Witch Hazel

Product NDC
55319-590
11-digit product format
553190590
Labeler code
55319
Product ID
55319-590_91446e91-3de9-4f16-ad3c-1b93ec333162
Type
HUMAN OTC DRUG
Nonproprietary name
Witch hazel
Dosage form
LIQUID
Route
TOPICAL
Labeler
Family Dollar (FAMILY WELLNESS)
Application
M016
Marketing category
OTC MONOGRAPH DRUG
Marketing start
2017-12-31
Substance
WITCH HAZEL
Active strength
842 mg/mL
NDC exclude flag
No
Listing certified through
2027-12-31
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 · 6 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source dateDatasetScopePackage NDCSnapshotSource SHA-256
2022-08-30 03:57 UTC · source 2022-08-29excluded productproductfb8cb913e6d1…eb8c232b6be0…
2022-08-30 03:57 UTC · source 2022-08-29excluded packagepackage55319-590-16fb8cb913e6d1…eb8c232b6be0…
2022-04-09 23:13 UTC · source 2022-04-08excluded productproduct86f5da6cb304…a595104c45d7…
2022-04-09 23:13 UTC · source 2022-04-08excluded packagepackage55319-590-1686f5da6cb304…a595104c45d7…
2022-04-04 05:40 UTC · source 2022-04-01excluded productproductbd6a592717d7…303034d00443…
2022-04-04 05:40 UTC · source 2022-04-01excluded packagepackage55319-590-16bd6a592717d7…303034d00443…

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 HAZEL842 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 SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a2047ef3-cda4-4411-a4c2-d7fb03f5b069Available on FDA.report

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55319-590-162022-12-07C16284748780-1d6a99b39-9f73-a426-e053-dadaa90af4c2Drug Facts
55319-590-162022-01-28C16284748780-1d6a99b39-9f73-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-590-16Witch Hazel473 mL in 1 BOTTLE, PLASTICLIQUID4735

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-590WITCH HAZEL LIQUID [FAMILY DOLLAR (FAMILY WELLNESS)]5Current NDC, Legacy NDC, 1 package rows20250209_a2047ef3-cda4-4411-a4c2-d7fb03f5b069.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 16 of 68 · 1,350 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Meijer Scar GelALLANTOIN 0.5%Meijer4c108c34-72f3-1382-e063-6394a90a7f2c2026-03-11WarningsExact identifier
application number: M016
E2 hand washE2 SANITIZING HAND SOAPHorizon Tool Inc.a40afa46-a07d-f864-e053-2a95a90aef8a2026-03-11WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Skin Protectant Sugar CookieCOLLOIDAL OATMEALThe Procter & Gamble Manufacturing Company4576cd28-9530-4db4-e063-6394a90a9fd32026-03-10WarningsExact identifier
application number: M016
Diaper RashZINC OXIDELidl US, LLCe399b33f-5f7c-47eb-8e9b-1721ae4680b52026-03-10Warnings, Adverse reactionsExact identifier
application number: M016
Vitamin A DWHITE PETROLATUMSion Biotext Medical Ltd.503c4ab9-1f60-48e2-af47-7ef996466a5b2026-03-09WarningsExact identifier
application number: M016
TrstayRETINOL SERUMShenzhen yuehaotong Technology Co.,Ltd4c6e20dd-0a71-a96b-e063-6294a90ab8332026-03-07WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c7f645-cfb3-6db1-e063-6394a90a42ff2026-03-06WarningsExact identifier
application number: M016
2-Pack Facial Serum2-PACK FACIAL SERUMGuangzhou Ariel Biotech Co., Ltd.27c89fc6-016b-d359-e063-6394a90a56022026-03-06WarningsExact identifier
application number: M016
BoudreauxsZINC OXIDEC.B. Fleet Company, Inc.f8f626c8-13ae-4b3b-ae3f-e0dc800fcb4a2026-03-06WarningsExact identifier
application number: M016
First Aid Beauty FAB Ultra Repair Rescue Barrier Balm Skin ProtectantDIMETHICONEThe Procter & Gamble Manufacturing Company276c68d4-e273-4e48-e063-6294a90ab16f2026-03-04WarningsExact identifier
application number: M016
Nicotine PatchesNICOTINE PATCHESZhejiang FTA Shengzuozhi Biotechnology Co., LTD4c1d00b3-313b-933f-e063-6294a90ac46f2026-03-03WarningsExact identifier
application number: M016
Zinc OxideZINC OXIDEAmazon.com Services LLC495fffd7-7b64-954a-e063-6394a90a81fd2026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
CalamineCALAMINE, PRAMOXINE HCLAmazon.com Services LLCaceb0b10-8c90-4a06-8c47-cd1a2b4676a32026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Witch HazelWITCH HAZELAmazon.com Services LLC134e07a1-5236-4088-baf9-1ff33126f7932026-03-03Warnings, Adverse reactionsExact identifier
application number: M016
Diaper RashZINC OXIDEOld East Main Co.7f56ab98-dbd8-412a-8c31-bb6302b7f3292026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
CalamineFERRIC OXIDE REDOld East Main Co.c38c77fd-abbf-4c87-a9c0-a0e21ed3f97d2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Pure petroleumWHITE PETROLATUMOld East Main Co.ae8583c0-1b52-461d-8506-ec7524f1b4c42026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Healing for BabiesPETROLATUMOld East Main Co.aa1acc24-56af-4708-bf76-23d4de3d089e2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
PetroleumWHITE PETROLATUMOld East Main Co.de8d8071-ecb2-4719-8c7b-7944f27810d62026-03-02Warnings, Adverse reactionsExact identifier
application number: M016
Clear Anti-ItchPRAMOXINE HCL, ZINC ACETATEOld East Main Co.91df1434-bce6-4c6e-beee-cb5ec1cc8fff2026-03-02Warnings, Adverse reactionsExact identifier
application number: M016

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startMarketing endSampleExclude flagStatus
55319-590-1655319059016473 mL in 1 BOTTLE, PLASTIC (55319-590-16) 473 ml2017-12-310000-00-00NoNoCurrent