf52-cc88396451c2Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
37808-822-43Witch Hazel473 mL in 1 BOTTLE, PLASTICLIQUID47316
37808-822-45Witch Hazel946 mL in 1 BOTTLE, PLASTICLIQUID94616
37808-822-99Witch Hazel236 mL in 1 BOTTLE, PUMPLIQUID23616

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIIDailyMed labelSPL versionUploaded
WITCH HAZELACTIVE INGREDIENT101I4J0U34WITCH HAZEL LIQUID [H-E-B]1
WITCH HAZELACTIVE MOIETY101I4J0U34WITCH HAZEL LIQUID [H-E-B]1
ALCOHOLINACTIVE INGREDIENT3K9958V90MWITCH HAZEL LIQUID [H-E-B]1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
37808-822WITCH HAZEL LIQUID [H-E-B]14Current NDC, Legacy NDC, 3 package rows20240922_09b814f4-86b5-4810-bf52-cc88396451c2.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 12 of 22 · 438 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Signature Numb cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d2ecb86-6bb1-2528-e063-6394a90a8d892025-08-25WarningsExact identifier
application number: M015
Cooling Perineal Pad LinersCOOLING PERINEALELEEO BRANDS LLC29a433bc-a833-ffc7-e063-6294a90a465a2025-08-25WarningsExact identifier
application number: M015
Signature numbing cream5% LIDOCAINEShengnan (Guangzhou) Cosmetics Co., LTD3d3b771f-5e30-b23e-e063-6294a90a3fb22025-08-25WarningsExact identifier
application number: M015
Exchange Select HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLArmy & Air Force Exchange Service6c32af3e-5b60-4e3e-95c2-ada37a7d3b2a2025-08-22WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPadagis Israel Pharmaceuticals Ltd43826c68-0a20-460d-a7b5-f3e12395a7d02025-08-22WarningsExact identifier
application number: M015
Barrier Protectant CreamBARRIER CREAMCardinal Health539d9aac-75cf-4efd-bb3e-b465563304ca2025-08-21WarningsExact identifier
application number: M015
Lidocaine PatchLIDOCAINE 4%SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS0a31ba9a-8283-4bf8-b6c6-6e331465622f2025-08-20WarningsExact identifier
application number: M015
VBBV Anorectal(Hemorrhoidal) CreamsLIDOCAINEJiashen International Trading Co., Ltd.3cba84ea-5ee0-7ee3-e063-6294a90af11b2025-08-19WarningsExact identifier
application number: M015
HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLPublix Super Markets Inc7b360d3b-fb2b-4f35-a04d-203dd352933d2025-08-19WarningsExact identifier
application number: M015
Good Sense HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLL. Perrigo Company2492ee1b-01f1-46e7-8790-b6ebc48f2aff2025-08-19WarningsExact identifier
application number: M015
Norms HemorrhoidPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZELTotally Normal Company3c98cc12-2476-9f73-e063-6394a90a6f232025-08-17WarningsExact identifier
application number: M015
Upside Down Pain ReliefBENZOCAINE, GLYCERINFridababy, LLC31c2cd25-1fec-5ec5-e063-6394a90a24b42025-08-15WarningsExact identifier
application number: M015
DG Health HemorrhoidalMINERAL OIL, PETROLATUM, PHENYLEPHRINE HCLDolgencorp, LLCd9f12a34-7bd1-4ba5-b34b-1b641f58271a2025-08-12WarningsExact identifier
application number: M015
Norms HemorrhoidGLYCERIN, LIDOCAINE, PETROLATUM, PHENYLEPHRINE HCLTotally Normal Company3bdf8c74-3db6-1805-e063-6394a90aaba02025-08-08WarningsExact identifier
application number: M015
AsteroidMENTHOL, PETROLATUM, ZINC OXIDEHEALTHTEX LIMITED29d1e46d-0189-4f9e-9963-8a9de2757f282025-07-30WarningsExact identifier
application number: M015
Comfort Candy HemorrhoidalLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEBOWLER ESTHETICS, INC4951d984-3e86-4eb6-9505-2c506e22fda22025-07-23WarningsExact identifier
application number: M015
Doctor Butler Hemorrhoid and Fissure Advanced FormulaGLYCERIN 37.5%, LANOLIN 12.5%, LIDOCAINE 4%, ZINC OXIDE 5%Beyond Health, PAd2a769e2-afd0-aed2-e053-2995a90ad4292025-07-23WarningsExact identifier
application number: M015
Dr Butlers HemorrhoidWITCH HAZEL 50%Beyond Health, PA3a9fea0c-b189-c77e-e063-6294a90a05832025-07-23WarningsExact identifier
application number: M015
Dr Butlers Advanced Hemorrhoid ReliefLIDOCAINE HCL 5%, PHENYLEPHRINE HCL 0.25%, WITCH HAZEL 50%Beyond Health. PA3aa0ee7a-3863-254d-e063-6394a90ad40e2025-07-23WarningsExact identifier
application number: M015
Dr. Butler Hemorrhoid TreatmentPHENYLEPHRINE HYDROCHLORIDE 0.25%, WITCH HAZEL 50%Beyond Health P.A.d2d1c81c-6443-c4b7-e053-2995a90a14d72025-07-22WarningsExact identifier
application number: M015

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200295witch hazel 86 % Topical SolutionPSN09b814f4-86b5-4810-bf52-cc88396451c216
200295witch hazel 860 MG/ML Topical SolutionSCD09b814f4-86b5-4810-bf52-cc88396451c216
200295witch hazel 86 % Topical SolutionSY09b814f4-86b5-4810-bf52-cc88396451c216

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
37808-822-4337808082243473 mL in 1 BOTTLE, PLASTIC (37808-822-43) 473 ml2015-06-180000-00-00NoNoCurrent
37808-822-4537808082245946 mL in 1 BOTTLE, PLASTIC (37808-822-45) 946 ml2015-06-180000-00-00NoNoCurrent
37808-822-9937808082299236 mL in 1 BOTTLE, PUMP (37808-822-99) 236 ml2015-06-180000-00-00NoNoCurrent