Home NDC 43347-158 Thera Wise Natural Hemorrhoidal
Product NDC 43347-158
11-digit product format 433470158
Labeler code 43347
Product ID 43347-158_b0575217-f40b-44cc-a38d-9bb99fa49d00
Type HUMAN OTC DRUG
Nonproprietary name Witch Hazel
Dosage form OINTMENT
Route RECTAL; TOPICAL
Labeler Derma Wise Skin Care Ltd.
Application M016
Marketing category OTC MONOGRAPH DRUG
Marketing start 2016-08-15
Substance WITCH HAZEL
Active strength 3.36 g/28g
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 · 2 matching rows.
View current auxiliary records. · View the auxiliary file history.
Captured / source date, Dataset, Scope table Captured / source date Dataset Scope Product NDC Package NDC Code Status Reporting period Archive Snapshot Source SHA-256 2019-12-08 06:16 UTC · source 2019-12-05 excluded product product 43347-158 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…2019-12-08 06:16 UTC · source 2019-12-05 excluded package package 43347-158 43347-158-01 E Excluded after deficient or non-compliant submission was not corrected excluded / ndc_excluded.zip 110d247fa046…a55b01930146…
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 Thera Wise Natural Hemorrhoidal
Listing expiration 2027-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength WITCH HAZEL 3.36 g/28g
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 101I4J0U34 Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 1804849 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 43347-158-01 Thera Wise Natural Hemorrhoidal 28 g in 1 TUBE, WITH APPLICATOR OINTMENT 28 5 43347-158-01 Thera Wise Natural Hemorrhoidal 1 in 1 BOX OINTMENT 1 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 43347-158 THERA WISE NATURAL HEMORRHOIDAL (WITCH HAZEL) OINTMENT [DERMA WISE SKIN CARE LTD.] 4 Current NDC, Legacy NDC, 2 package rows 20240119_a29fb680-cfc8-4a7b-9970-563fa0e2bed6.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 45 of 68 · 1,357 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 43347-158-01 43347015801 1 TUBE, WITH APPLICATOR in 1 BOX (43347-158-01) / 28 g in 1 TUBE, WITH APPLICATOR 2016-08-15 0000-00-00 No No Current