FDA.reportPublic FDA data

Witch Hazel

Product NDC
0363-0803
11-digit product format
003630803
Labeler code
0363
Product ID
0363-0803_4aa55c4e-ecf9-e36d-e063-6394a90a2fb5
Type
HUMAN OTC DRUG
Nonproprietary name
WITCH HAZEL
Dosage form
LIQUID
Route
TOPICAL
Labeler
Walgreen Co.
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2016-06-23
Substance
WITCH HAZEL
Active strength
860 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
Current FDA listing
Yes

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
417ae199-54bb-420f-a3cf-1c096062d78cAvailable on FDA.report

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-0803-43Witch Hazel473 mL in 1 BOTTLE, PLASTICLIQUID47319

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-0803WITCH HAZEL LIQUID [WALGREENS CO]17Current NDC, Legacy NDC, 1 package rows20240608_417ae199-54bb-420f-a3cf-1c096062d78c.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 26 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
DERMATITIS FACE BALMCOLLOIDAL OATMEALSkinfix, Inc.86d2db7d-f1d4-4bca-aba4-d4c96b83c1a62026-01-08WarningsExact identifier
application number: M016
First Aid Beauty Dry Skin Rescue Kit 5x Hydration PowerCOLLOIDAL OATMEALJCS Global Distribution, Inc.47d06283-21cd-4a69-e063-6294a90adb052026-01-07WarningsExact identifier
application number: M016
DE LA CRUZ DIAPER RASHALLANTOIN, PETROLATUM, AND ZINC OXIDEDLC Laboratories, Inc.5949aa0f-a7cb-453c-81fd-9fa24653a4522026-01-07WarningsExact identifier
application number: M016
Thera Wise Natural HemorrhoidalWITCH HAZELDerma Wise Skin Care Ltd.a29fb680-cfc8-4a7b-9970-563fa0e2bed62026-01-06WarningsExact identifier
application number: M016
Sky and Sol SPF25 Lip BalmSKY AND SOL SPF25 LIP BALMGuangzhou Fantesy Biotechnology Co.,Ltd1f37c0c3-6443-60a3-e063-6394a90a596f2026-01-05WarningsExact identifier
application number: M016
Remedy EssentialsWHITE PETROLATUM,ZINC OXIDEMedline Industries, LP42a033d6-782b-2d7f-e054-00144ff8d46c2026-01-05WarningsExact identifier
application number: M016
BUNUSS Estriol FaceESTRIOLJiashen International Trade Limited478b5690-038a-ba1c-e063-6394a90a3ad62026-01-04WarningsExact identifier
application number: M016
Skin Protectant for Babies and kidsSKIN PROTECTANT OINTMENTNeilmed Pharmaceuticals Inc.448b70db-ca81-db7b-e063-6294a90a5f0d2026-01-02WarningsExact identifier
application number: M016
Puriya Eczema CreamCOLLOIDAL OATMEALIPC Republic, Inc.24ac044e-13fa-5ff6-e063-6294a90a99852026-01-01WarningsExact identifier
application number: M016
ScarzenDIMETHICONEVillage Pharma LLC1550f4e5-22e2-491f-8184-de65da7234e62026-01-01WarningsExact identifier
application number: M016
NUVALU 100 PURE PETROLEUMWHITE PETROLATUMJC SALES48f74b99-7ead-b0d0-e063-6394a90a49292026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMJC SALES48f79c2a-b314-169f-e063-6294a90a576e2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMJC SALES490ac0a6-eac0-a74f-e063-6394a90a84ed2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM COCOA BUTTERWHITE PETROLATUMJC SALES490af001-c78c-e2d2-e063-6394a90abdb02026-01-01WarningsExact identifier
application number: M016
NUVALU 100 PURE PETROLEUMWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.4946ac1a-f475-fbb1-e063-6394a90a30bc2026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.4946d1b7-ae1b-1e73-e063-6394a90a1ed22026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM BABY FRESH SCENTWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.49471d77-303a-8536-e063-6394a90aea512026-01-01WarningsExact identifier
application number: M016
NUVALU PETROLEUM COCOA BUTTERWHITE PETROLATUMNingbo Liyuan Daily Chemical Products Co., Ltd.49472319-09d1-7c4f-e063-6294a90a26a72026-01-01WarningsExact identifier
application number: M016
Olay Ultimate Sensitive Colloidal Oatmeal Skin Protectant Moisturizer Fragrance FreeCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company1fa6282a-172e-f5c8-e063-6294a90a4fb12025-12-31WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Vanilla LatteCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company27713ae6-b428-e0d7-e063-6394a90a7a892025-12-31WarningsExact identifier
application number: M016

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
200295witch hazel 86 % Topical SolutionPSN417ae199-54bb-420f-a3cf-1c096062d78c19
200295witch hazel 860 MG/ML Topical SolutionSCD417ae199-54bb-420f-a3cf-1c096062d78c19
200295witch hazel 86 % Topical SolutionSY417ae199-54bb-420f-a3cf-1c096062d78c19

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
0363-0803-4300363080343473 mL in 1 BOTTLE, PLASTIC (0363-0803-43) 473 ml2016-06-230000-00-00NoNoCurrent