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.

Identifier, FDA.report destination table
Identifier	FDA.report destination
a29fb680-cfc8-4a7b-9970-563fa0e2bed6	Available on FDA.report

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
ebc62596-fc97-4d03-9483-7ba095d25db7	Product name	1	20151210

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 19 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
Calamine	FERRIC OXIDE RED	Perrigo Direct, Inc	256bd1d4-fd50-408f-9aee-84f218bb4971	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum	WHITE PETROLATUM	Perrigo Direct, Inc	e11470b2-80d6-4008-b87e-eb6aeadfce74	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Perrigo Direct, Inc	cc0378f2-6d5f-47ec-b16a-64668b4c29cc	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXIND HCL	Perrigo Direct, Inc	54a20ec9-ab86-4410-af94-e04393e9d4b3	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Vitamin A D	LANOLIN, PETROLATUM	Meijer, Inc.	adc3bb9b-ed8a-4b65-b44c-1d1e978c89ec	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Meijer, Inc.	1b72f927-c2ae-4190-a035-5d7bb9f53c15	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Petroleum Skin Protectant	WHITE PETROLATUM	Meijer, Inc.	af293cc0-ccd5-42a6-861b-c19fa6ffd06a	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing for Babies	PETROLATUM	Meijer, Inc.	09878fe0-0890-4af3-a3f6-d2890041e9f8	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Clear Anti-Itch	PRAMOXINE HCL, ZINC ACETATE	Meijer, Inc.	fa8ae34c-7b68-454f-8a3b-0eaa93a34092	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Baby Diaper Rash	ZINC OXIDE	Meijer, Inc.	04bec667-a11e-42d2-a4b3-1416eebf1e8d	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Healing	PETROLATUM	Meijer, Inc.	8cb56ee4-b9d1-4a29-88c7-e6f3ac2112c1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	CALAMINE, PRAMOXINE HCL	Meijer, Inc.	6b369ef2-fd54-4931-a9eb-0fb42834c2ef	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Dimethicone	DIMETHICONE	Meijer, Inc.	75b91b97-ea84-4c4d-9e58-5a9ff27a778c	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Colloidal oatmeal	COLLOIDAL OATMEAL	Meijer, Inc.	d36a7479-7b3b-49fe-8144-b5cce0e173fb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Daily Moisturizing	DAILY MOISTURIZING	Meijer, Inc.	44949b46-70f2-4e52-adba-a8455da614eb	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Witch Hazel	WITCH HAZEL	Meijer, Inc.	13e4aece-5b91-4f89-a912-540bf170a8d1	2026-02-19	Warnings, Adverse reactions	Exact identifier application number: M016
Diaper Rash	ZINC OXIDE	Target Corporation	7fb5f9ca-cd90-4933-9fe8-907ece00458b	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Calamine	FERRIC OXIDE RED	Target Corporation	d4ee05c8-ae62-45df-8783-1ed57fa030ec	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Pure petroleum	WHITE PETROLATUM	Target Corporation	5237c7f2-7135-4558-a758-4fc2a232172f	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016
Advanced Healing	PETROLATUM	Target Corporation	3e620e4f-9e29-9e39-e063-6394a90adeda	2026-02-18	Warnings, Adverse reactions	Exact identifier application number: M016

UNII, Preferred term, Matched term table
UNII	Preferred term	Matched term
101I4J0U34	WITCH HAZEL	WITCH HAZEL

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	DailyMed	SPL version
1804849	witch hazel 12 % Rectal Ointment	PSN	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	5
1804849	witch hazel 0.12 MG/MG Rectal Ointment	SCD	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	5
1804849	witch hazel 12 % Rectal Ointment	SY	a29fb680-cfc8-4a7b-9970-563fa0e2bed6	5

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