Hemorrhoidal Hygiene pads

Product NDC: 54162-004
11-digit product format: 541620004
Labeler code: 54162
Product ID: 54162-004_b08efcdb-c3c8-4d01-9622-c078af808bc5
Type: HUMAN OTC DRUG
Nonproprietary name: witch hazel
Dosage form: SOLUTION
Route: RECTAL
Labeler: Geritrex, LLC
Application: part346
Marketing category: OTC MONOGRAPH FINAL
Marketing start: 2015-07-31
Marketing end: 0000-00-00
Substance: WITCH HAZEL
Active strength: 50 g/100mL
NDC exclude flag: No
Listing certified through: 2019-12-31
Current FDA listing: Historical FDA.report record

NDC auxiliary status#

These records are reproduced from FDA’s unfinished, excluded, and compounder listings. They describe what appeared in the source files; a missing record does not establish a regulatory status. View all current auxiliary records, including entries without an NDC. · View the auxiliary file history.

Current NDC status page 1 of 1 · 4 matching rows.

Dataset, Scope, Product NDC table
Dataset	Scope	Product NDC	Package NDC	Code	Status	Source date
excluded product	product	54162-004		I	Inactivated by FDA	2026-10-12
excluded product	product	54162-004		I	Inactivated by FDA	2026-10-12
excluded package	package	54162-004	54162-004-01	I	Inactivated by FDA	2026-10-12
excluded package	package	54162-004	54162-004-25	I	Inactivated by FDA	2026-10-12

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 2 · 84 matching rows.

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

Captured / source date, Dataset, Scope table
Captured / source date	Dataset	Scope	Package NDC	Snapshot	Source SHA-256
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded product	product		`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-004-01	`d630ba8d3edf…`	`732f749b63fb…`
2025-12-14 17:58 UTC · source 2025-12-05	excluded package	package	54162-004-25	`d630ba8d3edf…`	`732f749b63fb…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded product	product		`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-004-01	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-08-27 00:01 UTC · source 2025-08-26	excluded package	package	54162-004-25	`f5e01cc5f278…`	`a2eaf40c39c3…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded product	product		`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-004-01	`2ef7874e63bc…`	`57b86245f4fa…`
2025-04-01 02:39 UTC · source 2025-03-31	excluded package	package	54162-004-25	`2ef7874e63bc…`	`57b86245f4fa…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded product	product		`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-004-01	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-28 20:22 UTC · source 2025-03-28	excluded package	package	54162-004-25	`a1b67e2a42f9…`	`c4cf2c586c0d…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded product	product		`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-004-01	`cfe11265f3b6…`	`090c488252e2…`
2025-03-22 03:12 UTC · source 2025-03-21	excluded package	package	54162-004-25	`cfe11265f3b6…`	`090c488252e2…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded product	product		`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-004-01	`cdf11ea48f46…`	`ba0047e9e063…`
2025-03-10 12:48 UTC · source 2025-03-10	excluded package	package	54162-004-25	`cdf11ea48f46…`	`ba0047e9e063…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded product	product		`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-004-01	`302b2466d912…`	`e7b80fea0513…`
2025-02-02 03:52 UTC · source 2025-01-31	excluded package	package	54162-004-25	`302b2466d912…`	`e7b80fea0513…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded product	product		`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-004-01	`ed331223b511…`	`672a5bd82f5f…`
2025-01-20 13:05 UTC · source 2025-01-20	excluded package	package	54162-004-25	`ed331223b511…`	`672a5bd82f5f…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded product	product		`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-004-01	`0efc9e666f02…`	`f202fb6c5f17…`
2025-01-11 03:41 UTC · source 2025-01-10	excluded package	package	54162-004-25	`0efc9e666f02…`	`f202fb6c5f17…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded product	product		`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-004-01	`ad56d346431e…`	`cc804d4bbf1e…`
2024-11-09 02:27 UTC · source 2024-11-08	excluded package	package	54162-004-25	`ad56d346431e…`	`cc804d4bbf1e…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded product	product		`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-004-01	`367a005e9d99…`	`383a685ebd0f…`
2024-10-04 04:10 UTC · source 2024-10-03	excluded package	package	54162-004-25	`367a005e9d99…`	`383a685ebd0f…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded product	product		`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-004-01	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-07-10 04:00 UTC · source 2024-07-09	excluded package	package	54162-004-25	`557ba5c1ecfa…`	`9c80585c8c6e…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded product	product		`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-004-01	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-28 21:12 UTC · source 2024-05-28	excluded package	package	54162-004-25	`8af77b9d5b6f…`	`d9bbb34c5368…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded product	product		`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-004-01	`834df4deac94…`	`adcc014656a3…`
2024-05-15 03:39 UTC · source 2024-05-14	excluded package	package	54162-004-25	`834df4deac94…`	`adcc014656a3…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded product	product		`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-004-01	`1332a3947898…`	`d4bfe170f9cd…`
2024-03-11 06:39 UTC · source 2024-03-08	excluded package	package	54162-004-25	`1332a3947898…`	`d4bfe170f9cd…`

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
d5e51f11-ad28-caa4-4b49-4143974782ad	Product name	1	20150831

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
54162-004-01	2020-01-31	C162847	48780-1	9d75b9d0-f90a-f424-e053-dadaa90a57ce	Hemrrhoidal Hygiene pads
54162-004-25	2020-01-31	C162847	48780-1	9d75b9d0-74ad-f424-e053-dadaa90a57ce	Hemrrhoidal Hygiene pads

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
54162-004-25	Hemorrhoidal Hygiene pads	45 mL in 1 JAR	SOLUTION	45		4
54162-004-01	Hemorrhoidal Hygiene pads	175 mL in 1 JAR	SOLUTION	175		3

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
54162-004-01	EA - Each	54162-004	67ce3d45-9157-4d39-9ecc-6ed0fddf3e25	1	2012-07-24
54162-004-25	EA - Each	54162-004	a972e8c9-75f4-4724-96f2-a4d06a65c43a	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	DailyMed label	SPL version
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
WITCH HAZEL	ACTIVE INGREDIENT	101I4J0U34	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
WITCH HAZEL	ACTIVE MOIETY	101I4J0U34	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
ACETYLTRIBUTYL CITRATE	INACTIVE INGREDIENT	0ZBX0N59RZ	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
ALCOHOL	INACTIVE INGREDIENT	3K9958V90M	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
DMDM HYDANTOIN	INACTIVE INGREDIENT	BYR0546TOW	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2
WATER	INACTIVE INGREDIENT	059QF0KO0R	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) RINSE [GERITREX CORP.]	2

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
54162-004	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) SOLUTION [GERITREX, LLC]	4	Legacy NDC, 1 package rows	20181229_e04a9fbf-69c0-469e-9d07-30711c3d6bf6.zip
54162-004	HEMORRHOIDAL HYGIENE PADS (WITCH HAZEL) SOLUTION [GERITREX, LLC]	3	Legacy NDC, 1 package rows	20181229_2b3fc4ab-c8f4-489f-8523-defd3a1b12f0.zip

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
844379	witch hazel 50 % Medicated Pad	PSN	e04a9fbf-69c0-469e-9d07-30711c3d6bf6	4
844379	witch hazel 500 MG/ML Medicated Pad	SCD	e04a9fbf-69c0-469e-9d07-30711c3d6bf6	4
844379	witch hazel 50 % Medicated Pad	SY	e04a9fbf-69c0-469e-9d07-30711c3d6bf6	4
844379	witch hazel 50 % Medicated Wipes	SY	e04a9fbf-69c0-469e-9d07-30711c3d6bf6	4
844379	witch hazel 50 % Medicated Pad	PSN	2b3fc4ab-c8f4-489f-8523-defd3a1b12f0	3
844379	witch hazel 500 MG/ML Medicated Pad	SCD	2b3fc4ab-c8f4-489f-8523-defd3a1b12f0	3
844379	witch hazel 50 % Medicated Pad	SY	2b3fc4ab-c8f4-489f-8523-defd3a1b12f0	3
844379	witch hazel 50 % Medicated Wipes	SY	2b3fc4ab-c8f4-489f-8523-defd3a1b12f0	3

Packages#

Package NDC, 11-digit format, Description table
Package NDC	11-digit format	Description	Units	Status
54162-004-01	54162000401	175 mL in 1 JAR	175 ml	Historical
54162-004-25	54162000425	45 mL in 1 JAR	45 ml	Historical

Title, Manufacturer, Effective date table
Title	Manufacturer	Effective date	Type	Version
Hemrrhoidal Hygiene pads	Geritrex, LLC	2018-12-24	HUMAN OTC DRUG LABEL	4
Hemrrhoidal Hygiene pads	Geritrex, LLC	2018-12-24	HUMAN OTC DRUG LABEL	3