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 dateDatasetScopeProduct NDCPackage NDCCodeStatusReporting periodArchiveSnapshotSource SHA-256
2019-12-08 06:16 UTC · source 2019-12-05excluded productproduct43347-158EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…a55b01930146…
2019-12-08 06:16 UTC · source 2019-12-05excluded packagepackage43347-15843347-158-01EExcluded after deficient or non-compliant submission was not correctedexcluded / ndc_excluded.zip110d247fa046…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
IngredientStrength
WITCH HAZEL3.36 g/28g

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
1804849Internal RxNorm lookup

Harmonized SPL set identifiers#

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

Identifier, FDA.report destination table
IdentifierFDA.report destination
a29fb680-cfc8-4a7b-9970-563fa0e2bed6Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43347-158-01Thera Wise Natural Hemorrhoidal28 g in 1 TUBE, WITH APPLICATOROINTMENT285
43347-158-01Thera Wise Natural Hemorrhoidal1 in 1 BOXOINTMENT15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43347-158THERA WISE NATURAL HEMORRHOIDAL (WITCH HAZEL) OINTMENT [DERMA WISE SKIN CARE LTD.]4Current NDC, Legacy NDC, 2 package rows20240119_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 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
ndc (product): 43347-158
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
1804849witch hazel 12 % Rectal OintmentPSNa29fb680-cfc8-4a7b-9970-563fa0e2bed65
1804849witch hazel 0.12 MG/MG Rectal OintmentSCDa29fb680-cfc8-4a7b-9970-563fa0e2bed65
1804849witch hazel 12 % Rectal OintmentSYa29fb680-cfc8-4a7b-9970-563fa0e2bed65

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionMarketing startMarketing endSampleExclude flagStatus
43347-158-01433470158011 TUBE, WITH APPLICATOR in 1 BOX (43347-158-01) / 28 g in 1 TUBE, WITH APPLICATOR2016-08-150000-00-00NoNoCurrent