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 48 of 68 · 1,357 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
NUDESCREEN DAILY MINERAL VEIL SPF 30 - TINT TAN	ZINC OXIDE	Bentley Laboratories, LLC	7920708a-6fa7-4bc8-94ba-096e77d9d7e1	2024-12-27	Warnings	Exact identifier application number: M016
AD Medicated Rash	AD MEDICATED RASH	WellSpring Pharmaceutical Corporation	aac345bf-ea66-4f5b-a497-c24ea72f93ea	2024-12-27	Warnings	Exact identifier application number: M016
ZO Skin Health Post Procedure Recovery System	ALUMINUM ACETATE	ZO Skin Health, Inc.	3b977415-2bf4-43a9-bb48-1eb023ca4f53	2024-12-27	Warnings	Exact identifier application number: M016
terrasil Scar Recovery	ALLANTOIN	Aidance Scientific, Inc., DBA Aidance Skincare & Topical Solutions	2a2f91ff-a447-9d2a-e063-6394a90a84f8	2024-12-26	Warnings	Exact identifier application number: M016
WITCH HAZEL	WITCH HAZEL	CHAIN DRUG MARKETING ASSOCIATION INC	bdccee3f-0ad8-4264-a65f-ae86aed6bf03	2024-12-26	Warnings	Exact identifier application number: M016
All Over Lavender Rosemary	COLLOIDAL OAT OINTMENT	Tubby Todd	29f46671-7467-95c9-e063-6294a90a1354	2024-12-23	Warnings	Exact identifier application number: M016
Sweet Cheeks Diaper Sprayer	ZINC OXIDE DIAPER PASTE SPRAY	Tubby Todd	29f4aa3c-d10e-52a5-e063-6294a90acc4b	2024-12-23	Warnings	Exact identifier application number: M016
calamine	CALAMINE AND ZINC OXIDE	WALGREEN COMPANY	fed3026b-3473-26fe-e053-6294a90a8aa2	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM, COD LIVER OIL	Miramar Cosmetics, Inc DBA Miramar Lab	fc9211db-71aa-44d8-a00b-65f1482d3981	2024-12-23	Warnings	Exact identifier application number: M016
CUREFINI	PETROLATUM	Miramar Cosmetics, Inc DBA Miramar Lab	6a2610ca-ca80-451f-8fed-b982443a10b9	2024-12-23	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	453dffec-de9d-0eac-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Vitamin A and D	LANOLIN, PETROLATUM	Trifecta Pharmaceuticals USA LLC	455a16fd-9ce5-6bef-e054-00144ff88e88	2024-12-20	Warnings	Exact identifier application number: M016
White Petrolatum	PETROLATUM	Trifecta Pharmaceuticals USA LLC	f1eb0ec2-98e7-13a2-e053-2a95a90a2938	2024-12-20	Warnings	Exact identifier application number: M016
Zinc Oxide 20%	ZINC OXIDE	Pharmacy Value Alliance, LLC	38018e3f-3778-01d1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
DiaperRashOintment	ZINC OXIDE	Pharmacy Value Alliance, LLC	3aace6d8-d24c-00e1-e054-00144ff8d46c	2024-12-20	Warnings	Exact identifier application number: M016
Medicated Body Powder	MENTHOL	New Pride Corp	f0f0e332-cb93-42a7-e053-2995a90ac4ae	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Medicated Body	MENTHOL AND ZINC OXIDE	International Wholesale Inc dba Home Smart Products	044870e2-ebac-a095-e063-6294a90a2751	2024-12-19	Warnings	Exact identifier application number: M016
White Rain Original Petroleum	WHITE PETROLEUM	INTERNATIONAL WHOLESALE INC.	d6ebe00c-b692-5171-e053-2a95a90a976c	2024-12-19	Warnings	Exact identifier application number: M016
Health Smart Original Petroleum	WHITE PETROLEUM	Home Smart Products	aedf746f-4c49-421d-a666-1ba02e8fb17d	2024-12-19	Warnings	Exact identifier application number: M016
white rain Cocoa Butter Petroleum Jelly	WHITE PETROLATUM	INTERNATIONAL WHOLESALE INC.	d7068e2b-c3b2-d16d-e053-2a95a90a6dd2	2024-12-19	Warnings	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